CN101559223B - Idemic encephalitis diphtheria-pertussis-tetanus combined vaccine - Google Patents

Idemic encephalitis diphtheria-pertussis-tetanus combined vaccine Download PDF

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CN101559223B
CN101559223B CN2008100875987A CN200810087598A CN101559223B CN 101559223 B CN101559223 B CN 101559223B CN 2008100875987 A CN2008100875987 A CN 2008100875987A CN 200810087598 A CN200810087598 A CN 200810087598A CN 101559223 B CN101559223 B CN 101559223B
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group
vaccine
epidemic encephalitis
meningitis cocci
combined vaccine
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CN101559223A (en
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蒋仁生
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ANHUI ZHIFEI LONGCOM BIOPHARMACEUTICAL CO., LTD.
Chongqing Zhiren Biotech Company Ltd.
Beijing Zhifei Lvzhu Biopharmaceutical Co Ltd
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CHONGQING ZHIREN BIOTECH Co Ltd
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Abstract

The invention relates to an idemic encephalitis diphtheria-pertussis-tetanus combined vaccine, in particular to a combined vaccine which takes B group meningococcus outer membrane protein as a core, contains other group meningococcus coupling or uncoupling amylase antigens, and is formed by an idemic encephalitis vaccine and a diphtheria-pertussis-tetanus vaccine. The combined vaccine further contains hepatitis B virus antigens and inactivation poliovirus antigens. The combined vaccine is suitable for preventing infection caused by epidemic meningococcus and diphtheria-pertussis-tetanus interrelated pathogenicbacteria in crowds, can further prevent the infection caused by hepatitis B viruses and polioviruses, reduces the immunity injection times through multiple polyvalent vaccine immunization and lowers the secondary reaction frequency of vaccine inoculation.

Description

Idemic encephalitis diphtheria-pertussis-tetanus combined vaccine
Technical field
The technology of the present invention field can relate to epidemiology, Medical Microbiology, immunology, vaccinology, preventive medicine, prevents the microbial disease of one or several cause of diseases by immunity inoculation.
The present invention relates to a kind of brand-new combined vaccine, the associatings of a kind of vaccine of epidemic menigitis and white hundred broken vaccines can prevent epidemic cerebrospinal meningitis coccus, diphtheria, the pertussis of A, B, C, W135, Y serotype, the infection of clostridium tetani simultaneously.Combined vaccine of the present invention also further comprises antigen of hepatitis B virus and inactivated poliovirus antigen, can further prevent the infection of hepatitis B virus and poliovirus.Combined vaccine can reduce immune pin, reduces immune cost, increase the acceptability of vaccine, thereby enlarges Immunization coverage rate.
Background technology
Meningococcus mainly causes the generation of human body epidemic cerebrospinal meningitis, also can cause other respiratory tract diseases such as pneumonia.Pathogenic bacteria is present in patient or bacillicarrier's the nasopharyngeal secretions, passes through respiratory tract infection.Epidemic encephalitis popular has obvious seasonality and periodically, and the winter-spring season sickness rate is high, generally begins morbidity from annual January, and be the peak period March or April.According to statistics, annual 2 to April, and it is annual about 60% that the sickness rate of " epidemic encephalitis " accounts for, and is characterized in that onset is anxious, the state of an illness is heavy, it is many to change, it is fast, popular wide to propagate, break with tremendous force, and the case fatality rate height, hazardness is large.The crowd all can occur in each age group crowd the general susceptible of epidemic encephalitis coccus, but more is apt to occur in little age bracket child, and the patient mainly is the children below 15 years old, particularly 6 months to 2 years old infant.In recent years, also finding clinically has the adult to suffer from this disease, and adult's case fatality rate is high.
Epidemic encephalitis has 13 sero-group types, and wherein A, B, C and W135 type can cause eruption and prevalence.At Africa and Asia, for many years, epidemic encephalitis is all preponderated with the A type, and especially from Senegal, on Ethiopic area, African the Sahara " epidemic encephalitis band ", the Mongolia in Asia also reported once in 1994-1995 is very popular.The popular of other serotypes also happens occasionally, 2000-2001 but recently,, hundreds has infected the epidemic encephalitis that W135 causes,, the Burkina Faso in Africa in 2002 to Saudi haj person, 13000 patient infections W135 serotype epidemic encephalitis, cause 1500 death.Only 2002 1 year, the epidemic encephalitis case of World Health Organization's report reached 223000 examples.Epidemic encephalitis not only betides Asia and Africa, and also very common in North America and Europe, especially B group accounts for the over half of epidemic encephalitis case.Y group also can cause meningitis in child and teenager, but compares with other types, and it is easier to cause pneumonia in large age cohort, and in recent years, the disease that Y group's serotype causes comes back year by year in the U.S..
China also belongs to the hotspot of epidemic encephalitis, and nearly more than 30 years data shows that A group bacterium is the popular dominant bacteria of China always, sickness rate non-popular year be 3-10/10 ten thousand, capable year of rill is 30-50/10 ten thousand, the year of being very popular is up to 100-500/10 more than ten thousand.Since the nineties in last century, B group's epidemic encephalitis proportion is enlarging gradually, and especially in developed regions, epidemic cerebrospinal meningitis is more and more obvious to B group's bacterial type transition by A group.2000, C group's epidemic encephalitis also presented expansion trend at home, and 2004-2005, it is popular that China has 7 groupment epidemic encephalitiss, and wherein 5 are caused by C group, and 1 is A group, and 1 not quite clear.
Vaccine for epidemic encephalitis mainly contains epidemic encephalitis polysaccharide vaccine, epidemic encephalitis GL-PP combined vaccine and epidemic encephalitis 1 outer-membrane protein vaccine, for serotype comprise A, B, C, W135 and Y.Polysaccharide vaccine is not owing to a little less than the immunogenicity, be adapted at the routine immunization of this age cohort in child below 2 years old.The proteinpolysaccharide combined vaccine is converted into the T cell dependent type with the immunne response that polysaccharide antigen stimulates from T cell independent form, can use in the less age cohort, in the world existing epidemic encephalitis combined vaccine for A, C, W135 and Y.B group's polysaccharide substantially do not produce immunne response in human body, but a kind of improved B group's GL-PP combined vaccine is developed also because a composition in structure and the human nerve tissue is similar.The outer membrane protein of epidemic encephalitis also is a kind of protective antigen, and a plurality of national registrations use the OMV vaccine in South America, in the use of Norway also sufficient proof safety and the protection effect of vaccine.External also have a plurality of mechanisms carrying out the 1 outer-membrane protein vaccine development of A group and other sero-group types.At present, the vaccine of epidemic menigitis of China's approved listing comprises A group's epidemic encephalitis polysaccharide vaccine, A+C epidemic encephalitis polysaccharide vaccine, ACW135Y epidemic encephalitis 4 valency polysaccharide vaccines, AC epidemic encephalitis combined vaccine, and A group's epidemic encephalitis combined vaccine, ACW135Y tetravalence epidemic encephalitis combined vaccine, B group's epidemic encephalitis combined vaccine, A group's epidemic encephalitis 1 outer-membrane protein vaccine, OMV vaccine are in active development.
White hundred broken be for diphtheria, pertussis and tetanic preventing preparation, both at home and abroad for many years the use sufficient proof its safety and protection effect, be in the national the Immune Programming always, the goods that fundamental immunity comprises.White hundred broken vaccine compositions comprise diphtheria toxoid, pertussis composition, tetanus toxoid, according to the pertussis composition be the full cell of deactivation also or component divide into two kinds white hundred broken vaccines, a kind of is full cell white hundred broken vaccines, and another kind is acellular white hundred broken vaccines.In China, full cell white hundred broken vaccines and acellular white hundred broken vaccines have launch.
Multi-joint multivalence is a direction of Vaccine Development.Along with the development of science and technology, when safer, effective, quality controllable replacement vaccine occurred like the mushrooms after rain, more and more the novel vaccine for other infectious disease also was developed.The appearance of novel vaccine has enlarged the human kind that keeps off infection, but the thing followed is the significant lifting of immune time, need to use the pin that reduces immunity by uniting of vaccine.Combined vaccine has made things convenient for immunity inoculation, has strengthened the acceptability of vaccination, has also reduced the inoculation cost, can improve the inoculation coverage rate of vaccine.
Idemic encephalitis diphtheria-pertussis-tetanus combined vaccine is a kind of brand-new combination, can prevent simultaneously the infection of different shaped epidemic encephalitis diplococcus, diphtheria corynebacterium, Bordetella pertussis, clostridium tetani.Epidemic encephalitis A, B, C, W135, Y polysaccharide or protein vaccine unit price or multivalence and white hundred broken associatings, especially polysaccharide antigen exists with the form that is coupled to carrier protein, can use widely on the crowd, can making things convenient for from now on, country brings it in the Immune Programming of expansion into.
Summary of the invention
The present invention relates to a kind of brand-new combined vaccine, a kind of take B group meningitis cocci outer membrane protein as core and comprise the associatings of other group meningitis cocci coupling or non-coupling polysaccharide antigen and white hundred broken vaccines, can prevent simultaneously epidemic cerebrospinal meningitis coccus, diphtheria, the pertussis of A, B, C, W135, Y serotype, the infection of clostridium tetani, satisfy above-mentioned needs.Combined vaccine of the present invention also further comprises antigen of hepatitis B virus and inactivated poliovirus antigen, can further prevent the infection of hepatitis B virus and poliovirus.
On the one hand, a kind of combined vaccine, it is characterized in that, described combined vaccine comprises vaccine of epidemic menigitis and DPT vaccine, and wherein said vaccine of epidemic menigitis is formed by polysaccharide antigen core and that comprise other group meningitis cocci and a protein carrier coupling or non-coupling take B group meningitis cocci outer membrane protein composite.Wherein, described polysaccharide antigen derives from A, C, W135, the Y group meningitis cocci a kind, 2 kinds, 3 kinds or 4 kinds of capsular polysaccharide antigen and B group meningitis cocci outer membrane protein composite; Described B group's outer membrane protein composite is 1 valency, divalent or the multivalence outer membrane protein composite that derives from B group meningitis cocci different shaped bacterial strain.Further, described capsular polysaccharide is to exist with a carrier protein couplet form or non-coupling form, and described coupling form is that polysaccharide is connected with chemical covalent bond with carrier protein, forms bonding state.This carrier protein is selected from cross reacting material (CRM9, CRM197), DT-Pa (PT), OMV matter complex (OMP), epidemic encephalitis 64K outer membrane protein, hemophilus influenza P1, P2, P4, P5, P6 outer membrane protein, adhesin, Recombinant pseudomonas aeruginosa exotoxin A (rEPA), albumin or the blue albumen of spoon in tetanus toxoid (TT), diphtheria toxoid (DT), the sudden change diphtheria toxin, diphtherotoxin.
On the other hand, the present invention relates to a kind of combined vaccine, wherein further comprise antigen of hepatitis B virus, form epidemic encephalitis-whooping cough-hepatitis B combined vaccine.
On the one hand, the present invention relates to a kind of combined vaccine again, wherein also further comprise poliovirus antigen, form epidemic encephalitis-whooping cough-ridge ash combined vaccine.
Another aspect the present invention relates to a kind of combined vaccine, wherein also further comprises antigen of hepatitis B virus, poliovirus antigen, forms epidemic encephalitis-whooping cough-hepatitis B-ridge ash combined vaccine.
Another aspect the present invention relates to combined vaccine, wherein various compositions is sub-packed in respectively in two autonomous container, mixes inoculating when immunity; Or several compositions are prepared into independent vaccine, mix inoculating when immunity; Or just be sub-packed in the preparation in the container and become multiple vaccines.
Another aspect, combined vaccine of the present invention are any in liquid dosage form, freeze-dried formulation, capsule formulation, tablet, the pill or several.
Another aspect, combined vaccine of the present invention further comprise Alum adjuvant and other adjuvants, and wherein said Alum adjuvant is selected from aluminium hydroxide, aluminum sulfate or aluminum phosphate.
Again on the one hand, combined vaccine of the present invention is to carry out immunity by being selected from following mode: injection, oral, mucosa spraying or place.
In other words, emphasis of the present invention is found to be:
The first, the inventor finds, after will containing the vaccine of epidemic menigitis of A group meningitis cocci polysaccharide, C group meningitis cocci polysaccharide and B group meningitis cocci outer membrane protein composite and DPT vaccine and being mixed with combined vaccine, can strengthen the immunogenicity of pertussis antigen;
The second, the inventor finds, to contain be mixed with combined vaccine with the A group meningitis cocci polysaccharide of a protein carrier coupling, with the vaccine of epidemic menigitis of a protein carrier coupling C group meningitis cocci polysaccharide and B group meningitis cocci outer membrane protein composite and DPT vaccine after, can strengthen the immunogenicity of pertussis antigen;
Three, the inventor finds, behind increase W135 group meningitis cocci polysaccharide and the Y group meningitis cocci polysaccharide, can find that still above-mentioned first and second is described to the immunogenic enhancement effect of pertussis antigen in combined vaccine;
Four, the inventor finds, when epidemic encephalitis, whooping cough and antigen of hepatitis B virus are mixed with epidemic encephalitis-whooping cough-hepatitis B combined vaccine, except the immunogenicity of above-mentioned enhancing pertussis antigen, also can strengthen the immunogenicity of antigen of hepatitis B virus;
Five, the inventor finds, when epidemic encephalitis, whooping cough and inactivated poliovirus are mixed with the grey combined vaccine of epidemic encephalitis-whooping cough-ridge, except the immunogenicity of above-mentioned enhancing pertussis antigen, also can strengthen the immunogenicity of Polio virus antigen;
Six, the inventor finds, when epidemic encephalitis, whooping cough, antigen of hepatitis B virus and inactivated poliovirus are mixed with the grey combined vaccine of epidemic encephalitis-whooping cough-hepatitis B-ridge, except above-mentioned enhancing pertussis antigen immunogenicity, also can strengthen the immunogenicity of antigen of hepatitis B virus and Polio virus antigen;
Seven, the inventor finds, epidemic encephalitis and whooping cough are mixed with epidemic encephalitis-whooping cough combined vaccine, and the immunogenicity of each antigen of epidemic encephalitis is not lowered after associating;
Eight, the inventor finds, epidemic encephalitis, whooping cough and antigen of hepatitis B virus are mixed with epidemic encephalitis-whooping cough-hepatitis B combined vaccine, and the immunogenicity of each antigen of epidemic encephalitis is not lowered after associating;
Nine, the inventor finds, epidemic encephalitis, whooping cough and inactivated poliovirus psma ligand are made epidemic encephalitis-whooping cough-ridge ash combined vaccine, and the immunogenicity of each antigen of epidemic encephalitis is not lowered after associating;
Ten, the inventor finds, epidemic encephalitis, whooping cough, antigen of hepatitis B virus and inactivated poliovirus psma ligand are made epidemic encephalitis-whooping cough-hepatitis B-ridge ash combined vaccine, and the immunogenicity of each antigen of epidemic encephalitis is not lowered after associating;
The 11, the inventor finds, the immunogenicity that epidemic encephalitis, whooping cough, antigen of hepatitis B virus and inactivated poliovirus antigen is mixed with respectively epidemic encephalitis-whooping cough combined vaccine, epidemic encephalitis-whooping cough-hepatitis B combined vaccine, epidemic encephalitis-whooping cough-ridge ash combined vaccine, epidemic encephalitis-whooping cough-hepatitis B-each antigen of ridge ash combined vaccine is not disturbed to each other.
It is emphasized that, the present invention is not to be that epidemic encephalitis, whooping cough, antigen of hepatitis B virus and inactivated poliovirus antigen are mixed into respectively epidemic encephalitis-whooping cough combined vaccine, epidemic encephalitis-whooping cough-hepatitis B combined vaccine, epidemic encephalitis-whooping cough-hepatitis B-ridge ash combined vaccine simply, but has consisted of core content of the present invention according to above-mentioned 11 independent discoveries.
Combined vaccine of the present invention can reduce immune pin, reduces immune cost, increase the acceptability of vaccine, thereby enlarges Immunization coverage rate.
The invention provides and derive from the capsular polysaccharide in A, C, W135, the Y group meningitis cocci and derive from B group meningitis cocci outer membrane protein composite and combined vaccine that white hundred broken compositions form.Described polysaccharide is present in the combined vaccine with separate state or with coupling state.Described polysaccharide can be with any single composition among A, C, W135, the Y group, the perhaps various combination of two compositions, and the perhaps various combination of three compositions, perhaps the various combination of four compositions is present in the combined vaccine.Described B group meningitis cocci outer membrane protein composite is 1 valency, divalent or the multivalence Outer membrane protein antigen that derives from B group meningitis cocci different shaped bacterial strain.Described white hundred broken compositions are present in the combined vaccine with full cell white hundred broken compositions or acellular white hundred broken compositions.
The invention provides to derive from the capsular polysaccharide in A, C, W135, the Y group meningitis cocci and derive from the outer membrane protein composite of B group meningitis cocci and derive from white hundred and break the combined vaccine that compositions form.Described polysaccharide is any single type in A, C, W135, the Y sero-group type, the perhaps various combination of two types, and the perhaps various combination of three types, perhaps the various combination of four types is present in the combined vaccine.Described outer membrane protein composite is any single type in the B sero-group type, the perhaps various combination of two types, and the perhaps various combination of three types, perhaps four types, perhaps the various combination of a plurality of types is present in the combined vaccine.Described white hundred broken compositions are present in the combined vaccine with full cell white hundred broken compositions or acellular white hundred broken compositions.
The invention provides and derive from capsular polysaccharide or the outer membrane protein in A, B, C, W135, the Y group meningitis cocci and derive from the combined vaccine that white hundred broken compositions form.Described polysaccharide is present in the combined vaccine with separate state or with coupling state.Described polysaccharide or outer membrane protein be in A, B, C, W135, the Y group any single composition as polysaccharide, all the other types as outer membrane protein, perhaps two compositions are that polysaccharide, all the other types are outer membrane protein, and perhaps three compositions are that polysaccharide, all the other types are that outer membrane protein or four compositions are that polysaccharide, all the other types are that the various combination of outer membrane protein is present in the combined vaccine.Described white hundred broken compositions are present in the combined vaccine with full cell white hundred broken compositions or acellular white hundred broken compositions.
Meningococcus outer membrane protein of the present invention comprises following hypotype, P1.2, P1.2.5, P1.4, P1.5, P1.5.2, P1.5c, P1.5c.10, P1.7.16, P1.7.16b, P1.9, P1.15, P1.9.15, P1.12.13, P1.13, P1.14, P1.21.16, P1.22.14.
Any in cross reacting material (CRM9, CRM197) in the preferred tetanus toxoid of the carrier protein of polysaccharide coupling of the present invention (TT), diphtheria toxoid (DT), the sudden change diphtheria toxin, diphtherotoxin, DT-Pa (PT), OMV matter complex (OMP), epidemic encephalitis 64K outer membrane protein, hemophilus influenza P1, P2, P4, P5, P6 outer membrane protein, adhesin, Recombinant pseudomonas aeruginosa exotoxin A (rEPA), albumin, the blue albumen of spoon.
Self-existent capsular polysaccharide antigen dose is each type 1-100 μ g in the combined vaccine of the present invention, preferred 5-80 μ g, more preferably 10-60 μ g, most preferably 30-50 μ g.Coupling polysaccharide antigen dosage is each type 0.1-50 μ g, preferred 0.5-30 μ g, more preferably 1-20 μ g, most preferably 1-10 μ g.Outer membrane protein antigen dosage is each type 1-100 μ g, preferred 5-80 μ g, most preferably 10-50 μ g.
Combined vaccine of the present invention also can comprise the adjuvant composition, comprises aluminium adjuvant, such as aluminium hydroxide, aluminum phosphate, aluminum sulfate etc.; Oil-in-water or bacteria cell wall composition are such as MF59, SAE, RAS etc.; The saponin adjuvant is such as Quil A, QS-21.Bacteria lipopolysaccharide or synthetic lipoid A adjuvant; Cytokine is such as interleukin, interferon, colony stimulating factor, tumor necrosis factor, costimulation molecules B7-1, B7-2 etc.; Toxin subunit class adjuvant is such as cholera toxin and subunit, pertussis toxin, PT, E.coli LT (LT) etc.
In the combined vaccine of the present invention, the vaccine dosage form comprises a kind of in liquid dosage form, freeze-dried formulation, capsule formulation, tablet, the pill, and preferred dosage form is liquid dosage form, freeze-dried formulation, capsule formulation.Can also be that partial elements is that a kind of dosage form, partial elements are another dosage form in the combined vaccine, preferred version is that partial elements is that a kind of dosage form, partial elements are another dosage form, use after the associating, more preferably scheme is that coupling or non-coupling polysaccharide are that freeze-dried formulation, DTP and/or outer membrane protein composition are liquid dosage form, in use, by liquid composition dissolving lyophilizing composition, combined immunization.
Combined vaccine route of inoculation of the present invention comprises intramuscular injection, subcutaneous injection, intradermal injection, oral, also comprises oral cavity, nasal cavity, anus, vaginal mucosa approach.
The specific embodiment
The present invention can further understand by following embodiment, and described embodiment has selected several preferred embodiments, only shows the present invention for better, but not summary of the invention is limited.
Embodiment
Embodiment 1
A group's epidemic encephalitis polysaccharide+DTP quadruple vaccine (vaccine 1)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation A group meningitis cocci polysaccharide vaccine and absorption white hundred broken combined vaccines, use with immunity after adsorbing white hundred broken combined vaccine dilution A group meningitis cocci polysaccharide vaccines.Every dosage contains 30 μ g A group meningitis cocci polysaccharide, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 2
A group's epidemic encephalitis polysaccharide+DTPa quadruple vaccine (vaccine 2)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation A group meningitis cocci polysaccharide vaccine and absorption acellular white hundred broken combined vaccines, use with immunity after adsorbing acellular white hundred broken combined vaccine dilution A group meningitis cocci polysaccharide vaccines.Every dosage contains 30 μ g A group meningitis cocci polysaccharide, and acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 3
A+C group's epidemic encephalitis polysaccharide+DTP pentavaccine (vaccine 3)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption white hundred broken combined vaccines, by pharmacopeia requirement preparation A+C group epidemic encephalitis polysaccharide vaccine, use to adsorb white hundred broken combined vaccine dilution A+C group epidemic encephalitis polysaccharide vaccine immunity.Every dosage contains 50 μ g A group meningitis cocci polysaccharide, contains 50 μ g C group meningitis cocci polysaccharide, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 4
A+C group's epidemic encephalitis polysaccharide+DTPa pentavaccine (vaccine 4)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption acellular white hundred broken combined vaccines, by pharmacopeia requirement preparation A+C group epidemic encephalitis polysaccharide vaccine, use to adsorb acellular white hundred broken combined vaccine dilution A+C group epidemic encephalitis polysaccharide vaccine immunity.Every dosage contains 50 μ gA group meningitis cocci polysaccharide, contains 50 μ g C group meningitis cocci polysaccharide, and acellular white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 5
ACW135Y group's epidemic encephalitis polysaccharide+DTP seven vaccines (vaccine 5)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption white hundred broken combined vaccines, by pharmacopeia requirement preparation ACW135Y group epidemic encephalitis polysaccharide vaccine, use to adsorb white hundred broken combined vaccine dilution ACW135Y group epidemic encephalitis polysaccharide vaccine immunity.Every dosage contains 50 μ g A group meningitis cocci polysaccharide, contains 50 μ g C group meningitis cocci polysaccharide, contains 50 μ g W135 group meningitis cocci polysaccharide, contains 50 μ g Y group meningitis cocci polysaccharide, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 6
ACW135Y group's epidemic encephalitis polysaccharide+DTPa seven vaccines (vaccine 6)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption acellular white hundred broken combined vaccines, by pharmacopeia requirement preparation ACW135Y group epidemic encephalitis polysaccharide vaccine, use to adsorb acellular white hundred broken combined vaccine dilution ACW135Y group epidemic encephalitis polysaccharide vaccine immunity.Every dosage contains 50 μ g A group meningitis cocci polysaccharide, contain 50 μ g C group meningitis cocci polysaccharide, contain 50 μ g W135 group meningitis cocci polysaccharide, contain 50 μ g Y group meningitis cocci polysaccharide, acellular white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 7
A group's epidemic encephalitis combined vaccine+DTP quadruple vaccine (vaccine 7)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption white hundred broken combined vaccines, prepare A group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, use with immunity after adsorbing white hundred broken combined vaccine dilution A group epidemic encephalitis combined vaccines.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 8
A group's epidemic encephalitis combined vaccine+DTPa quadruple vaccine (vaccine 8)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption acellular white hundred broken combined vaccines, prepare A group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, use with immunity after adsorbing acellular white hundred broken combined vaccine dilution A group epidemic encephalitis combined vaccines.Every dosage contains 5-10 μ gA group meningitis cocci polysaccharide antigen, and acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 9
A+C group's epidemic encephalitis combined vaccine+DTP pentavaccine (vaccine 9)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption white hundred broken combined vaccines, prepare A group and C group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, use with immunity after adsorbing white hundred broken combined vaccine dilution A groups and C group's epidemic encephalitis combined vaccine.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contains 5-10 μ gC group meningitis cocci polysaccharide antigen, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 10
A+C group's epidemic encephalitis combined vaccine+DTPa pentavaccine (vaccine 10)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption acellular white hundred broken combined vaccines, prepare A group and C group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, use with immunity after adsorbing acellular white hundred broken combined vaccine dilution A groups and C group's epidemic encephalitis combined vaccine.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contains 5-10 μ g C group meningitis cocci polysaccharide antigen, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 11
A+B+C group's epidemic encephalitis combined vaccine+DTP hexavaccine (vaccine 11)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption white hundred broken combined vaccines, prepare A group, B group, C group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, B group's epidemic encephalitis capsular polysaccharide can through chemical modification, use with immunity after adsorbing white hundred broken combined vaccine dilution A group, B group and C group's epidemic encephalitis combined vaccines.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contains 5-10 μ g B group meningitis cocci polysaccharide antigen, contains 5-10 μ g C group meningitis cocci polysaccharide antigen, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 12
A+B+C group's epidemic encephalitis combined vaccine+DTPa hexavaccine (vaccine 12)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption acellular white hundred broken combined vaccines, prepare A group, B group, C group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, B group's epidemic encephalitis capsular polysaccharide can through chemical modification, use with immunity after adsorbing white hundred broken combined vaccine dilution A group, B group and C group's epidemic encephalitis combined vaccines.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contains 5-10 μ g B group meningitis cocci polysaccharide antigen, contains 5-10 μ g C group meningitis cocci polysaccharide antigen, and acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 13
ACW135Y group's epidemic encephalitis combined vaccine+DTP seven vaccines (vaccine 13)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption white hundred broken combined vaccines, prepare A group, C group, W135 group and Y group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, use with immunity after adsorbing white hundred broken combined vaccine dilution ACW135Y group epidemic encephalitis combined vaccines.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ g W135 group meningitis cocci polysaccharide antigen, contain 5-10 μ g Y group meningitis cocci polysaccharide antigen, white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 14
ACW135Y group's epidemic encephalitis combined vaccine+DTPa seven vaccines (vaccine 14)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption acellular white hundred broken combined vaccines, prepare A group, C group, W135 group and Y group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, use with immunity after adsorbing acellular white hundred broken combined vaccine dilution ACW135Y group epidemic encephalitis combined vaccines.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ g W135 group meningitis cocci polysaccharide antigen, contain 5-10 μ g Y group meningitis cocci polysaccharide antigen, acellular white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 15
ABCW135Y group's epidemic encephalitis combined vaccine+DTP eight vaccines (vaccine 15)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption white hundred broken combined vaccines, prepare A group, B group, C group, W135 group, Y group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, B group's epidemic encephalitis capsular polysaccharide can through chemical modification, use with immunity after adsorbing white hundred broken combined vaccine dilution A groups, B group, C group, W135 group and Y group's epidemic encephalitis combined vaccine.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g B group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ g W135 group meningitis cocci polysaccharide antigen, contain 5-10 μ g Y group meningitis cocci polysaccharide antigen, white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 16
ABCW135Y group's epidemic encephalitis combined vaccine+DTPa eight vaccines (vaccine 16)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption acellular white hundred broken combined vaccines, prepare A group, B group, C group, W135 group, Y group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, B group's epidemic encephalitis capsular polysaccharide can through chemical modification, use with immunity after adsorbing acellular white hundred broken combined vaccine dilution A groups, B group, C group, W135 group and Y group's epidemic encephalitis combined vaccine.Every dosage contains 5-10 μ gA group meningitis cocci polysaccharide antigen, contain 5-10 μ g B group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ g W135 group meningitis cocci polysaccharide antigen, contain 5-10 μ g Y group meningitis cocci polysaccharide antigen, acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 17
A group's epidemic encephalitis polysaccharide+DTP quadruple vaccine (vaccine 17)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparations A group meningitis cocci polysaccharide and white hundred broken each component, add or do not add adjuvant, take lactose as freeze drying protectant, the preparation freeze-dried formulation.Every dosage contains 30 μ g A group meningitis cocci polysaccharide, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 18
A group's epidemic encephalitis polysaccharide+DTPa quadruple vaccine (vaccine 18)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparations A group meningitis cocci polysaccharide and white hundred broken each component, add or do not add adjuvant, take lactose as freeze drying protectant, the preparation freeze-dried formulation.Every dosage contains 30 μ g A group meningitis cocci polysaccharide, and acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 19
A+C group's epidemic encephalitis polysaccharide+DTP pentavaccine (vaccine 19)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparations A group meningitis cocci polysaccharide, C group meningitis cocci polysaccharide and white hundred broken each component, add or do not add adjuvant, take lactose as freeze drying protectant, the preparation freeze-dried formulation.Every dosage contains 50 μ g A group meningitis cocci polysaccharide, contains 50 μ g C group meningitis cocci polysaccharide, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 20
A+C group's epidemic encephalitis polysaccharide+DTPa pentavaccine (vaccine 20)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparations A group meningitis cocci polysaccharide, C group meningitis cocci polysaccharide and white hundred broken each component, add or do not add adjuvant, take lactose as freeze drying protectant, the preparation freeze-dried formulation.Every dosage contains 50 μ g A group meningitis cocci polysaccharide, contains 50 μ g C group meningitis cocci polysaccharide, and acellular white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 21
ACW135Y group's epidemic encephalitis polysaccharide+DTP seven vaccines (vaccine 21)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation A group meningitis cocci polysaccharide, C group meningitis cocci polysaccharide, W135 group meningitis cocci polysaccharide, Y group meningitis cocci polysaccharide and white hundred broken each component; add or do not add adjuvant; take lactose as freeze drying protectant, the preparation freeze-dried formulation.Every dosage contains 50 μ g A group meningitis cocci polysaccharide, contains 50 μ g C group meningitis cocci polysaccharide, contains 50 μ g W135 group meningitis cocci polysaccharide, contains 50 μ g Y group meningitis cocci polysaccharide, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 22
ACW135Y group's epidemic encephalitis polysaccharide+DTPa seven vaccines (vaccine 22)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation A group meningitis cocci polysaccharide, C group meningitis cocci polysaccharide, W135 group meningitis cocci polysaccharide, Y group meningitis cocci polysaccharide and white hundred broken each component; add or do not add adjuvant; take lactose as freeze drying protectant, the preparation freeze-dried formulation.Every dosage contains 50 μ g A group meningitis cocci polysaccharide, contain 50 μ g C group meningitis cocci polysaccharide, contain 50 μ g W135 group meningitis cocci polysaccharide, contain 50 μ g Y group meningitis cocci polysaccharide, acellular white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 23
A group's epidemic encephalitis combined vaccine+DTP quadruple vaccine (vaccine 23)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component, prepare A group's epidemic encephalitis conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, white hundred broken components and A group's epidemic encephalitis conjugate are mixed, add adjuvant, be prepared as A group's epidemic encephalitis combined vaccine+DTP quadruple vaccine.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 24
A group's epidemic encephalitis combined vaccine+DTP quadruple vaccine (vaccine 24)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component; prepare A group's epidemic encephalitis conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method; white hundred broken components and A group's epidemic encephalitis conjugate are mixed; add adjuvant; take lactose as freeze drying protectant, lyophilizing is prepared as A group's epidemic encephalitis combined vaccine+DTP quadruple vaccine.Every dosage contains 5-10 μ gA group meningitis cocci polysaccharide antigen, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 25
A group's epidemic encephalitis combined vaccine+DTPa quadruple vaccine (vaccine 25)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component, prepare A group's epidemic encephalitis conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, white hundred broken components and A group's epidemic encephalitis conjugate are mixed, add adjuvant, be prepared as A group's epidemic encephalitis combined vaccine+DTP quadruple vaccine.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, and acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 26
A group's epidemic encephalitis combined vaccine+DTPa quadruple vaccine (vaccine 26)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component; prepare A group's epidemic encephalitis conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method; white hundred broken components and A group's epidemic encephalitis conjugate are mixed; add adjuvant; take lactose as freeze drying protectant, lyophilizing is prepared as A group's epidemic encephalitis combined vaccine+DTP quadruple vaccine.Every dosage contains 5-10 μ gA group meningitis cocci polysaccharide antigen, and acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 27
A+C group's epidemic encephalitis combined vaccine+DTP pentavaccine (vaccine 27)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component, prepare A group's epidemic encephalitis conjugate and C group's conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, white hundred broken components, A group's epidemic encephalitis conjugate and C group's epidemic encephalitis conjugate are mixed, add adjuvant, be prepared as A+C group's epidemic encephalitis combined vaccine+DTP pentavaccine.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contains 5-10 μ g C group meningitis cocci polysaccharide antigen, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 28
A+C group's epidemic encephalitis combined vaccine+DTP pentavaccine (vaccine 28)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component; prepare A group's epidemic encephalitis conjugate and C group's epidemic encephalitis conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method; white hundred broken components and A group's epidemic encephalitis conjugate are mixed; add adjuvant; take lactose as freeze drying protectant, lyophilizing is prepared as A+C group's epidemic encephalitis combined vaccine+DTP pentavaccine.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contains 5-10 μ g C group meningitis cocci polysaccharide antigen, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 29
A+C group's epidemic encephalitis combined vaccine+DTPa pentavaccine (vaccine 29)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component, prepare A group's epidemic encephalitis conjugate and C group's conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, white hundred broken components, A group's epidemic encephalitis conjugate and C group's epidemic encephalitis conjugate are mixed, add adjuvant, be prepared as A+C group's epidemic encephalitis combined vaccine+DTPa pentavaccine.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contains 5-10 μ g C group meningitis cocci polysaccharide antigen, and acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 30
A+C group's epidemic encephalitis combined vaccine+DTPa pentavaccine (vaccine 30)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component; prepare A group's epidemic encephalitis conjugate and C group's epidemic encephalitis conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method; white hundred broken components and A group's epidemic encephalitis conjugate are mixed; add adjuvant; take lactose as freeze drying protectant, lyophilizing is prepared as A+C group's epidemic encephalitis combined vaccine+DTPa pentavaccine.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contains 5-10 μ g C group meningitis cocci polysaccharide antigen, and acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 31
A+B+C group's epidemic encephalitis combined vaccine+DTP hexavaccine (vaccine 31)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component, prepare A group's epidemic encephalitis conjugate, B group's epidemic encephalitis conjugate and C group's conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, B group's capsular polysaccharide can be through modifying, white hundred broken components, A group's epidemic encephalitis conjugate, B group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate are mixed, add adjuvant, be prepared as A+B+C group's epidemic encephalitis combined vaccine+DTP hexavaccine.Every dosage contains 5-10 μ gA group meningitis cocci polysaccharide antigen, contains 5-10 μ g B group meningitis cocci polysaccharide antigen, contains 5-10 μ g C group meningitis cocci polysaccharide antigen, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 32
A+B+C group's epidemic encephalitis combined vaccine+DTP hexavaccine (vaccine 32)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component; prepare A group's epidemic encephalitis conjugate, B group's epidemic encephalitis conjugate and C group's conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method; B group's capsular polysaccharide can be through modifying; white hundred broken components, A group's epidemic encephalitis conjugate, B group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate are mixed; add adjuvant; take lactose as freeze drying protectant, lyophilizing is prepared as A+B+C group's epidemic encephalitis combined vaccine+DTP hexavaccine.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contains 5-10 μ g B group meningitis cocci polysaccharide antigen, contains 5-10 μ g C group meningitis cocci polysaccharide antigen, and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 33
A+B+C group's epidemic encephalitis combined vaccine+DTPa hexavaccine (vaccine 33)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation acellular white hundred broken each component, prepare A group's epidemic encephalitis conjugate, B group's epidemic encephalitis conjugate and C group's conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, B group's capsular polysaccharide can be through modifying, acellular white hundred broken components, A group's epidemic encephalitis conjugate, B group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate are mixed, add adjuvant, be prepared as A+B+C group's epidemic encephalitis combined vaccine+DTP hexavaccine.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contains 5-10 μ g B group meningitis cocci polysaccharide antigen, contains 5-10 μ g C group meningitis cocci polysaccharide antigen, and acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 34
A+B+C group's epidemic encephalitis combined vaccine+DTPa hexavaccine (vaccine 34)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation acellular white hundred broken each component; prepare A group's epidemic encephalitis conjugate, B group's epidemic encephalitis conjugate and C group's conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method; B group's capsular polysaccharide can be through modifying; acellular white hundred broken components, A group's epidemic encephalitis conjugate, B group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate are mixed; add adjuvant; take lactose as freeze drying protectant, lyophilizing is prepared as A+B+C group's epidemic encephalitis combined vaccine+DTP hexavaccine.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contains 5-10 μ g B group meningitis cocci polysaccharide antigen, contains 5-10 μ g C group meningitis cocci polysaccharide antigen, and acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 35
ACW135Y group's epidemic encephalitis combined vaccine+DTP seven vaccines (vaccine 35)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component, prepare A group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate, W135 group's epidemic encephalitis conjugate and Y group's epidemic encephalitis conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, white hundred broken components, A group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate, W135 group's epidemic encephalitis conjugate, Y group's epidemic encephalitis conjugate are mixed, add adjuvant, be prepared as ACW135Y group's epidemic encephalitis combined vaccine+DTP seven vaccines.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ g W135 group meningitis cocci polysaccharide antigen, contain 5-10 μ g Y group meningitis cocci polysaccharide antigen, white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 36
ACW135Y group's epidemic encephalitis combined vaccine+DTP seven vaccines (vaccine 36)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component; prepare A group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate, W135 group's epidemic encephalitis conjugate and Y group's epidemic encephalitis conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method; white hundred broken components, A group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate, W135 group's epidemic encephalitis conjugate, Y group's epidemic encephalitis conjugate are mixed; add adjuvant; take lactose as freeze drying protectant, lyophilizing is prepared as ACW135Y group's epidemic encephalitis combined vaccine+DTP seven vaccines.Every dosage contains 5-10 μ gA group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ g W135 group meningitis cocci polysaccharide antigen, contain 5-10 μ g Y group meningitis cocci polysaccharide antigen, white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 37
ACW135Y group's epidemic encephalitis combined vaccine+DTPa seven vaccines (vaccine 37)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component, prepare A group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate, W135 group's epidemic encephalitis conjugate and Y group's epidemic encephalitis conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, white hundred broken components, A group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate, W135 group's epidemic encephalitis conjugate, Y group's epidemic encephalitis conjugate are mixed, add adjuvant, be prepared as ACW135Y group's epidemic encephalitis combined vaccine+DTPa seven vaccines.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ g W135 group meningitis cocci polysaccharide antigen, contain 5-10 μ g Y group meningitis cocci polysaccharide antigen, acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 38
ACW135Y group's epidemic encephalitis combined vaccine+DTPa seven vaccines (vaccine 38)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component; prepare A group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate, W135 group's epidemic encephalitis conjugate and Y group's epidemic encephalitis conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method; white hundred broken components, A group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate, W135 group's epidemic encephalitis conjugate, Y group's epidemic encephalitis conjugate are mixed; add adjuvant; take lactose as freeze drying protectant, lyophilizing is prepared as ACW135Y group's epidemic encephalitis combined vaccine+DTPa seven vaccines.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ g W135 group meningitis cocci polysaccharide antigen, contain 5-10 μ g Y group meningitis cocci polysaccharide antigen, acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 39
ABCW135Y group's epidemic encephalitis combined vaccine+DTP eight vaccines (vaccine 39)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component, with cyanogen bromide-activated, the ADH derivatization method prepares A group's epidemic encephalitis conjugate, B group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate, W135 group's epidemic encephalitis conjugate and Y group's epidemic encephalitis conjugate (or ammonia reducing process), B group's epidemic encephalitis capsular polysaccharide can be modified, with white hundred broken components, A group's epidemic encephalitis conjugate, B group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate, W135 group's epidemic encephalitis conjugate, Y group's epidemic encephalitis conjugate mixes, add adjuvant, be prepared as ABCW135Y group's epidemic encephalitis combined vaccine+DTP eight vaccines.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g B group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ gW135 group meningitis cocci polysaccharide antigen, contain 5-10 μ gY group meningitis cocci polysaccharide antigen, white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 40
ABCW135Y group's epidemic encephalitis combined vaccine+DTP eight vaccines (vaccine 40)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component; with cyanogen bromide-activated; the ADH derivatization method prepares A group's epidemic encephalitis conjugate; B group's epidemic encephalitis conjugate; C group's epidemic encephalitis conjugate; W135 group's epidemic encephalitis conjugate and Y group's epidemic encephalitis conjugate (or ammonia reducing process); with white hundred broken components; A group's epidemic encephalitis conjugate; B group's epidemic encephalitis conjugate; C group's epidemic encephalitis conjugate; W135 group's epidemic encephalitis conjugate; Y group's epidemic encephalitis conjugate mixes; add adjuvant; take lactose as freeze drying protectant, lyophilizing is prepared as ABCW135Y group's epidemic encephalitis combined vaccine+DTP eight vaccines.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g B group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ g W135 group meningitis cocci polysaccharide antigen, contain 5-10 μ g Y group meningitis cocci polysaccharide antigen, white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 41
ABCW135Y group's epidemic encephalitis combined vaccine+DTPa eight vaccines (vaccine 41)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component, prepare A group's epidemic encephalitis conjugate, B group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate, W135 group's epidemic encephalitis conjugate and Y group's epidemic encephalitis conjugate (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, white hundred broken components, A group's epidemic encephalitis conjugate, B group's epidemic encephalitis conjugate, C group's epidemic encephalitis conjugate, W135 group's epidemic encephalitis conjugate, Y group's epidemic encephalitis conjugate are mixed, add adjuvant, be prepared as ABCW135Y group's epidemic encephalitis combined vaccine+DTPa eight vaccines.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g B group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ g W135 group meningitis cocci polysaccharide antigen, contain 5-10 μ gY group meningitis cocci polysaccharide antigen, acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 42
ABCW135Y group's epidemic encephalitis combined vaccine+DTPa eight vaccines (vaccine 42)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation white hundred broken each component; with cyanogen bromide-activated; the ADH derivatization method prepares A group's epidemic encephalitis conjugate; B group's epidemic encephalitis conjugate; C group's epidemic encephalitis conjugate; W135 group's epidemic encephalitis conjugate and Y group's epidemic encephalitis conjugate (or ammonia reducing process); with white hundred broken components; A group's epidemic encephalitis conjugate; B group's epidemic encephalitis conjugate; C group's epidemic encephalitis conjugate; W135 group's epidemic encephalitis conjugate; Y group's epidemic encephalitis conjugate mixes; add adjuvant; take lactose as freeze drying protectant, lyophilizing is prepared as ABCW135Y group's epidemic encephalitis combined vaccine+DTPa eight vaccines.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g B group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ gW135 group meningitis cocci polysaccharide antigen, contain 5-10 μ g Y group meningitis cocci polysaccharide antigen, acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
Embodiment 43
ABC group's epidemic encephalitis+DTP hexavaccine (vaccine 43)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption white hundred broken combined vaccines, prepare A group and C group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, prepare OMV complex (OMV) with ultrafiltration, be aided with adjuvant, be prepared into liquid or lyophilized formulations.Also above-mentioned composition can be prepared respectively, mix co-inoculation before using.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contains 5-10 μ gC group meningitis cocci polysaccharide antigen, contains 30-50 μ g OMV (OMV), and white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.Show that through the animal potency test immunogenicity of pertussis antigen is enhanced, each antigen of combined vaccine is noiseless to each other.
Embodiment 44
ABC group's epidemic encephalitis+DTPa hexavaccine (vaccine 44)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption acellular white hundred broken combined vaccines, prepare A group and C group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, prepare OMV complex (OMV) with ultrafiltration, be aided with adjuvant, be prepared into liquid or lyophilized formulations.Also above-mentioned composition can be prepared respectively, mix co-inoculation before using.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 30-50 μ g OMV (OMV), acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.Show that through the animal potency test immunogenicity of pertussis antigen is enhanced, each antigen of combined vaccine is noiseless to each other.
Embodiment 45
ABCW135Y group epidemic encephalitis+DTP eight vaccines (vaccine 45)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption white hundred broken combined vaccines, prepare A group, C group, W135 group and Y group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, prepare OMV complex (OMV) with ultrafiltration, be aided with adjuvant, be prepared into liquid or lyophilized formulations.Also above-mentioned composition can be prepared respectively, mix co-inoculation before using.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ g W135 group meningitis cocci polysaccharide antigen, contain 5-10 μ g Y group meningitis cocci polysaccharide antigen, contain 30-50 μ g OMV (OMV), white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.Show that through the animal potency test immunogenicity of pertussis antigen is enhanced, each antigen of combined vaccine is noiseless to each other.
Embodiment 46
ABCW135Y group epidemic encephalitis+DTPa eight vaccines (vaccine 46)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption acellular white hundred broken combined vaccines, prepare A group, C group, W135 group and Y group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, prepare OMV complex (OMV) with ultrafiltration, be aided with adjuvant, be prepared into liquid or lyophilized formulations.Also above-mentioned composition can be prepared respectively, mix co-inoculation before using.Every dosage contains 5-10 μ gA group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ gW135 group meningitis cocci polysaccharide antigen, contain 5-10 μ gY group meningitis cocci polysaccharide antigen, contain 30-50 μ g OMV (OMV), acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.Show that through the animal potency test immunogenicity of pertussis antigen is enhanced, each antigen of combined vaccine is noiseless to each other.
Embodiment 47
Other dosage forms of combined vaccine (vaccine 47)
After various epidemic encephalitis polysaccharide composition, the lyophilizing of DTP composition, add the adjuvants such as direct-connected starch, lactose, also can add the described adjuvant of description, be prepared into liquid, other outer dosage forms of freeze-dried formulation.
Embodiment 48
ABC group's epidemic encephalitis+DTPa+ hepatitis B seven vaccines (vaccine 48)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption acellular white hundred broken combined vaccine and hepatitis B virus vaccines, prepare A group and C group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, prepare OMV complex (OMV) with ultrafiltration, be aided with adjuvant, be prepared into liquid or lyophilized formulations.Also above-mentioned composition can be prepared respectively, mix co-inoculation before using.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 30-50 μ g OMV (OMV), 5-10 μ g hepatitis B virus surface antigen, acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.Show that through the animal potency test immunogenicity of pertussis antigen is enhanced, the immunogenicity of antigen of hepatitis B virus is enhanced, and each antigen of combined vaccine is noiseless to each other.
Embodiment 49
ABC group's epidemic encephalitis+DTPa+ deactivation ridge ash seven vaccines (vaccine 49)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption acellular white hundred broken combined vaccines; Make vertification regulation according to the WHO PKV and prepare deactivation purification Polio virus vaccine; Prepare A group and C group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, prepare OMV complex (OMV) with ultrafiltration, be aided with adjuvant, be prepared into liquid or lyophilized formulations.Also above-mentioned composition can be prepared respectively, mix co-inoculation before using.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 30-50 μ g OMV (OMV), contain poliomyelitis I, II, III type virus antigen contains 10-200IU, acellular white hundred broken dosage are by the acellular white hundred broken combined vaccines regulations of absorption in the pharmacopeia.Show that through the animal potency test immunogenicity of pertussis antigen is enhanced, the immunogenicity of Polio virus antigen is enhanced, and each antigen of combined vaccine is noiseless to each other.
Embodiment 50
ABC group's epidemic encephalitis+DTPa+ hepatitis B+deactivation poliomyelitis eight vaccines (vaccine 50)
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption acellular white hundred broken combined vaccine and hepatitis B virus vaccines; Make vertification regulation according to the WHO PKV and prepare deactivation purification Polio virus vaccine; Prepare A group and C group's epidemic encephalitis combined vaccine (or ammonia reducing process) with cyanogen bromide-activated, ADH derivatization method, prepare OMV complex (OMV) with ultrafiltration, be aided with adjuvant, be prepared into liquid or lyophilized formulations.Also above-mentioned composition can be prepared respectively, mix co-inoculation before using.Every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 30-50 μ g OMV (OMV), 5-10 μ g hepatitis B virus surface antigen, contain poliomyelitis I, II, III type virus antigen contains 10-200IU, acellular white hundred broken dosage are by the acellular white hundred broken combined vaccines regulations of absorption in the pharmacopeia.Show that through the animal potency test immunogenicity of pertussis antigen is enhanced, the immunogenicity of hepatitis B antigen is enhanced, and the immunogenicity of Polio virus antigen is enhanced, and each antigen of combined vaccine is noiseless to each other.
Experimental example
Embodiment 1
Antibody response situation behind the combined vaccine immune mouse
According to three ones of Pharmacopoeias of People's Republic of China (version in 2005) preparation absorption acellular white hundred broken combined vaccine and hepatitis B virus vaccines; Make vertification regulation according to the WHO PKV and prepare deactivation purification Polio virus vaccine; According to embodiment 34,38 preparation combined vaccines.With the NIH mice of the 1/10 immune 14-18 gram of human dosage, immune 3 pins, in 2 weeks of immune interval, immunization route is subcutaneous, in 1 week after the 3rd pin immunity, each antibody titer is measured in blood sampling.Assay method is selected indirect ELISA, and envelope antigen is selected each the univalent vaccine composition that does not add adjuvant.Bearing performance is that the each component immunogenicity is enhanced, and measurement result sees Table 1.
Embodiment 2
Combined vaccine each component immunogenicity influences each other
Adopt animal experiment to assess combined vaccine provided by the invention immunogenicity of each component after associating effect that influences each other, the immunogenicity detection method of each vaccine component is as follows in the combined vaccine:
Vaccine of epidemic menigitis immunogenicity detection method: use 1/4 dosage, by 0,14 day program immunity mice two pin, subcutaneous vaccination, in blood sampling in 28 days, separation of serum was measured the mice serum antibody titer with the ELISA method.
DPT vaccine immunogenicity detection method: carry out according to three ones of Pharmacopoeias of People's Republic of China (version in 2005).
Hepatitis b vaccination originality detection method: carry out according to three ones of Pharmacopoeias of People's Republic of China (version in 2005).
PKV immunogenicity detection method: in rat muscle injection combined vaccine, exempt from blood sampling in rear 21 days, separation of serum is measured neutralization and is tired.
The result shows that the immunogenicity of combined vaccine each component antigen of the present invention is not lowered after associating, namely vaccine of epidemic menigitis take B group meningitis cocci outer membrane protein as core and that comprise other group meningitis cocci coupling or non-coupling polysaccharide antigen does not have interference effect to the immunogenicity of pertussis antigen, diphtheria toxoid antigen, tetanus toxoid antigen, antigen of hepatitis B virus, poliovirus antigen.Advance-go on foot demonstration, the immunogenicity of pertussis antigen, antigen of hepatitis B virus, poliovirus antigen also is reinforced after above-mentioned associating, and result of the test sees Table 2 and table 3.
Figure S2008100875987D00261
Figure S2008100875987D00271
Figure S2008100875987D00281

Claims (9)

1. A+B+C group's epidemic encephalitis combined vaccine+DTPa hexavaccine, wherein every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g B group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
2. ACW135Y group's epidemic encephalitis combined vaccine+DTPa seven vaccines, wherein every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ g W135 group meningitis cocci polysaccharide antigen, contain 5-10 μ g Y group meningitis cocci polysaccharide antigen, acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
3. ABC group's epidemic encephalitis+DTP hexavaccine, wherein every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 30-50 μ g OMV (OMV), white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
4. ABC group's epidemic encephalitis+DTPa hexavaccine, wherein every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 30-50 μ g OMV (OMV), acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
5. ABCW135Y group epidemic encephalitis+DTP eight vaccines, wherein every dosage contains 5-10 μ gA group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ g W135 group meningitis cocci polysaccharide antigen, contain 5-10 μ g Y group meningitis cocci polysaccharide antigen, contain 30-50 μ g OMV (OMV), white hundred broken dosage are by the white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
6. ABCW135Y group epidemic encephalitis+DTPa eight vaccines, wherein every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 5-10 μ g W135 group meningitis cocci polysaccharide antigen, contain 5-10 μ g Y group meningitis cocci polysaccharide antigen, contain 30-50 μ g OMV (OMV), acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
7. ABC group's epidemic encephalitis+DTPa+ hepatitis B seven vaccines, wherein every dosage contains 5-10 μ gA group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 30-50 μ g OMV (OMV), 5-10 μ g hepatitis B virus surface antigen, acellular white hundred broken dosage are by the acellular white hundred broken combined vaccine regulations of absorption in the pharmacopeia.
8. ABC group's epidemic encephalitis+DTPa+ deactivation ridge ash seven vaccines, wherein every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 30-50 μ g OMV (OMV), contain poliomyelitis I, II, III type virus antigen contains 10-200IU, acellular white hundred broken dosage are by the acellular white hundred broken combined vaccines regulations of absorption in the pharmacopeia.
9. ABC group's epidemic encephalitis+DTPa+ hepatitis B+deactivation poliomyelitis eight vaccines, wherein every dosage contains 5-10 μ g A group meningitis cocci polysaccharide antigen, contain 5-10 μ g C group meningitis cocci polysaccharide antigen, contain 30-50 μ g OMV (OMV), 5-10 μ g hepatitis B virus surface antigen, contain poliomyelitis I, II, III type virus antigen contains 10-200IU, acellular white hundred broken dosage are by the acellular white hundred broken combined vaccines regulations of absorption in the pharmacopeia.
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