JP5637848B2 - 髄膜炎ワクチンの製剤化 - Google Patents

髄膜炎ワクチンの製剤化 Download PDF

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Publication number
JP5637848B2
JP5637848B2 JP2010510910A JP2010510910A JP5637848B2 JP 5637848 B2 JP5637848 B2 JP 5637848B2 JP 2010510910 A JP2010510910 A JP 2010510910A JP 2010510910 A JP2010510910 A JP 2010510910A JP 5637848 B2 JP5637848 B2 JP 5637848B2
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Japan
Prior art keywords
saccharide
conjugate
component
lyophilized
kit
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
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JP2010510910A
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English (en)
Japanese (ja)
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JP2010529103A (ja
JP2010529103A5 (enExample
Inventor
マリオ コントーニ,
マリオ コントーニ,
パオロ コンスタンチーノ,
パオロ コンスタンチーノ,
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ノバルティス アーゲー
ノバルティス アーゲー
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Publication of JP2010529103A5 publication Critical patent/JP2010529103A5/ja
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/102Pasteurellales, e.g. Actinobacillus, Pasteurella; Haemophilus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/095Neisseria
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/646Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505Inorganic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55566Emulsions, e.g. Freund's adjuvant, MF59
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/70Multivalent vaccine
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Virology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2010510910A 2007-06-04 2008-06-04 髄膜炎ワクチンの製剤化 Expired - Fee Related JP5637848B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US93323507P 2007-06-04 2007-06-04
US60/933,235 2007-06-04
PCT/IB2008/002121 WO2008149238A2 (en) 2007-06-04 2008-06-04 Formulation of meningitis vaccines

Publications (3)

Publication Number Publication Date
JP2010529103A JP2010529103A (ja) 2010-08-26
JP2010529103A5 JP2010529103A5 (enExample) 2011-07-21
JP5637848B2 true JP5637848B2 (ja) 2014-12-10

Family

ID=40094241

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2010510910A Expired - Fee Related JP5637848B2 (ja) 2007-06-04 2008-06-04 髄膜炎ワクチンの製剤化

Country Status (13)

Country Link
US (1) US20100203137A1 (enExample)
EP (1) EP2152302B1 (enExample)
JP (1) JP5637848B2 (enExample)
CN (1) CN101678094B (enExample)
AU (2) AU2008259423A1 (enExample)
BR (1) BRPI0811979A2 (enExample)
CA (1) CA2688268A1 (enExample)
ES (1) ES2555786T3 (enExample)
IN (1) IN2009KN04098A (enExample)
MX (1) MX2009013112A (enExample)
NZ (1) NZ581367A (enExample)
RU (1) RU2009149359A (enExample)
WO (1) WO2008149238A2 (enExample)

Families Citing this family (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001031019A2 (en) 1999-10-29 2001-05-03 Chiron Spa Neisserial antigenic peptides
PT1944371E (pt) 1998-05-01 2015-07-13 Novartis Ag Antigénios e composições da neisseria meningitidis
EP1860191A3 (en) 1999-05-19 2008-02-13 Novartis Vaccines and Diagnostics S.r.l. Combination neisserial compositions
EP1790660B1 (en) 2000-02-28 2012-06-20 Novartis Vaccines and Diagnostics S.r.l. Heterologous expression of neisserial proteins
DZ3399A1 (fr) * 2000-06-29 2002-01-03 Smithkline Beecham Biolog Composition de vaccin polyvalent
GB0118249D0 (en) 2001-07-26 2001-09-19 Chiron Spa Histidine vaccines
GB0121591D0 (en) 2001-09-06 2001-10-24 Chiron Spa Hybrid and tandem expression of neisserial proteins
MX339524B (es) 2001-10-11 2016-05-30 Wyeth Corp Composiciones inmunogenicas novedosas para la prevencion y tratamiento de enfermedad meningococica.
GB0227346D0 (en) 2002-11-22 2002-12-31 Chiron Spa 741
GB0408977D0 (en) 2004-04-22 2004-05-26 Chiron Srl Immunising against meningococcal serogroup Y using proteins
UA95237C2 (uk) 2005-06-27 2011-07-25 Ґлаксосмітклайн Байолоджікалз С.А. Імуногенна композиція
GB0524066D0 (en) 2005-11-25 2006-01-04 Chiron Srl 741 ii
ATE553774T1 (de) * 2007-10-19 2012-05-15 Novartis Ag Meningokokkenimpfstoffformulierungen
WO2009104097A2 (en) 2008-02-21 2009-08-27 Novartis Ag Meningococcal fhbp polypeptides
WO2010005735A2 (en) 2008-06-16 2010-01-14 Academia Sinica Compositions for inducing immune responses specific to globo h and ssea3 and uses thereof in cancer treatment
GB0822634D0 (en) 2008-12-11 2009-01-21 Novartis Ag Meningitis vaccines
WO2010109324A1 (en) * 2009-03-24 2010-09-30 Novartis Ag Combinations of meningococcal factor h binding protein and pneumococcal saccharide conjugates
NZ595234A (en) * 2009-03-24 2013-12-20 Novartis Ag Adjuvanting meningococcal factor h binding protein
US10478483B2 (en) 2010-06-25 2019-11-19 Glaxosmithkline Biologicals Sa Combinations of meningococcal factor H binding proteins
MX350142B (es) 2010-08-23 2017-08-28 Wyeth Llc * Formulaciones estables de antigenos rlp2086 de neisseria meningitidis.
SG187912A1 (en) 2010-09-10 2013-04-30 Wyeth Llc Non-lipidated variants of neisseria meningitidis orf2086 antigens
BR112013012626A2 (pt) * 2010-12-10 2016-07-19 Merck Sharp & Dohme formulação, composição imunogênica, e, seringa pré-carregada
IN2012MU00206A (enExample) * 2012-01-20 2013-08-09
MX372965B (es) * 2012-03-08 2020-04-01 Glaxosmithkline Biologicals Sa Formulaciones adyuvadas de vacunas de difteria, tetanos y tos ferina (dtp) de refuerzo.
KR101763625B1 (ko) 2012-03-09 2017-08-01 화이자 인코포레이티드 수막염균 조성물 및 이의 사용 방법
SA115360586B1 (ar) 2012-03-09 2017-04-12 فايزر انك تركيبات لعلاج الالتهاب السحائي البكتيري وطرق لتحضيرها
JP2015521595A (ja) 2012-06-14 2015-07-30 ノバルティス アーゲー 血清群x髄膜炎菌のためのワクチン
WO2014136064A2 (en) 2013-03-08 2014-09-12 Pfizer Inc. Immunogenic fusion polypeptides
CA2923129C (en) 2013-09-08 2020-06-09 Pfizer Inc. Neisseria meningitidis compositions and methods thereof
CN107249626A (zh) 2015-02-19 2017-10-13 辉瑞大药厂 脑膜炎奈瑟球菌组合物及其方法
PL3506935T3 (pl) 2016-09-02 2024-06-10 Sanofi Pasteur, Inc. Szczepionka przeciwko Neisseria meningitidis
PE20191107A1 (es) 2017-01-31 2019-08-26 Pfizer Composiciones de neisseria meningitidis y metodos respectivos
CA3155669A1 (en) 2019-09-27 2021-04-01 Pfizer Inc. Neisseria meningitidis compositions and methods thereof

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5153312A (en) 1990-09-28 1992-10-06 American Cyanamid Company Oligosaccharide conjugate vaccines
US5425946A (en) 1992-08-31 1995-06-20 North American Vaccine, Inc. Vaccines against group C Neisseria meningitidis
ATE212233T1 (de) 1992-08-31 2002-02-15 Baxter Healthcare Sa Impfstoffe gegen neisseria meningitidis gruppe c
GB9422096D0 (en) * 1994-11-02 1994-12-21 Biocine Spa Combined meningitis vaccine
CZ288908B6 (cs) 1995-06-23 2001-09-12 Smithkline Beecham Biologicals S. A. Kombinovaná vakcína, tato vakcína ve formě sady, způsob její výroby a její použití
US6299881B1 (en) 1997-03-24 2001-10-09 Henry M. Jackson Foundation For The Advancement Of Military Medicine Uronium salts for activating hydroxyls, carboxyls, and polysaccharides, and conjugate vaccines, immunogens, and other useful immunological reagents produced using uronium salts
DZ3399A1 (fr) 2000-06-29 2002-01-03 Smithkline Beecham Biolog Composition de vaccin polyvalent
KR100947757B1 (ko) 2001-01-23 2010-03-18 아벤티스 파스퇴르 다가 수막구균 폴리사카라이드―단백질 접합체 백신
GB0115176D0 (en) * 2001-06-20 2001-08-15 Chiron Spa Capular polysaccharide solubilisation and combination vaccines
NZ535968A (en) 2002-03-26 2006-08-31 Chiron S Modified saccharides having improved stability in water
CN101926988B (zh) * 2003-01-30 2014-06-04 诺华疫苗和诊断有限公司 抗多种脑膜炎球菌血清组的可注射性疫苗
JP4738339B2 (ja) 2003-10-02 2011-08-03 ノバルティス ヴァクシンズ アンド ダイアグノスティクス エスアールエル 複数の髄膜炎菌血清群についての液体ワクチン
GB0405787D0 (en) * 2004-03-15 2004-04-21 Chiron Srl Low dose vaccines
GB0500787D0 (en) * 2005-01-14 2005-02-23 Chiron Srl Integration of meningococcal conjugate vaccination
GB0409745D0 (en) * 2004-04-30 2004-06-09 Chiron Srl Compositions including unconjugated carrier proteins
GB0505518D0 (en) * 2005-03-17 2005-04-27 Chiron Srl Combination vaccines with whole cell pertussis antigen
CN1709505B (zh) * 2005-07-13 2010-06-16 北京绿竹生物制药有限公司 多价细菌荚膜多糖-蛋白质结合物联合疫苗
EP2308505A3 (en) * 2005-09-01 2011-11-30 Novartis Vaccines and Diagnostics GmbH Multiple vaccines including serogroup C meningococcus
GB0524066D0 (en) * 2005-11-25 2006-01-04 Chiron Srl 741 ii
ATE553774T1 (de) * 2007-10-19 2012-05-15 Novartis Ag Meningokokkenimpfstoffformulierungen

Also Published As

Publication number Publication date
BRPI0811979A2 (pt) 2014-10-21
EP2152302A2 (en) 2010-02-17
MX2009013112A (es) 2010-03-01
WO2008149238A3 (en) 2009-08-06
ES2555786T3 (es) 2016-01-08
AU2014204425B2 (en) 2015-10-29
JP2010529103A (ja) 2010-08-26
NZ581367A (en) 2012-05-25
CN101678094A (zh) 2010-03-24
CN101678094B (zh) 2014-08-27
AU2008259423A1 (en) 2008-12-11
AU2014204425A1 (en) 2014-08-07
CA2688268A1 (en) 2008-12-11
EP2152302B1 (en) 2015-10-07
US20100203137A1 (en) 2010-08-12
RU2009149359A (ru) 2011-07-20
IN2009KN04098A (enExample) 2015-08-28
WO2008149238A2 (en) 2008-12-11

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