HRP20130962T1 - Smanjenje potencijalnih iatrogenih rizika povezanih sa antigenima cjepiva - Google Patents
Smanjenje potencijalnih iatrogenih rizika povezanih sa antigenima cjepiva Download PDFInfo
- Publication number
- HRP20130962T1 HRP20130962T1 HRP20130962TT HRP20130962T HRP20130962T1 HR P20130962 T1 HRP20130962 T1 HR P20130962T1 HR P20130962T T HRP20130962T T HR P20130962TT HR P20130962 T HRP20130962 T HR P20130962T HR P20130962 T1 HRP20130962 T1 HR P20130962T1
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- Prior art keywords
- virus
- vaccine
- culture
- influenza virus
- carried out
- Prior art date
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- 229960005486 vaccine Drugs 0.000 title claims abstract 9
- 239000000427 antigen Substances 0.000 title claims abstract 7
- 102000036639 antigens Human genes 0.000 title claims abstract 7
- 108091007433 antigens Proteins 0.000 title claims abstract 7
- 230000003247 decreasing effect Effects 0.000 title 1
- 230000000642 iatrogenic effect Effects 0.000 title 1
- 238000000034 method Methods 0.000 claims abstract 12
- 244000052769 pathogen Species 0.000 claims abstract 6
- 210000004027 cell Anatomy 0.000 claims abstract 2
- 210000003501 vero cell Anatomy 0.000 claims abstract 2
- 241000700605 Viruses Species 0.000 claims 6
- 241000712461 unidentified influenza virus Species 0.000 claims 5
- 238000001514 detection method Methods 0.000 claims 3
- 230000001717 pathogenic effect Effects 0.000 claims 3
- 241000271566 Aves Species 0.000 claims 2
- 241001533384 Circovirus Species 0.000 claims 2
- 239000000463 material Substances 0.000 claims 2
- 230000003612 virological effect Effects 0.000 claims 2
- 241000701242 Adenoviridae Species 0.000 claims 1
- 241000700586 Herpesviridae Species 0.000 claims 1
- 241000701460 JC polyomavirus Species 0.000 claims 1
- 102000018697 Membrane Proteins Human genes 0.000 claims 1
- 108010052285 Membrane Proteins Proteins 0.000 claims 1
- 241001430197 Mollicutes Species 0.000 claims 1
- 208000002606 Paramyxoviridae Infections Diseases 0.000 claims 1
- 241000202347 Porcine circovirus Species 0.000 claims 1
- 241000125945 Protoparvovirus Species 0.000 claims 1
- 241000702247 Reoviridae Species 0.000 claims 1
- 108700010877 adenoviridae proteins Proteins 0.000 claims 1
- 239000001963 growth medium Substances 0.000 claims 1
- 238000003306 harvesting Methods 0.000 claims 1
- 230000000984 immunochemical effect Effects 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 102000039446 nucleic acids Human genes 0.000 claims 1
- 108020004707 nucleic acids Proteins 0.000 claims 1
- 150000007523 nucleic acids Chemical class 0.000 claims 1
- 238000004806 packaging method and process Methods 0.000 claims 1
- 238000000751 protein extraction Methods 0.000 claims 1
- 238000003908 quality control method Methods 0.000 claims 1
- 238000003757 reverse transcription PCR Methods 0.000 claims 1
- 238000000926 separation method Methods 0.000 claims 1
- 239000000758 substrate Substances 0.000 claims 1
- 230000009385 viral infection Effects 0.000 claims 1
- 238000011109 contamination Methods 0.000 abstract 1
- 210000004962 mammalian cell Anatomy 0.000 abstract 1
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
- A61K39/145—Orthomyxoviridae, e.g. influenza virus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
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- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
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- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
- C12Q1/701—Specific hybridization probes
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56983—Viruses
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
- C12N2760/00011—Details
- C12N2760/16011—Orthomyxoviridae
- C12N2760/16034—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
- C12N2760/00011—Details
- C12N2760/16011—Orthomyxoviridae
- C12N2760/16051—Methods of production or purification of viral material
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
- C12N2760/00011—Details
- C12N2760/16011—Orthomyxoviridae
- C12N2760/16111—Influenzavirus A, i.e. influenza A virus
- C12N2760/16134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
- C12N2760/00011—Details
- C12N2760/16011—Orthomyxoviridae
- C12N2760/16211—Influenzavirus B, i.e. influenza B virus
- C12N2760/16234—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/005—Assays involving biological materials from specific organisms or of a specific nature from viruses
- G01N2333/08—RNA viruses
- G01N2333/11—Orthomyxoviridae, e.g. influenza virus
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- Y—GENERAL 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
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against 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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- Immunology (AREA)
- Virology (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Microbiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
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- Wood Science & Technology (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Biotechnology (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- General Engineering & Computer Science (AREA)
- Analytical Chemistry (AREA)
- Physics & Mathematics (AREA)
- Biomedical Technology (AREA)
- Pulmonology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biophysics (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Tropical Medicine & Parasitology (AREA)
- Cell Biology (AREA)
- Food Science & Technology (AREA)
Claims (12)
1. Postupak priprave antigena cjepiva u kulturi Vero stanične linije, koji sadrži korak testiranja na patogen izabran iz skupine koja sadrži parvovirus, JC poliomavirus i cirkovirus.
2. Postupak prema patentnom zahtjevu 1, naznačen time da je patogen porcin cirkovirus.
3. Postupak prema bilo kojem od patentnih zahtjeva 1 ili 2, naznačen time da se testira cjepivo i/ili virus sijač i/ili supstrat ćelije i/ili medij kulture.
4. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time da se izvodi na materijalu korištenom za stvaranje virusne kulture; na virusnoj kulturi; ili na materijalu ekstrahiranom i deriviranom iz virusne kulture.
5. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time da sadrži korak u kojem se virus sijač i/ili antigen cjepiva i/ili kultura testira na prisutnost patogena izabranog iz skupine koja sadrži: viruse parainfluence; Herpesviridae; Adenoviridae; Mikoplazme; avijske cirkoviruse; te avijske Reoviridae.
6. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time da se kultura testira imunokemijskom detekcijom i/ili detekcijom nukleinskih kiselina.
7. Postupak prema patentnom zahtjevu 6, naznačen time da se detekcija provodi pomoću ELI-SA i/ili PCR (uključujući RT-PCR).
8. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time da se testiranje provodi za vrijeme jedne od idućih etapa: virusna zaraza, etapa rasta, pobiranje virusa, procesiranje virusa, razdjeljivanje, ekstrakcija površinskih bjelančevina, stvaranje cjepiva, pakiranje cjepiva.
9. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time da se testiranje provodi kao dio normalne kontrole kvalitete.
10. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time da je antigen cjepiva iz virusa influence.
11. Postupak prema patentnom zahtjevu 10, naznačen time da je antigen cjepiva oslabljeni virus influence, virus influence osjetljiv na temperaturu ili virus influence prilagođen na hladnoću.
12. Postupak prema patentnom zahtjevu 10 ili 11, naznačen time da nadalje sadrži korak miješanja antigena iz više od jedne sorte virusa influence.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP04255471 | 2004-09-09 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20130962T1 true HRP20130962T1 (hr) | 2013-12-06 |
Family
ID=35520177
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR20100673T HRP20100673T1 (hr) | 2004-09-09 | 2005-09-09 | Smanjivanje potencijalnih jatrogenskih rizika povezanih s cjepivima protiv gripe |
| HR20110007T HRP20110007T1 (hr) | 2004-09-09 | 2011-01-05 | Smanjivanje potencijalnih jatrogenskih rizika povezanih s cjepivima protiv gripe |
| HRP20120640TT HRP20120640T1 (hr) | 2004-09-09 | 2012-08-07 | Smanjenje potencijalnih jatrogenih rizika vezanih uz cjepiva protiv gripe |
| HRP20130962TT HRP20130962T1 (hr) | 2004-09-09 | 2013-10-10 | Smanjenje potencijalnih iatrogenih rizika povezanih sa antigenima cjepiva |
Family Applications Before (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR20100673T HRP20100673T1 (hr) | 2004-09-09 | 2005-09-09 | Smanjivanje potencijalnih jatrogenskih rizika povezanih s cjepivima protiv gripe |
| HR20110007T HRP20110007T1 (hr) | 2004-09-09 | 2011-01-05 | Smanjivanje potencijalnih jatrogenskih rizika povezanih s cjepivima protiv gripe |
| HRP20120640TT HRP20120640T1 (hr) | 2004-09-09 | 2012-08-07 | Smanjenje potencijalnih jatrogenih rizika vezanih uz cjepiva protiv gripe |
Country Status (15)
| Country | Link |
|---|---|
| US (6) | US8119337B2 (hr) |
| EP (5) | EP1789084B1 (hr) |
| JP (7) | JP2008512443A (hr) |
| AT (2) | ATE489965T1 (hr) |
| CA (2) | CA2890962A1 (hr) |
| CY (3) | CY1111180T1 (hr) |
| DE (3) | DE12193096T1 (hr) |
| DK (4) | DK2236155T3 (hr) |
| ES (4) | ES2432655T3 (hr) |
| HR (4) | HRP20100673T1 (hr) |
| PL (4) | PL2236155T3 (hr) |
| PT (4) | PT2179744E (hr) |
| RS (3) | RS51665B (hr) |
| SI (4) | SI1789084T1 (hr) |
| WO (1) | WO2006027698A1 (hr) |
Families Citing this family (66)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2008512443A (ja) | 2004-09-09 | 2008-04-24 | カイロン ベーリング ゲーエムベーハー アンド カンパニー | インフルエンザワクチンに関連する潜在的医原性リスクの減少 |
| ES2310062B1 (es) | 2005-07-15 | 2009-11-13 | Bionostra, S.L. | Particulas pseudovirales vacias quimericas derivadas del virus causante de la enfermedad de la bursitis infecciosa (ibdv), procedimiento de obtencion y aplicaciones. |
| EP1951296B2 (en) * | 2005-11-01 | 2014-07-23 | Novartis Vaccines and Diagnostics GmbH | Cell-derived viral vaccines with low levels of residual cell dna by beta-propiolactone treatment |
| AU2006310339B2 (en) | 2005-11-04 | 2013-01-10 | Novartis Ag | Influenza vaccines including combinations of particulate adjuvants and immunopotentiators |
| EA014028B1 (ru) | 2005-11-04 | 2010-08-30 | Новартис Вэксинс Энд Диагностикс Срл | Эмульсии, содержащие свободное поверхностно-активное вещество в водной фазе в качестве адъюванта сплит вакцин против гриппа |
| NZ594482A (en) | 2005-11-04 | 2012-11-30 | Novartis Vaccines & Diagnostic | Influenza vaccines with reduced amount of oil-in-water emulsion as adjuvant |
| AU2006310337B9 (en) | 2005-11-04 | 2013-11-28 | Novartis Ag | Adjuvanted influenza vaccines including cytokine-inducing agents |
| PL2368572T3 (pl) | 2005-11-04 | 2020-11-16 | Seqirus UK Limited | Szczepionki z adjuwantem z niewirionowymi antygenami otrzymane z wirusów grypy hodowanych w hodowli komórkowej |
| EP2478916B1 (en) | 2006-01-27 | 2020-04-01 | Seqirus UK Limited | Influenza vaccines containing hemagglutinin and matrix proteins |
| JP2009534303A (ja) | 2006-03-24 | 2009-09-24 | 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 ゲーエムベーハー アンド カンパニー カーゲー | 冷蔵しないインフルエンザワクチンの保存 |
| JP2009532352A (ja) | 2006-03-31 | 2009-09-10 | ダブリュエーアールエフ−ウィスコンシン アラムナイ リサーチ ファウンデーション | ワクチンのための高力価組み換えインフルエンザ・ウィルス |
| GB0614460D0 (en) | 2006-07-20 | 2006-08-30 | Novartis Ag | Vaccines |
| BRPI0716536A2 (pt) | 2006-09-11 | 2013-09-24 | Novartis Ag | produÇço de vacinas de vÍrus influenza, sem a utilizaÇço de ovos |
| WO2008059018A2 (en) * | 2006-11-15 | 2008-05-22 | Intervet International B.V. | Vaccine for vaccinating felines and canines against influenza virus |
| EP2121011B1 (en) | 2006-12-06 | 2014-05-21 | Novartis AG | Vaccines including antigen from four strains of influenza virus |
| US9474798B2 (en) | 2007-06-18 | 2016-10-25 | Wisconsin Alumni Research Foundation | Influenza M2 protein mutant viruses as live influenza attenuated vaccines |
| CN101784283A (zh) | 2007-06-27 | 2010-07-21 | 诺华有限公司 | 低添加流感疫苗 |
| GB0810305D0 (en) | 2008-06-05 | 2008-07-09 | Novartis Ag | Influenza vaccination |
| JP5518041B2 (ja) | 2008-03-18 | 2014-06-11 | ノバルティス アーゲー | インフルエンザウイルスワクチン抗原の調製における改良 |
| JP2012507272A (ja) | 2008-11-05 | 2012-03-29 | グラクソスミスクライン バイオロジカルズ ソシエテ アノニム | 新規な方法 |
| KR20110132373A (ko) | 2009-02-10 | 2011-12-07 | 노파르티스 아게 | 유행병-연관 주에 대한 인플루엔자 백신 요법 |
| EA023662B1 (ru) | 2009-02-10 | 2016-06-30 | Новартис Аг | Вакцины против гриппа со сниженным количеством сквалена |
| CA2752041A1 (en) | 2009-02-10 | 2010-08-19 | Novartis Ag | Influenza vaccines with increased amounts of h3 antigen |
| USH2283H1 (en) | 2009-04-27 | 2013-09-03 | Novartis Ag | Vaccines for protecting against influenza |
| AU2010293902A1 (en) | 2009-09-10 | 2012-03-22 | Novartis Ag | Combination vaccines against respiratory tract diseases |
| JP2013507990A (ja) | 2009-10-26 | 2013-03-07 | ダブリュエーアールエフ−ウィスコンシン アラムナイ リサーチ ファウンデーション | ベロ細胞において増強された複製を有する高力価の組換えインフルエンザウイルス |
| US10130697B2 (en) | 2010-03-23 | 2018-11-20 | Wisconsin Alumni Research Foundation (Warf) | Vaccines comprising mutant attenuated influenza viruses |
| CN102858961A (zh) * | 2010-05-03 | 2013-01-02 | 葛兰素史密丝克莱恩生物有限公司 | 新方法 |
| EP2571520B1 (en) | 2010-05-21 | 2018-04-04 | Seqirus UK Limited | Influenza virus reassortment method |
| AU2011262309B2 (en) | 2010-06-01 | 2015-08-13 | Seqirus UK Limited | Concentration of influenza vaccine antigens without lyophilization |
| CA2801151A1 (en) | 2010-06-01 | 2011-12-08 | Novartis Ag | Concentration of vaccine antigens with lyophilization |
| GB201011502D0 (en) | 2010-07-08 | 2010-08-25 | Glaxosmithkline Biolog Sa | Novel process |
| EP2605792B1 (en) | 2010-08-20 | 2014-12-10 | Novartis AG | Soluble needle arrays for delivery of influenza vaccines |
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