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split-virion pandemic influenza vaccine

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Aug 12, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

split-virion pandemic influenza vaccine · 2 trials · 1 indication

Phase 2 2
NCT00900588Safety and Immunogenicity of a Split-Virion Pandemic Influenza A (H5N1) Vaccine in AdolescentsInfluenza
COMPLETED- Analytics
NCT00900991Safety and Immunogenicity of a Split-Virion Pandemic Influenza A (H5N1) Vaccine in ChildrenInfluenza
COMPLETED- Analytics
PHASE2COMPLETED
Safety and Immunogenicity of a Split-Virion Pandemic Influenza A (H5N1) Vaccine in Adolescents
Influenza
NCT00900588-
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PHASE2COMPLETED
Safety and Immunogenicity of a Split-Virion Pandemic Influenza A (H5N1) Vaccine in Children
Influenza
NCT00900991-
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Study Endpoints

Primary Endpoints

HI antibody and Neutralization antibody

Secondary Endpoints

Adverse reactions
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
10 ugEXPERIMENTAL10 microgram split-virion vaccine per dose
15 ugEXPERIMENTAL15 microgram split-virion vaccine per dose
30 ugEXPERIMENTAL30 microgram split-virion vaccine per dose
5 ugACTIVE_COMPARATOR5 microgram whole-virion vaccine per dose

Interventions

NameTypeDescription
split-virion pandemic influenza vaccine (H5N1 strain NIBRG-14)BIOLOGICAL -
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Eligibility Criteria

Age Range12 Years to 17 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adolescent aged 12-17 years old * Be able to show legal identity card for the sake of recruitment * Volunteers or their parents are able to understand and sign the informed consent * Do not participate in other clinical trial Exclusion Criteria: * Any history of alle...

Countries:China
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Competitive Landscape -Influenza 14 trials

CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK2PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sanofi SA Sponsored ADRSNY2 - Efluelda Tetra Pre-filled syringe
Pfizer Inc.PFE1 - COVID-19 Vaccine
Abbott LaboratoriesABT1N/AUndisclosed
Grace Therapeutics, Inc.GRCE1N/AUndisclosed
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