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pandemic influenza vaccine

Phase 2

Pandemic Influenza | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Nov 9, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment402
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00535665Safety and Immunogenicity of an Inactivated Pandemic Influenza VaccinePHASE2 COMPLETED 402Sep 1, 2007Nov 1, 2007Nov 9, 2007 -
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Study Endpoints
Primary Endpoints
HI antibody and Neutralization antibody
0,28,42,56
Secondary Endpoints
adverse reactions
0,28,42,56
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1: 10 ug, 14 daysEXPERIMENTAL -
2: 5 ug, 28 daysEXPERIMENTAL -
3: 10 ug, 28 daysEXPERIMENTAL -
4: 15 ug, 28daysEXPERIMENTAL -
Interventions
NameTypeDescription
pandemic influenza vaccine (H5N1 strain NIBRG-14)BIOLOGICALtwo-dose regimen with 14 days apart: 5 microgram per dose
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy adults aged 18-60 years old * Be able to show legal identity card for the sake of recruitment * Be able to understand and sign the informed consent. Exclusion Criteria: * Woman: Who breast-feeding or planning to become pregnant during the 56 days of study participati...

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