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pandemic influenza vaccine

Phase 2

Pandemic Influenza | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Apr 17, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment402

FDA Designations

No designations recorded

Clinical trial landscape

pandemic influenza vaccine · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT00535665Safety and Immunogenicity of an Inactivated Pandemic Influenza VaccinePandemic Influenza
COMPLETED402 Analytics
PHASE2COMPLETED
Safety and Immunogenicity of an Inactivated Pandemic Influenza Vaccine
Pandemic Influenza
NCT00535665402
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Study Endpoints

Primary Endpoints

HI antibody and Neutralization antibody
0,28,42,56
HI antibody Neutralization antibody
15 and 30 days after the booster dose

Secondary Endpoints

adverse reactions
0,28,42,56
local adverse reactions systemic adverse reactions temperature
3 days after booster dose
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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 -
No.1: 1.25 ugEXPERIMENTAL -
No.2: 2.5 ugEXPERIMENTAL -
No.3: 5.0 ugEXPERIMENTAL -
No. 4: 10 ugEXPERIMENTAL -

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 to 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...

Countries:China
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Frequently asked questions about pandemic influenza vaccine

What is pandemic influenza vaccine used for?

Pandemic influenza vaccine is used for the prevention of pandemic influenza, including infection with the H5N1 strain. It is designed to protect against pandemic influenza viruses and is being developed as an inactivated, adjuvanted whole-virion vaccine.

Who makes pandemic influenza vaccine?

Sinovac Biotech, Ltd (ticker: SVA) is developing the pandemic influenza vaccine. The company is conducting clinical trials to evaluate the safety and immunogenicity of the vaccine for pandemic influenza prevention.

What phase is pandemic influenza vaccine in?

The pandemic influenza vaccine is in Phase 2 clinical development. A Phase 2 trial has been completed, and a Phase 1 trial for a booster dose has also been completed. The vaccine remains investigational and is not yet approved.

What clinical trials is pandemic influenza vaccine in?

The pandemic influenza vaccine has been studied in two completed trials: NCT00535665, a Phase 2 study of safety and immunogenicity in 402 participants, and NCT00660257, a Phase 1 study of a booster dose in 57 participants in China.

Is pandemic influenza vaccine the same as an H5N1 vaccine?

Yes, the pandemic influenza vaccine is an inactivated, adjuvanted whole-virion vaccine targeting the H5N1 strain of pandemic influenza. It is being evaluated for its ability to prevent pandemic influenza caused by this virus.