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an inactivated whole virion H5N1 vaccine, adjuvanted

Phase 1

Influenza | Vaccine | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Nov 9, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

an inactivated whole virion H5N1 vaccine, adjuvanted · 1 trial · 1 indication

Phase 1 1
NCT00356798Randomized, Double Blinded, Placebo Control Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy SubjectsInfluenza
COMPLETED120 Analytics
PHASE1COMPLETED
Randomized, Double Blinded, Placebo Control Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy Subjects
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety of pandemic inactivated influenza vaccine by different does.

Secondary Endpoints

To evaluate the immunogenicity of pandemic inactivated influenza vaccine by different does.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelFACTORIAL
PurposePREVENTION

Interventions

NameTypeDescription
an inactivated whole virion H5N1 vaccine, adjuvantedBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males and females, age from 18 to 60 years old; * Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process; * Able and willing to complete the informed consent process. Exclusion Criteria: * Woman who is breast-feeding or...

Countries:China
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Frequently asked questions about an inactivated whole virion H5N1 vaccine, adjuvanted

What is the inactivated whole virion H5N1 vaccine, adjuvanted?

It is an investigational pandemic influenza vaccine developed by Sinovac Biotech, Ltd. It uses inactivated whole virion H5N1 virus with an adjuvant and is intended for the prevention of influenza. It is in Phase 1 clinical development and has been studied in healthy adult volunteers.

What is the inactivated whole virion H5N1 vaccine, adjuvanted used for?

It is being developed for the prevention of influenza caused by the H5N1 avian influenza virus. The vaccine is intended for use in healthy adults. Its only recorded clinical study enrolled healthy volunteers aged 18 years and older in China.

Who makes the inactivated whole virion H5N1 vaccine, adjuvanted?

Sinovac Biotech, Ltd. is the developer of the inactivated whole virion H5N1 vaccine, adjuvanted. The company trades under the ticker SVA. Sinovac is a vaccine-focused biopharmaceutical company, and this H5N1 pandemic influenza candidate is one of its infectious disease programs.

What phase is the inactivated whole virion H5N1 vaccine, adjuvanted in?

It is in Phase 1 clinical development. The single recorded trial, NCT00356798, was a Phase 1 study that has been completed. No later-phase trials are listed, so the vaccine remains investigational and is not an approved product.

What clinical trials is the inactivated whole virion H5N1 vaccine, adjuvanted in?

One trial is recorded: NCT00356798, titled a randomized, double blinded, placebo controlled clinical trial of pandemic influenza inactive vaccine in healthy subjects. It was a completed Phase 1 study with 120 enrolled participants, conducted in China, in adults aged 18 years and older.

How was the Phase 1 trial of the inactivated whole virion H5N1 vaccine, adjuvanted designed?

NCT00356798 was a randomized, double blinded, placebo controlled Phase 1 trial. It enrolled 120 healthy volunteers aged 18 years and older in China and has been completed. The study evaluated the pandemic influenza inactivated vaccine in this healthy adult population.