Recent Updates
Recently added Catalysts

split-virion pandemic influenza vaccine

Phase 2

Influenza | Vaccine | Infectious Disease |Sinovac Biotech, Ltd|Trials Updated: Aug 12, 2009

split-virion pandemic influenza vaccine development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jun 2007

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment -

FDA Designations

No designations recorded

split-virion pandemic influenza vaccine clinical trials

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
InfluenzaUnlock trial analytics
PHASE2COMPLETED
Safety and Immunogenicity of a Split-Virion Pandemic Influenza A (H5N1) Vaccine in Children
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

HI antibody and Neutralization antibody

Secondary Endpoints

Adverse reactions
Unlock Study Endpoints

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 -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about split-virion pandemic influenza vaccine

What is the split-virion pandemic influenza vaccine?

The split-virion pandemic influenza vaccine is an investigational vaccine developed by Sinovac Biotech, Ltd for protection against pandemic influenza. It is based on the H5N1 strain NIBRG-14 and is designed for use in healthy volunteers, including children and adolescents. It is a vaccine candidate that has completed Phase 2 clinical testing in China.

What is the split-virion pandemic influenza vaccine used for?

The split-virion pandemic influenza vaccine is being developed for the prevention of influenza caused by pandemic H5N1 strains. Its clinical program has studied its use in healthy children and adolescents. It is intended to induce immune protection against pandemic influenza A (H5N1) virus.

Who makes the split-virion pandemic influenza vaccine?

The split-virion pandemic influenza vaccine is developed by Sinovac Biotech, Ltd, which trades under the ticker SVA. Sinovac is a China-based vaccine developer. The company conducted the Phase 2 clinical trials of this H5N1 pandemic influenza vaccine candidate in China.

What phase is the split-virion pandemic influenza vaccine in?

The split-virion pandemic influenza vaccine is in Phase 2 development. Both of its clinical trials, NCT00900991 and NCT00900588, are completed, and no trials are currently active. It is an investigational vaccine and has not been approved by the FDA.

What clinical trials is the split-virion pandemic influenza vaccine in?

Two completed Phase 2 trials have evaluated the split-virion pandemic influenza vaccine: NCT00900991, which studied safety and immunogenicity in children aged 3 years and older, and NCT00900588, which studied safety and immunogenicity in adolescents aged 12 years and older. Both were randomized, double-blind, active-controlled trials conducted in China.

Is the split-virion pandemic influenza vaccine the same as the H5N1 strain NIBRG-14 vaccine?

Yes. The split-virion pandemic influenza vaccine is also known as the split-virion pandemic influenza vaccine (H5N1 strain NIBRG-14). The NIBRG-14 designation refers to the specific H5N1 vaccine strain used in this Sinovac Biotech candidate, so both names refer to the same investigational vaccine.