CompletedPhase 4

A Clinical Trial With Influenza A/H1N1 Vaccines

China1,614 participantsStarted 2009-07

Plain-language summary

A single center, stratified, randomized and double-blind phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years) to evaluate the safety and immunogenicity of Sinovac's split-virion or whole-virion novel influenza A (H1N1) vaccines.

Who can participate

Age range3 Years

SexALL

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Inclusion criteria

✓. Healthy male or female aged 3 and older
✓. Be able to show legal identity card for the sake of recruitment
✓. Volunteers or their guardians are able to understand and sign the informed consent

Exclusion criteria

✕. Cases, cured cases and close contact of influenza A (H1N1) virus
✕. Women of pregnancy, lactation or about to be pregnant in 60 days
✕. Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
✕. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
✕. Autoimmune disease or immunodeficiency
✕. Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
✕. Diabetes mellitus (type I or II), with the exception of gestational diabetes
✕. History of thyroidectomy or thyroid disease that required medication within the past 12 months

What they're measuring

Evaluate immunogenicity and safety of influenza A （H1N1）vaccines in elders, adults, adolescent and children .

Timeframe: July 2009- Sept. 2009

Trial details

NCT IDNCT00956111

SponsorSinovac Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-09

View on ClinicalTrials.gov More Influenza trials