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A Double-blind, Randomized, Stratified and Controlled Clinical Trial With Split-virion and Whole-virion, Adjuvanted and Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Adults, Elders, Adolescents and Children
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.
Details
| Lead sponsor | Sinovac Biotech Co., Ltd |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 1614 |
| Start date | 2009-07 |
| Completion | 2009-10 |
Conditions
- Influenza
Interventions
- split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose
- split-virion, adjuvanted H1N1 vaccine of 15 μg per dose
- split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose
- split-virion, non-adjuvanted H1N1 vaccine of 30 μg per dose
- whole-virion, adjuvanted H1N1 vaccine of 5 μg per dose
- whole-virion, adjuvanted H1N1 vaccine of 10 μg per dose
- placebo control
Primary outcomes
- Evaluate immunogenicity and safety of influenza A （H1N1）vaccines in elders, adults, adolescent and children . — July 2009- Sept. 2009
Countries
China