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Randomized, Modified, Double-blind, Placebo-controlled, Phase II, Dose-ranging Study of the Safety and Immunogenicity of Single Dose ChimeriVax-WN02 Vaccine in Healthy Adults. (WinVax004)
The purpose of this study is to determine if ChimeriVax West Nile vaccine is safe and effective in preventing West Nile disease in adults over 50 years of age.
Details
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 479 |
| Start date | 2008-10 |
| Completion | 2009-12 |
Conditions
- West Nile Fever
Interventions
- ChimeriVax-WN02 vaccine
- ChimeriVax-WN02 vaccine
- ChimeriVax-WN02 vaccine
- Placebo
Primary outcomes
- Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine — Day 0 and Day 28 post-vaccination
Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test. - Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. — Day 0 and Day 28 post-vaccination
Antibodies to vaccine were measured by the Plaque Reduction Neutralization Test. Seroconversion was defined as a four-fold or greater rise in titer between pre- and post-injection samples; or a post-vaccination (Day 28) titers of ≥ 1:20 in participants with baseline titer ≤ 1:10. - Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. — Day 0 up to Day 14 post-vaccination
Countries
United States