drugset / Trial / NCT00873912
A Prospective Study to Evaluate the Safety of a New Monovalent Intranasal Influenza Vaccine
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This prospective annual release study was designed to assess the safety of a monovalent influenza virus vaccine using a new strain recommended for the 2009-2010 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults received a single dose of vaccine or placebo and were followed for 180 days.
Timeline
- Start
- 2009-05
- Primary completion
- 2009-05
- Completion
- 2009-12
Outcome
Met primary endpoint
registry rate difference -1.3 (95% CI -7.9 to 1.3); score statistic NCT00873912 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Monovalent influenza virus vaccine | Vaccine | 0.5 ml | Intranasal |
| Subject | Monovalent influenza virus vaccine | Vaccine | 1e+07 unknown | Intranasal |
Indications
No indication recorded.