drugset / Trial / NCT03158038
Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This prospective annual release study is designed to evaluate the safety of 1 new influenza virus vaccine strain to be included in FluMist Quadrivalent for the 2017-2018 influenza season.
Timeline
- Start
- 2017-05-30
- Primary completion
- 2017-12-14
- Completion
- 2017-12-14
Outcome
Missed primary endpoint
registry analysis (superiority test); Monovalent Influenza Vaccine vs Placebo; Rate difference 0 (95% CI -6.7 to 1.9) NCT03158038 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Monovalent Influenza Vaccine | Vaccine | 1e+07 unknown | Intranasal |