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Placebo-controlled Double-blind Controlled Trial of Single Intranasal Inoculation of CAIV-T Liquid Formulation in Healthy Japanese Male Adults
The primary objective of the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults.
Details
| Lead sponsor | MedImmune LLC |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 45 |
| Start date | 2002-08 |
| Completion | 2002-09 |
Conditions
- Healthy Japanese Male Adults
Interventions
- CAIV-T
- Placebo
Primary outcomes
- The number of subjects within each treatment arm who experienced influenza-like symptoms — Within 6 days post vaccination
Influenza-like symptoms, ie, typical clinical symptoms of influenza infection, including fever (oral temperature \> or = 38 degrees C), cough, runny or stuffy nose, sore throat, headache, chills, muscular pain, vomiting, decline in activity, decline in appetite.