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Placebo Controlled Study to Generate Data Characterising Clinical Events, Physiological Responses and Immune Responses
The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models. 240 healthy participants (18-45y) will be enrolled, 228 will be administered a dose of Fluad on Day 0, 12 will receive a placebo on Day 0.
Details
| Lead sponsor | University Hospital, Ghent |
|---|---|
| Phase | PHASE4 |
| Status | COMPLETED |
| Enrolment | 240 |
| Start date | Thu Oct 02 2014 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Aug 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Safety Markers of Adjuvanted Influenza Vaccine
Interventions
- Fluad
- Saline
Countries
Belgium