drugset / Trial / NCT01594320
A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 1
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts of the study.
Timeline
- Start
- 2012-04
- Primary completion
- 2012-07
- Completion
- 2013-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Monovalent Avian Influenza VLP (H5N1) | Vaccine | — | Intramuscular |