drugset / Trial / NCT00908687
A/H5N1/LT Dose Ranging Study
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with or without a patch (low or high dose).
Timeline
- Start
- 2009-05
- Primary completion
- 2010-01
- Completion
- 2011-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | A/H5N1 | Vaccine | 30 ug | Intramuscular |
| Subject | A/H5N1 | Vaccine | 45 ug | Intramuscular |
| Subject | LT Adjuvant Patch | Unknown | 50 ug | — |
| Subject | LT Adjuvant Patch | Unknown | 100 ug | — |