drugset / Trial / NCT01408290
Safety and Immunogenicity Study of Fluval AB-Like Flu Vaccines With 3.5, 6, 9 or 15 μg HA in Adult and Elderly People
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to determine the immunogenicity, tolerability and dose-effect relationship of one 0.5 mL intramuscular (IM) injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.
Timeline
- Start
- 2011-09
- Primary completion
- 2011-10
- Completion
- 2011-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FAB-3511 | Vaccine | 3.5 ug | Intramuscular |
| Subject | FAB-6011 | Vaccine | 6 ug | Intramuscular |
| Subject | FAB-9011 | Vaccine | 9 ug | Intramuscular |
| Subject | Fluval AB | Vaccine | 15 ug | Intramuscular |