drugset / Trial / NCT00966238
Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults >= 65 Years of Age
NaSingle-groupOpen-labelPrevention
Summary
A multi-center, open-label, escalating dose-ranging study to assess the safety, reactogenicity, and immunogenicity of four different VAX125 vaccine doses; 0.5 µg, 1.0 µg, 2.0 µg, or 3.0 µg, delivered i.m. as a single dose vaccination on Day 0. Hypothesis: VAX125 is safe and immunogenic at one or more of the doses tested.
Timeline
- Start
- 2009-09
- Primary completion
- 2010-04
- Completion
- 2011-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VAX125 | Vaccine | 0.5 ug | Intramuscular |
| Subject | VAX125 | Vaccine | 1 ug | Intramuscular |
| Subject | VAX125 | Vaccine | 2 ug | Intramuscular |
| Subject | VAX125 | Vaccine | 3 ug | Intramuscular |
| Subject | VAX125 | Vaccine | 5 ug | Intramuscular |
| Subject | VAX125 | Vaccine | 8 ug | Intramuscular |