H5 Adult - Chiron Study of Bird Flu Vaccine
Summary
This study is will gather critical information on the safety, tolerability, and the immunogenicity (capability of causing an immune response) of A/H5N1 (Bird flu) virus vaccine in healthy adults. Up to 400 healthy adults, aged 18 to 64, will participate. Each subject will participate for about 7 months and will be randomly placed in one of several different study groups receiving a different dose of vaccine or placebo. All subjects will receive two injections of their assigned study product, about 28 days apart, in the muscle. Subjects will keep a journal of their temperature and any adverse effects between study visits. A small amount of blood will also be drawn before the first injection, 7 days after each injection, 1 month after the first injection, and 1 and 6 months after the second injection.
Timeline
- Start
- 2006-02
- Primary completion
- 2006-11
- Completion
- 2006-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aluminum hydroxide | Unknown | — | — |
| Subject | Inactivated Influenza A/H5N1 Vaccine | Vaccine | 7.5 ug | Intramuscular |
| Subject | Inactivated Influenza A/H5N1 Vaccine | Vaccine | 15 ug | Intramuscular |
| Subject | Inactivated Influenza A/H5N1 Vaccine | Vaccine | 30 ug | Intramuscular |
| Subject | Inactivated Influenza A/H5N1 Vaccine | Vaccine | 45 ug | Intramuscular |
| Subject | MF59 | Other / unclassified | — | — |