drugset / Trial / NCT00912496
Booster Trial to 07-0019 With A/Anhui/05 With and Without MF59
RandomizedParallel-groupTriple-blindPrevention
Summary
This research will study safety and the body's immune (defense system) responses, including anti-H5 flu antibodies (the body's protective proteins found in the blood), to an inactivated influenza "H5" bird flu, virus vaccine. Participants will be assigned by chance to receive the vaccine injections with and without an adjuvant, (substance that can improve vaccine effectiveness so less vaccine may be used) MF59, or placebo (inactive substance). Five different vaccine dose strengths will be evaluated. About 735 healthy participants, ages 18-49 will be asked to take part in this study. Study procedures include physical exam, blood sampling, and use of a memory aid. Volunteers will participate for up to 13 months.
Timeline
- Start
- 2010-06
- Primary completion
- 2011-12
- Completion
- 2011-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | A/Anhui/05 | Vaccine | 3.75 ug | Other |
| Subject | A/Anhui/05 | Vaccine | 7.5 ug | Other |
| Subject | A/Anhui/05 | Vaccine | 7.5 ug/ml | Other |
| Subject | A/Anhui/05 | Vaccine | 15 ug | Other |
| Subject | A/Anhui/05 | Vaccine | 15 ug/ml | Other |
| Subject | A/Anhui/05 | Vaccine | 30 ug/ml | Other |
| Subject | A/Anhui/05 | Vaccine | 45 ug | Other |
| Subject | A/Anhui/05 | Vaccine | 60 ug/ml | Other |
| Subject | A/Anhui/05 | Vaccine | 90 ug | Other |
| Subject | MF59 | Other / unclassified | — | — |