drugset / Trial / NCT00240968
H5 Booster After a Two Dose Schedule
Non-randomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to determine whether a third dose of vaccines containing A/Vietnam/1203/04 provides more immunity than two doses. Subjects who participate in this study will have participated in DMID protocol 04-063 involving the A/Vietnam/1203/04. In this study, each subject will be asked to receive a third dose of the H5 vaccine at the same level administered in protocol 04-063. Subjects will be asked to record oral temperature and any experienced side effects for 7 days following the vaccine. Study procedures will include up to 3 blood sample collections. Participants will be involved in study related procedures for up to 6 months.
Timeline
- Start
- 2005-10
- Primary completion
- 2006-07
- Completion
- 2006-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | 45 ug | Intramuscular |
| Subject | Inactivated Influenza A/H5N1 Vaccine | Vaccine | 90 ug | Intramuscular |