Last reviewed · How we verify
An Open Label Phase 1/2 Study to Assess Immunogenicity and Safety of Different Dose Levels of H1N1 Pandemic Influenza Vaccine in Healthy Adults Aged 18 Years and Older
The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.
Details
| Lead sponsor | Alachua Government Services, Inc. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 408 |
| Start date | 2009-08 |
| Completion | 2010-04 |
Conditions
- Influenza
- Pandemic Influenza
Interventions
- H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Primary outcomes
- Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination — 42 days
Countries
Austria, Germany