drugset / Trial / NCT00242424
Safety and Immunogenicity of Inactivated Influenza Virus Vaccine Among Healthy Children 6-12 Weeks of Age
Phase 2/3
Completed
1375 enrolled
Seattle Children's Hospital
Sanofi Pasteur, a Sanofi Company · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Study of the safety and immunogenicity (antibody producing capability) comparing inactivated influenza vaccine to placebo given to infants at 2 and 3 months of age. Infants will receive inactivated influenza vaccine at the same time as other vaccines on the routine immunization schedule. Infants will be randomized at enrollment to receive inactivated influenza vaccine or placebo at a 2:1 ratio. This study is double-blind, randomized, and placebo-controlled.
Timeline
- Start
- 2005-09
- Primary completion
- 2006-09
- Completion
- 2007-09
Publications
- Results Englund JA, Walter EB, Black S, et al. Safety and Immunogenicity of Fluzone Trivalent Inactivated Influenza Vaccine (TIV) in Infants 6-12 Weeks of Age. Presented at Infectious Disease Society of America (IDSA), Toronto, Oct. 14, 2006
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Influenza Virus Vaccine | Vaccine | 0.25 ml | — |
Indications
No indication recorded.