drugset / Trial / NCT00710866
Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to compare the antibody response and reaction rates in children age 6-23 months when they are given either the currently recommended schedule of two 0.25ml doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month apart.
Timeline
- Start
- 2008-08
- Primary completion
- 2009-03
- Completion
- 2009-03
Outcome
Mixed primary results
paper meeting the 10% test of superiority for the H3N2 (75.4% vs 47.6%; Δ = 27.8% [95% confidence interval (CI): 11.2-44.5]; P = .02) PMID 21768314 ↗
paper but not H1N1 (71.9% vs 54.0%; Δ = 18.0% [95% CI: 1.0-34.9]; P = .2). PMID 21768314 ↗
paper In toddlers, postimmunization seroprotection rates exceeded 85% for all 3 vaccine components without significant difference by dose. PMID 21768314 ↗
Publications
- Skowronski DM, Hottes TS, De Serres G, Ward BJ, Janjua NZ, Sabaiduc S, Chan T, Petric M. Influenza Beta/Victoria antigen induces strong recall of Beta/Yamagata but lower Beta/Victoria response in children primed with two doses of Beta/Yamagata. Pediatr Infect Dis J. 2011 Oct;30(10):833-9. doi: 10.1097/INF.0b013e31822db4dc.
- Skowronski DM, Hottes TS, Chong M, De Serres G, Scheifele DW, Ward BJ, Halperin SA, Janjua NZ, Chan T, Sabaiduc S, Petric M. Randomized controlled trial of dose response to influenza vaccine in children aged 6 to 23 months. Pediatrics. 2011 Aug;128(2):e276-89. doi: 10.1542/peds.2010-2777. Epub 2011 Jul 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion) | Vaccine | 0.25 ml | — |
| Subject | Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion) | Vaccine | 0.5 ml | — |