drugset / Trial / NCT00952419
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after each injection. * To describe the safety of the candidate vaccines after each injection.
Timeline
- Start
- 2009-08
- Primary completion
- 2010-03
- Completion
- 2010-06
Publications
- Results Plennevaux E, Blatter M, Cornish MJ, Go K, Kirby D, Wali M, Reeves-Hoche MK, Denis M. Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine. 2011 Feb 11;29(8):1569-75. doi: 10.1016/j.vaccine.2010.12.116. Epub 2011 Jan 8.
- Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010 Jan 2;375(9708):41-8. doi: 10.1016/S0140-6736(09)62026-2. Epub 2009 Dec 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Monovalent Subvirion A/H1N1 Influenza vaccine | Vaccine | 0.25 ml | Intramuscular |
| Subject | Monovalent Subvirion A/H1N1 Influenza vaccine | Vaccine | 0.5 ml | Intramuscular |