drugset / Trial / NCT00537524
Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years
RandomizedParallel-groupSingle-blindPrevention
Summary
Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination
Timeline
- Start
- 2007-09
- Primary completion
- 2007-10
- Completion
- 2008-05
Publications
- Results Vesikari T, Karvonen A, Tilman S, Borkowski A, Montomoli E, Banzhoff A, Clemens R. Immunogenicity and safety of MF59-adjuvanted H5N1 influenza vaccine from infancy to adolescence. Pediatrics. 2010 Oct;126(4):e762-70. doi: 10.1542/peds.2009-2628. Epub 2010 Sep 6.
- Vesikari T, Forsten A, Borkowski A, Gaitatzis N, Banzhoff A, Clemens R. Homologous and heterologous antibody responses to a one-year booster dose of an MF59((R)) adjuvanted A/H5N1 pre-pandemic influenza vaccine in pediatric subjects. Hum Vaccin Immunother. 2012 Jul;8(7):921-8. doi: 10.4161/hv.20248. Epub 2012 Jul 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | H5N1 Influenza Vaccine | Vaccine | 7.5 ug | Intramuscular |
| Comparator | H5N1 Influenza Vaccine | Vaccine | 0.25 ml | Intramuscular |
| Comparator | H5N1 Influenza Vaccine | Vaccine | 0.5 ml | Intramuscular |