drugset / Trial / NCT04669691
A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study is a pediatric dose-ranging study to evaluate the safety and immunogenicity of vaccination with different MF59-adjuvanted H5N1 vaccine formulations.
Timeline
- Start
- 2020-12-19
- Primary completion
- 2022-04-15
- Completion
- 2022-04-15
Publications
- Background 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.
- Background 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 |
|---|---|---|---|---|
| Subject | H5N1 antigen combined with MF59 adjuvant | Vaccine | — | Intramuscular |