Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects From 6 Months to 17 Years of Age

Summary

The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and adolescents. A booster dose will be administered 12 months after the first vaccination.

Timeline

Start

2009-08

Primary completion

2010-03

Completion

2011-08

Publications

• Results Knuf M, Leroux-Roels G, Rumke H, Rivera L, Pedotti P, Arora AK, Lattanzi M, Kieninger D, Cioppa GD. Immunogenicity and safety of cell-derived MF59(R)-adjuvanted A/H1N1 influenza vaccine for children. Hum Vaccin Immunother. 2015;11(2):358-76. doi: 10.4161/21645515.2014.987014.

Drugs

Indications