Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: A randomized trial

Abstract

Context: In the ongoing influenza pandemic, a safe and effective vaccine against 2009 influenza A(H1N1) is needed for infants and children. Objective: To assess the immunogenicity and safety of a 2009 influenza A(H1N1) vaccine in children. Design, Setting, and Participants: Randomized, observer-blind, age-stratified, parallel group study assessing 2 doses of an inactivated, split-virus 2009 influenza A(H1N1) vaccine in 370 healthy infants and children aged 6 months to less than 9 years living in Australia. Intervention: Intramuscular injection of 15 μg or 30 μg of hemagglutinin antigen dose of monovalent, unadjuvanted 2009 influenza A(H1N1) vaccine in a 2-dose regimen, administered 21 days a..