• Joanne M Langley, Alfonso Carmona Martinez, Archana Chatterjee, Scott A Halperin, Shelly McNeil, Keith S Reisinger, Naresh Aggarwal, Li-Min Huang, Ching-Tien Peng, José Garcia-Sicilia, Ignacio Salamanca de la Cueva, Fernando Cabañas, Consuelo Treviño-Garza, Miguel Angel Rodríguez-Weber, Manuel de la O, Vijayalakshmi Chandrasekaran, Walthère Dewé, Aixue Liu, Bruce L Innis, and Varsha K Jain.
• Canadian Center for Vaccinology, Dalhousie University and the IWK Health Centre, Halifax, Nova Scotia, Canada.
• J. Infect. Dis. 2013 Aug 15; 208 (4): 544-53.

BackgroundMismatch between circulating influenza B viruses (Yamagata and Victoria lineages) and vaccine strains occurs frequently.MethodsIn a randomized controlled trial, immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate (QIV) versus trivalent inactivated influenza vaccine (TIV)-Victoria(Vic) and TIV-Yamagata(Yam) in children 3-17 years of age was evaluated. In an open-label study arm, QIV only was assessed in children 6-35 months of age.ResultsA total of 3094 children (932 QIV, 929 TIV-Vic, 932 TIV-Yam, and 301 QIV only) were vaccinated. QIV was noninferior to the TIVs for shared strains (A/H3N2 and A/H1N1) based on hemagglutination-inhibition (HI) antibodies 28 days after last vaccination, and superior for the unique B strains Victoria and Yamagata (geometric mean titer ratios 2.61, 3.78; seroconversion rate differences 33.96%, 44.63%). Among children in the randomized trial, adverse event rates were similar except for injection site pain (dose 1: 65.4% QIV, 54.6% TIV-Vic, 55.7% TIV-Yam).ConclusionQIV elicited superior HI responses to the added B strains compared to TIV controls, potentially improving its effectiveness against influenza B. HI responses were similar between QIV and TIV controls for the shared strains. QIV had an acceptable safety profile relative to TIVs.Clinical Trials RegistrationNCT01198756.

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