Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children

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, Varsha K Jain, 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, Varsha K Jain

Abstract

Background: Mismatch between circulating influenza B viruses (Yamagata and Victoria lineages) and vaccine strains occurs frequently.

Methods: In 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.

Results: A 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).

Conclusion: QIV 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 registration: NCT01198756.

Keywords: children; immunogenicity; influenza vaccine.

Figures

Figure 1.
Figure 1.
Participant flow. Abbreviations: ATP, according-to-protocol; QIV, quadrivalent influenza vaccine; TIV-Vic, trivalent influenza vaccine Victoria lineage B strain; TIV-Yam, trivalent influenza vaccine Yamagata lineage B strain.
Figure 2.
Figure 2.
Solicited injection site adverse events (A) and general adverse events (B) in the 7 days after vaccination; Total Vaccinated Cohort.

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Source: PubMed

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