Immunogenicity and safety of an intramuscular split-virion quadrivalent inactivated influenza vaccine in individuals aged ≥ 6 months in India

A quadrivalent split-virion inactivated influenza vaccine (IIV4; Fluzone (R) Quadrivalent, Sanofi Pasteur) has been available in the US since 2013 for individuals aged >= 6 months. Here, we describe the results of an open-label, multicenter trial (WHO Universal Trial Number U1111-1143-8370) evaluating the immunogenicity and safety of IIV4 in Indian children aged 6-35 months and 3-8 years, adolescents aged 9-17 years, and adults aged >= 18 years (n = 100 per group). Post-vaccination hemagglutination inhibition titers for all strains in all age groups were >= 8 fold higher than at baseline (range, 8-51). At least 70% of participants in all age groups seroconverted or had a significant increase in titer for each strain. The most common solicited reactions were injection-site pain and tenderness, plus fever in participants 6-23 months and myalgia in older children and adolescents. All injection-site reactions and most systemic reactions were grade 1 or 2 and resolved within 3 days. Only three vaccine-related unsolicited adverse events were reported, all of which were grade 1 or 2 and transient. No immediate adverse events, adverse events leading to study discontinuation, adverse events of special interest, or serious adverse events were reported. This study showed that IIV4 was well tolerated and highly immunogenic in all age groups. This adds important data on the safety, tolerability, and immunogenicity of influenza vaccines in India.