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

Abstract

A quadrivalent split-virion inactivated influenza vaccine (IIV4; Fluzone® 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.

Exploratory Study of the Phase IV Immunization Schedule of Quadrivalent Influenza Split-Virion Vaccine in Children Aged 3–8 Years

“…The symptoms and incidence rates of adverse reactions in all recipients that occurred in this study are consistent with the results of previous studies in which the common adverse reaction found was pressure or pain at the injection site [ 9 ]. Influenza is an acute respiratory infectious disease.…”

“…Adopting an immunization schedule based on the most recent scientific research for specific groups of individuals will help to ensure total protection. It has been shown that vaccinating children against influenza virus can increase their resistance [ 9 ]. However, the optimal vaccination regimen has not yet been precisely defined.…”

“…Thime et al found that no serious unsolicited adverse events or vaccine-related SAEs were reported in the Phase III clinical trial [ 15 ]. When the vaccine was administered to children, the most common reaction was pain and tenderness at the injection site, but this subsided within 3 days, and there was only one unsolicited adverse reaction associated with the vaccine, but these were Grade 2 or 4 transient [ 9 ]. In the present study, individuals in the NH group were vaccinated according to a two-dose schedule.…”

Unlocking the Power of Influenza Vaccines for Pediatric Population: A Narrative Review

“…These symptoms are temporary and usually subside within two to six days. Serious adverse events from influenza vaccines, such as severe allergic reactions, are extremely rare [12].…”

Protective Intranasal Immunization Against Influenza Virus in Infant Mice Is Dependent on IL-6

“…Although intramuscular administration of a polyvalent formulation of chemically inactivated or disrupted influenza virus is the most common type of vaccine for seasonal influenza both in adults and children (25), intranasal administration of a live attenuated influenza virus (LAIV) in the respiratory tract is also utilized as a method of vaccination (26). However, this formulation is restricted to children more than 2 years of age and adults (27,28) because of reports of increased risk of reactive airway disease (29,30) and increased concern over the presence of underlying asthma in young vaccine recipients (31,32).…”