Immunogenicity and safety of an inactivated split-virion influenza vaccine in individuals 6 months of age and older in India.
Pedro M Folegatti, Cynthia Tabar, Celine Petit et al.
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In 30 seconds
This open-label, multicentre phase III clinical trial assessed immunogenicity and safety of a quadrivalent inactivated split-virion influenza vaccine in 401 participants aged 6 months and older at five sites in India. Participants received one or two doses according to age and vaccination history. Hemagglutination inhibition geometric mean titers rose from baseline for all four strains across age groups. Responses in children were comparable to or somewhat higher than adult responses, depending on strain. The vaccine was generally well tolerated, and no vaccine-related serious adverse events were reported.
Key findings
- HAI geometric mean titers increased from baseline for all four vaccine strains across all age groups.
- Pediatric responses were comparable to or somewhat higher than adult responses against all four strains.
- No vaccine-related serious adverse events occurred; solicited injection-site reactions were comparable across age groups.
Why it matters
The study adds Indian population data on immune responses and safety for a quadrivalent influenza vaccine across a broad age range, including infants and children. The findings support the vaccine’s ability to elicit antibody responses to all four strains in these groups, while the reported safety profile provides relevant evidence for evaluating influenza immunisation in this setting.
What to keep in mind
The study was open-label and had no comparator group, limiting comparative conclusions about safety or immunogenicity.