Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years

•Immunogenicity and safety of one dose of investigational MenACWY-CRM was assessed in Indian subjects.•Post-vaccination hSBA ≥8 was 72%, 95%, 94%, and 90% for serogroups A, C, W, and Y, respectively.•The vaccine was well tolerated with no safety concerns.•MenACWY-CRM induced a robust immune response in Indian subjects aged 2–75 years.

SummaryBackgroundThis phase 3, multi-center, open-label study evaluated the immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM, Menveo®; Novartis Vaccines and Diagnostics S.r.l., Siena, Italy) in healthy Indian subjects aged 2–75 years, to provide data for licensure in India.MethodsA total of 180 subjects were enrolled (60 subjects 2–10 years, 60 subjects 11–18 years, and 60 subjects 19–75 years) and received one dose of MenACWY-CRM. Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination. Adverse events were collected throughout the 29-day study period.ResultsPercentages of subjects with post-vaccination hSBA ≥8 were 72%, 95%, 94%, and 90% for serogroups A, C, W, and Y, respectively. Geometric mean titers rose 7-fold to 42-fold against the four serogroups. Similar immune responses were observed for the age subgroups 2–10 years, 11–18 years, and 19–75 years. Seroresponse rates at 1 month following vaccination were 72%, 88%, 55%, and 71% for serogroups A, C, W, and Y, respectively. The vaccine was well tolerated with no safety concerns.ConclusionA single dose of MenACWY-CRM induced a robust immune response against all four meningococcal serogroups and was well tolerated in an Indian population 2–75 years of age.