Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-DT): A Multicenter, Open-label, Non-randomized, Phase III Clinical Trial.

ABSTRACT

Objective: To assess the safety and immunogenicity of a quadrivalent meningococcal (groups A,C,Y,W) polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-DT) in India. Design: Open-label, descriptive, non-randomized study. Setting: Three medical college hospitals, one each in New Delhi, Bengaluru and Mumbai, India. Participants: 300 healthy, vaccine-naïve participants (100 children aged 2-11 years, 100 adolescents aged 12-17 years, and 100 adults aged 18-55 years). Intervention One dose (0.5 mL) of MenACYW-DT administered intramuscularly. Main outcome measures: Serum bactericidal antibody titers against A, C, Y, and W were measured before and after MenACWY-DT vaccination. Safety data were also collected Results: Thirty days post-vaccination, geometric mean titers rose across all serogroups. Most participants had protective titers ≥8 (1/dil) across the four serogroups. The percentage (95% CI) achieving ≥8 (1/dil) in the Adolescent Group was typical – A 96.9% (91.2%; 99.4%); C 96.9% (91.2%; 99.4%); Y100% (96.3%; 100%); W100% (96.3%; 100%). In general, solicited reactions were mild and short-lived. Unsolicited events were uncommon and unrelated to vaccination. Conclusions: MenACYW-DT was well tolerated and elicited a robust and protective immune response 30 days post-vaccination against meningococcal serogroups A, C, Y, and W-135 in the Indian study participants aged 2-55 years.