A phase III randomized study: Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine in healthy adults, adolescents, and children in India and healthy adolescents and children in South Africa.
Ashish Bavdekar, Danaya Chansinghakul, Ravi Mandyam Dhati et al.
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In 30 seconds
This Phase III randomized controlled trial assessed the immunogenicity and safety of a single dose of MenACYW-TT in healthy adults, adolescents, and children in India and in adolescents and children in South Africa. Among 1,328 participants, the primary objective was met: in children and adolescents aged 2–17 years, MenACYW-TT was non-inferior to MenACYW-DT for post-vaccination Day 30 seroprotection against all four serogroups. The lower limit of the 95% confidence interval for the difference in seroprotection rates was greater than -10%. Solicited reactions were comparable between vaccine groups, and no vaccine-related serious adverse events were reported.
Key findings
- In participants aged 2–17 years, MenACYW-TT was non-inferior to MenACYW-DT on Day 30; the lower 95% confidence limit for the seroprotection-rate difference was greater than -10%.
- Seroprotection was defined as hSBA titers ≥1:8 against all four meningococcal serogroups.
- Solicited injection-site and systemic reaction rates were comparable with MenACYW-TT and licensed comparator vaccines.
- No vaccine-related serious adverse events, study discontinuations, or deaths were reported.
Why it matters
The findings provide comparative evidence on immune responses and short-term safety for a single-dose quadrivalent meningococcal conjugate vaccine across age groups and two countries. Non-inferiority to MenACYW-DT in children and adolescents supports MenACYW-TT as an immunogenic option in the populations studied, while the reported adult responses add evidence for use across a broad age range.
What to keep in mind
The abstract reports immunogenicity at Day 30; it does not provide evidence on longer-term persistence of immune responses.