Background: The incidence of meningococcal disease is highest in infants, yet there is currently no licensed vaccine in the
Objectives: To assess the immunogenicity and safety of a four dose series of an investigational HibMenCY vaccine.
Methods: In two Phase 3 studies, 8571
Results: Vaccination with HibMenCY was non-inferior to licensed Hib for anti-PRP ≥1.0 mg/mL (post-dose-3, 96.3% versus 91.2% respectively; post-dose-4, 99.2% in both groups). In the group receiving HibMenCY, the percentage of subjects with hSBA-MenC ≥1:8 was 98.8% post-dose-3 and 98.5% post-dose-4. Furthermore, the percentage of subjects receiving HibMenCY with hSBA-MenY ≥1:8 was 95.8% post-dose-3 and 98.8% post-dose-4. HibMenCY had a similar safety profile to ActHIB® with respect to adverse events (AEs) and serious AEs reported after doses 1, 2 and 3, and to PedvaxHIB® with respect to AEs reported up to 6 months post-dose-4. Serious AEs, emergency room visits, rash and new onset chronic disease were reported at a similar rate in both groups.
Conclusions: HibMenCY is as immunogenic as a licensed Hib vaccine and has an acceptable safety profile, potentially adding protection for infants against N. meningitidis serogroups C and Y without the need for additional injections.