Immunogenicity results
The overall serogroup-specific seroresponse rates for serogroups ACWY 28 days following vaccination with NmCV-5 ranged from 70.5% (95% CI 67.8–73.2) for serogroup A to 98.5% (95% CI 97.6–99.2) for serogroup W (As the lowest seroresponse rate following MenACWY-D was to serogroup A, this was used as the comparator, for the purposes of the non-inferiority analysis, for serogroup X in NmCV-5. The difference in seroresponse rates for the shared serogroups ranged from 1.2% (96% CI −0.3–3.1) for serogroup W to 20.5% (96% CI 15.4–25.6) for serogroup A. The difference in the seroresponse rate comparing serogroup X in NmCV-5 to serogroup A in MenACWY-D was 47.2% (96% CI 42.8–51.6). The lower limit of the 96% CI was above the −10% non-inferiority margin for all serogroups for the overall population (The overall serogroup-specific rSBA GMT 28 days following vaccination with NmCV-5 ranged from 5587.2 (95% CI 5123.7–6092.5) for serogroup C to 31290.4 (95% CI 29222.2–33505.1) for serogroup X (As the lowest rSBA GMT following MenACWY-D was to serogroup C this was used as the comparator, for the purposes of the non-inferiority analysis, for serogroup X in NmCV-5. The adjusted rSBA GMT ratio for the shared serogroups ranged from 1.7 (98.98% CI 1.5–1.9) for serogroup A to 2.8 (98.98% CI 2.3–3.5) for serogroup C. The adjusted GMT ratio comparing serogroup X in NmCV-5 to serogroup C in MenACWY-D was 9.5 (98.98% CI 7.1–12.8). The lower limit of the 98.98% CI was above the 0.5 non-inferiority margin for all serogroups in the overall population (The percentage of participants with baseline and post-vaccination serogroup-specific rSBA titres of ≥ 8 and ≥ 128 are provided in 