Reverse cumulative distributions curves pre- (day 0) and post-vaccination (day 28)
Nm-CV-5, pain
ADVERSE EVENTS, INJECTION SITE REACTION
Nm-CV-5 – Serum Institute of India Pvt. Ltd pentavalent ACWYX meningococcal conjugate vaccine; MenACWY-D – Sanofi Pasteur quadrivalent meningococcal conjugate vaccine (MenactraDemographic and anthropometric characteristics, safety populationNm-CV-5 – Serum Institute of India Pvt. Ltd pentavalent ACWYX meningococcal conjugate vaccine; MenACWY-D – Sanofi Pasteur quadrivalent meningococcal conjugate vaccine (MenactraNon-inferiority analysis based on (A) rSBA antibody seroresponse rates and (B) geometric mean titres, per protocol populationrSBA – rabbit complement serum bactericidal activity; NmCV-5 – Serum Institute of India Pvt. Ltd pentavalent ACWYX meningococcal conjugate vaccine; MenACWY-D – Sanofi Pasteur quadrivalent meningococcal conjugate vaccine (Menactra- NmCV-5 seroresponse rate minus MenACWY-D seroresponse rate- difference between serogroup X seroresponse rate following NmCV-5 and lowest seroresponse rate to serogroups A, C, W and Y following MenACWY-D (i.e., serogroup A in all cases)- NmCV-5 GMT/MenACWY-D GMT- Ratio of serogroup X GMT following NmCV-5 and the lowest GMT to serogroups A, C, W and Y following MenACWY-D (i.e., serogroup C in all cases); Seroresponse was defined as a post-vaccination rSBA titre of ≥ 32 in participants with a pre-vaccination rSBA titre of < 8; or at least a 4-fold increase over baseline in the post-vaccination rSBA titre in participants who had a pre-vaccination rSBA titre of ≥ 8.; The 95% CIs around seroresponse rates for each treatment group were calculated by using the Clopper-Pearson method. The 2-sided 96% CIs for the difference (NmCV-5 - Menactra) in percentages between the 2 groups were constructed using the Miettinen and Nurminen method. Post-vaccination GMT and 95% CI were calculated by exponentiating the corresponding logParticipants reporting solicited and unsolicited adverse events, safety populationNm-CV-5 – Serum Institute of India Pvt. Ltd pentavalent ACWYX meningococcal conjugate vaccine; MenACWY-D – Sanofi Pasteur quadrivalent meningococcal conjugate vaccine (MenactraOverall injection site reactions and pain at the injection site were higher in the NmCV-5 than the MenACWY-D group (p = 0.001 in both cases [Fisher’s exact test])Collected for seven days after vaccination; the denominator for the percentages was 399 for 2 to10-year-olds in the NmCV-5 group, 199 for 18 to 29-year-olds in the MenACWY-D group, 1199 for the overall NmCV-5 group, 599 for the overall MenACWY-D group, and respective N for other combinations of age group and vaccine groupCollected for 28 days after vaccinationCollected for 168 days after vaccination.