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drugset / Trial / NCT03890367

Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in European Toddlers

NCT03890367 ↗

Phase 3 Completed 707 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Primary Objective: To demonstrate: * the non-inferiority of the seroprotection rate (antibody titers greater than or equal to \[\>=\] 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA). If this non-inferiority was demonstrated, then * the non-inferiority of the antibody response (geometric mean titers \[GMT\]). If this non-inferiority was demonstrated, then * the superiority of the antibody response (GMT). If this superiority was demonstrated, then * the superiority of the seroprotection rate. Or to demonstrate: * the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or NeisVac-C® as measured by serum bactericidal assay using baby rabbit complement (rSBA). If this non-inferiority was demonstrated, then * the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then * the superiority of the antibody response (GMT). Secondary Objective: To demonstrate: * the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or Nimenrix® as measured by rSBA. If this non-inferiority was demonstrated, then * the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then * the superiority of the antibody response (GMT). Or to demonstrate: * the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or NeisVac-C® as measured by hSBA. If this non-inferiority was demonstrated, then * the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then * the superiority of the antibody response (GMT) .

Timeline

Start
2019-09-12
Primary completion
2020-10-14
Completion
2020-10-14

Outcome

Met primary endpoint

registry analysis (non-inferiority test); Group 1: MenACYW Conjugate Vaccine vs Group 2: Nimenrix® Vaccine; Difference in Percentage 10.43 (97.5% CI 5.68 to 16.2) NCT03890367 ↗

registry analysis (superiority test); Group 1: MenACYW Conjugate Vaccine vs Group 2: Nimenrix® Vaccine; GMT Ratio 16.3 (97.5% CI 12.7 to 21.0) NCT03890367 ↗

registry analysis (superiority test); Group 1: MenACYW Conjugate Vaccine vs Group 3: NeisVac-C® Vaccine; GMT Ratio 1.32 (97.5% CI 1.06 to 1.64) NCT03890367 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject MenACYW conjugate vaccine Vaccine — Intramuscular
Comparator NeisVac-C Vaccine — Intramuscular
Comparator Nimenrix Vaccine — Intramuscular

Indications

No indication recorded.