drugset
drugset / Trial / NCT04368429

Study of a Quadrivalent Meningococcal Conjugate Vaccine as a Single Dose Compared With a Single Dose of a Meningococcal Reference Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age

NCT04368429 ↗

Phase 3 Completed 360 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Primary Objective: To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) compared with those observed following the administration of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine). Secondary Objective: Immunogenicity: To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) after vaccination with MenACYW Conjugate vaccine or Menactra®. Safety: To describe the safety profile of MenACYW Conjugate vaccine and that of Menactra®.

Timeline

Start
2020-05-22
Primary completion
2020-11-07
Completion
2020-11-07

Drugs

EvaluationDrugModalityDoseRoute
Subject MenACYW conjugate vaccine Vaccine — Intramuscular
Comparator Menactra Vaccine — Intramuscular

Indications

No indication recorded.