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

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

Outcome

Met primary endpoint

registry analysis (non-inferiority test); Group 1: MenACYW Conjugate Vaccine vs Group 2: Menactra® Vaccine; Difference in percentage 20.27 (95% CI 11.38 to 28.75) NCT04368429 ↗

registry analysis (non-inferiority test); Group 1: MenACYW Conjugate Vaccine vs Group 2: Menactra® Vaccine; Difference in percentage 33.98 (95% CI 26.20 to 41.50) NCT04368429 ↗

registry analysis (non-inferiority test); Group 1: MenACYW Conjugate Vaccine vs Group 2: Menactra® Vaccine; Difference in percentage 34.22 (95% CI 26.66 to 41.64) NCT04368429 ↗

registry analysis (non-inferiority test); Group 1: MenACYW Conjugate Vaccine vs Group 2: Menactra® Vaccine; Difference in percentage 38.19 (95% CI 28.93 to 46.53) NCT04368429 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MenACYW conjugate vaccine	Vaccine	—	Intramuscular
Comparator	Menactra	Vaccine	—	Intramuscular

Indications

No indication recorded.