Last updated on July 2020

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers


Brief description of study

The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age.

The secondary objective is to demonstrate the non-inferiority of the percentage of subjects with antibody titers to meningococcal serogroups A, C, Y, and W 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age.

The study also includes as an observational objective to describe the safety profile of MenACYW conjugate vaccine and MENVEO when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers.

Detailed Study Description

Study duration per participant is approximately 1 year in Group 1 and Group 2, and 10 months in Group 3 and Group 4. This duration includes a safety follow-up contact at 6 months after the last vaccination.

Clinical Study Identifier: NCT03691610

Find a site near you

Start Over

Investigational Site Number 8400021

Loxahatchee Groves, FL United States
  Connect »

Investigational Site Number 8400061

West Palm Beach, FL United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.