Last updated on March 2019

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

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Investigational Site Number 8400039

Louisville, KY United States
5.13miles
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Recruitment Status: Open


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