Last updated on August 2019

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


Brief description of study

The purpose of this study is to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.

Primary objectives:

  • To demonstrate the non-inferiority of the immune response after a 4-dose series of MenACYW conjugate vaccine compared to a 4-dose series of MENVEO when given concomitantly with routine pediatric vaccines to infants and toddlers 6 weeks to 15 months of age.
  • To demonstrate the non-inferiority of the immune response after 3 doses of MenACYW conjugate vaccine compared to 3 doses of MENVEO when given concomitantly with routine pediatric vaccines to infants at 2, 4, and 6 months of age.

Secondary objective:

  • To demonstrate the non-inferiority of the immune responses of the routine pediatric vaccines administered concomitantly with MenACYW conjugate vaccine as compared with MENVEO to infants and toddlers 6 weeks to 18 months of age.
  • To assess the antibody responses against meningococcal serogroups A, C, Y, and W after the administration of the 4th dose of MenACYW conjugate vaccine as compared with MENVEO when both are given concomitantly with routine pediatric vaccines at 12 months of age.
  • To assess the persistence of bactericidal antibodies at 12 months of age (prior to the 4th dose) in participants who previously received 3 doses of MenACYW conjugate vaccine or MENVEO in infancy concomitantly with routine pediatric vaccines at 2, 4, and 6 months of age.

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

Healthy infants will be enrolled and randomized to receive either 4 doses of MenACYW conjugate vaccine or 4 doses of the licensed control vaccine, MENVEO. All participants will receive routine vaccines as per the Advisory Committee on Immunization Practices (ACIP) recommendations.

All participants will be assessed for immunogenicity at baseline (pre-vaccination), and after completing the infant schedule and the second year of life vaccination schedule.

Safety will be assessed throughout the study period, and includes solicited injection site and systemic reactions as well as unsolicited adverse events after each vaccine injection, and serious adverse events occurring throughout the trial.

Clinical Study Identifier: NCT03537508

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