Measles Clinical Trial
Official title:
An Immunogenicity, Safety, and Non-Interference Evaluation of Pediatric Vaccines Administered Concomitantly With Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) to Healthy Toddlers
This is a modified single-blind, randomized, parallel-group, comparative, multicenter study
to test Menactra vaccine in toddlers.
Primary Objectives:
- To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella
(MMRV) vaccine when administered alone or concomitantly with Menactra vaccine.
- To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV)
when administered alone or concomitantly with Menactra vaccine.
Observational Objectives:
Safety - To describe the safety profile throughout the course of the study from Day 0 up to
6 months after the last study vaccination[s]) in subjects in the study groups.
Immunogenicity:
- To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days
after the first and second Menactra vaccine administration in a subset of subjects in the
first study group.
No meningococcal vaccine is presently licensed for the population aged < 2 years in the US,
establishing the effectiveness of a quadrivalent polysaccharide conjugate vaccine against
invasive meningococcal disease in children aged < 2 years would address this important,
currently unmet public health need.
At enrollment, each 9-month old subject will be randomly assigned to a study group and
vaccinated. A second vaccination will be administered at 12 months of age. Subjects will
provide one blood sample during the trial.
Twelve-month old subjects will also be vaccinated with routine pediatric vaccines and
provide one blood sample 30 days after vaccinations in the control group
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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