Measles Clinical Trial
Official title:
An Immunogenicity and Safety Evaluation of Two Doses of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Given to Healthy Subjects at 9 and 12 Months of Age
This is a Phase III, modified single-blind, randomized, parallel-group, multicenter,
comparative trial in the United States designed to evaluate the immunogenicity and safety of
two doses of Menactra vaccine administered alone, and concomitantly with other routine
pediatric vaccines typically administered between 12 and 15 months of age.
Primary Objective:
To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135.
Secondary Objectives:
Immunogenicity
- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when
Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines.
- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when
Menactra vaccine is administered alone or concomitantly with PCV vaccine.
Safety
- To describe the safety profile within 7 and 30 days of each vaccination, and serious
adverse events (SAEs) throughout the course of the study.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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