The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age. Primary Objective: To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to \<6 years of age.
This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
378
0.5 mL, Intramuscular (at age 9 and 12 months)
0.5 mL, Intramuscular (at age 9 and 15 months)
0.5 mL, Intramuscular (at age 12 and 15 months)
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Norwich, Connecticut, United States
Unnamed facility
Atlanta, Georgia, United States
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Time frame: Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
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0.5 mL, Intramuscular (at age 15 months)
0.5 mL, Intramuscular (at age 18 months)
0.5 mL, Subcutaneous (at 3 years to \<6 years of age)
Unnamed facility
Marietta, Georgia, United States
Unnamed facility
Bardstown, Kentucky, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Woburn, Massachusetts, United States
Unnamed facility
Akron, Ohio, United States
Unnamed facility
Columbus, Ohio, United States
Unnamed facility
Drexel Hill, Pennsylvania, United States
...and 4 more locations