At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity of a Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine (TetraMenD) In Toddlers 9 to 18 Months of Age
In Brief
A Phase 2 clinical trial evaluating Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®) and A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®) for Meningitis and Meningococcal Infection. Completed, enrolled 378 participants across 14 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
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)
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)