At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Subjects Aged 9 to 23 Months in India and in the Russian Federation
In Brief
A Phase 3 clinical trial evaluating Meningococcal Diphtheria Toxoid Vaccine for Meningitis and Meningococcal Infection. Completed, enrolled 300 participants across 8 sites in 2 countries.
Detailed Summary
The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers. Primary Objectives: * To assess the seroprotection rate (percentage of subjects with a serum bactericidal assay using human complement \[SBA-HC\] titer ≥ 1:8) 28 days after the second of 2 doses of Menactra® administered 3 to 6 months apart. Secondary Objectives: * To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135) 28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers. * To assess the safety profile of Menactra® after each and any vaccination.
Study Details
Timeline
Interventions
0.5 mL, Intramuscular