At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 300 enrolled
Drug / intervention
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)biological
Likely dose
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®) 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects 2-55 Years of Age in India
In Brief
A Phase 3 clinical trial evaluating Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®) for Meningococcal Infection and Meningitis. Completed, enrolled 300 participants across 3 sites.
Detailed Summary
The purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration. Primary Objectives: * To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination. * To describe the safety profile of participants after one dose of Menactra®.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Infection, Meningitis
CountriesIndia
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartJun 2010
Primary CompletionFeb 2011
Study CompletionJun 2011
TodayJul 2026
First PostedMar 15, 2010
Enrollment StartJun 1, 2010
Primary CompletionFeb 1, 2011
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.3 years ago
Interventions
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)biological
0.5 mL, Intramuscular