CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 538 enrolled
Drug / intervention
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate +2 morebiological
Likely dose
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate 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.

Search/NCT01270503
NCT01270503Phase 4Completed
CompareCT.gov

Meningococcal (Groups A, C, Y, W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Post-Marketing Safety Study in Healthy Children (2-11 Years), Adolescents (12-17 Years) and Adults (18-55 Years) in the Philippines

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jan 5, 2011·Updated Nov 14, 2014

In Brief

A Phase 4 clinical trial evaluating Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate for Meningitis and Meningococcal Disease. Completed, enrolled 538 participants across 127 sites.

Detailed Summary

This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines. Primary Objective: To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningitis, Meningococcal Disease
CountriesPhilippines
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 5, 2011
Enrollment StartDec 1, 2010
Primary CompletionDec 1, 2013
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.5 years ago

Interventions

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugatebiological

0.5 mL, Intramuscular

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugatebiological

0.5 mL, Intramuscular

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugatebiological

0.5 mL, Intramuscular