CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,378 enrolled
Drug / intervention
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate +3 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/NCT00483574
NCT00483574Phase 3Completed

Safety Study of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) When Administered With Other Pediatric Vaccines to Healthy Toddlers

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jun 7, 2007·Updated May 16, 2016

In Brief

A Phase 3 clinical trial evaluating Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate, Measles-mumps-rubella-varicella vaccine, and 2 other interventions for Meningococcal Meningitis and 4 related conditions. Completed, enrolled 1,378 participants across 79 sites in 2 countries.

Detailed Summary

This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US. Safety Objective: To describe the safety profile of two doses of Menactra® Vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChile, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 7, 2007
Enrollment StartMay 1, 2007
Primary CompletionJan 1, 2009
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.1 years ago

Interventions

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugatebiological

0.5 mL, IM at age 9 and 12 months

Measles-mumps-rubella-varicella vaccinebiological

0.5 mL, intramuscular at 12 months of age

Routine paediatric vaccine - Pneumococcal conjugate (PCV)biological

0.5 mL, Intramuscular at age 12 months

Routine paediatric vaccine - Hepatitis Abiological

0.5 mL, Intramuscular at age 12 months