CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 450 enrolled
Drug / intervention
Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine +2 morebiological
Likely dose
Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine 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/NCT00444951
NCT00444951Phase 3Completed
CompareCT.gov

Evaluation of the Response to a Single Dose of Menactra® in Adolescents Aged 16 to 19 Years Who Previously Received One Dose of Quadrivalent (A, C, Y, W 135) and at Least One Dose of Bivalent (A, C) Meningococcal Polysaccharide Vaccine in Saudi Arabia.

Sanofi Pasteur, a Sanofi Company·interventional·Posted Mar 8, 2007·Updated Jul 14, 2015

In Brief

A Phase 3 clinical trial evaluating Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine and Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine for Neisseria Meningitidis and Meningococcal Infections. Completed, enrolled 450 participants across 7 sites.

Detailed Summary

This study will be conducted among adolescents in Saudi Arabia who previously received one dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine. This study will evaluate the booster administration of Menactra® (Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine) compared with Mencevax® (Meningococcal A, C, Y, and W 135 Polysaccharide vaccine)in terms of their serum bactericidal antibody responses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeisseria Meningitidis, Meningococcal Infections
CountriesSaudi Arabia
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 8, 2007
Enrollment StartFeb 1, 2007
Primary CompletionFeb 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 19.3 years ago

Interventions

Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccinebiological

0.5 mL, Intramuscular

Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccinebiological

0.5 mL, Subcutaneous

Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccinebiological

0.5 mL, Intramuscular