CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 238 enrolled
Drug / intervention
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate +1 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/NCT00539032
NCT00539032Phase 3Completed
CompareCT.gov

Evaluation of the Response to a Single Dose of Menactra® in Children Aged 5 to 8 Years Who Had Previously Received Two Doses of Quadrivalent (A, C, Y, W-135) Meningococcal Polysaccharide Vaccine Before Age 2 Years in Saudi Arabia

Sanofi Pasteur, a Sanofi Company·interventional·Posted Oct 3, 2007·Updated Apr 14, 2016

In Brief

A Phase 3 clinical trial evaluating Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate for Meningitis and Meningococcemia. Completed, enrolled 238 participants across 4 sites.

Detailed Summary

This study will be conducted among children in Saudi Arabia who previously received two doses of A, C, Y, W-135 polysaccharide vaccine before the age of 2 years, and in meningococcal vaccine-naïve children (Control Group). This study will evaluate the administration of Menactra® in terms of the serum bactericidal antibody it induces in the two study groups. Safety of Menactra® vaccine will be described.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningitis, Meningococcemia
CountriesSaudi Arabia
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 3, 2007
Enrollment StartSep 1, 2007
Primary CompletionAug 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.7 years ago

Interventions

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugatebiological

0.5 mL, Intramuscular

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugatebiological

0.5 mL, Intramuscular