CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 173 enrolled
Drug / intervention
A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®) +1 morebiological
Likely dose
A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®) 0.05 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/NCT00772070
NCT00772070Phase 2Completed
CompareCT.gov

Antibody Responses to a Reduced Dose of Menomune® in Children Who Previously Received an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, TetraMenD

Sanofi Pasteur, a Sanofi Company·interventional·Posted Oct 15, 2008·Updated Feb 14, 2014

In Brief

A Phase 2 clinical trial evaluating A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®) for Meningitis and 2 related conditions. Completed, enrolled 173 participants across 8 sites.

Detailed Summary

This study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in children who were vaccinated with one dose of TetraMenD at least 18 months earlier. Primary Objective: To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine to those responses in participants who received the same reduced dose of Menomune® but had not previously received any meningococcal vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningitis, Meningococcemia, Neisseria Meningitidis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 15, 2008
Enrollment StartMar 1, 2003
Primary CompletionAug 1, 2003
Study CompletionMay 1, 2004
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.7 years ago

Interventions

A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)biological

0.05 mL, Subcutaneous

A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)biological

0.05 mL, Subcutaneous