CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 139 enrolled
Drug / intervention
Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide +1 morebiological
Likely dose
Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide 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/NCT01239043
NCT01239043Phase 2Completed

Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® Vaccine Approximately Three Years Following Initial Vaccination in Adults Who Participated in Trial MTA29

Sanofi·interventional·Posted Nov 11, 2010·Updated Jun 25, 2012

In Brief

A Phase 2 clinical trial evaluating Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide and Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate for Meningitis and 2 related conditions. Completed, enrolled 139 participants across 6 sites.

Detailed Summary

The purpose of this trial is to describe antibody persistence and response to re-vaccination with either Menactra® or Menomune® vaccine approximately three years following initial vaccination in adults who participated in trial MTA29 (NCT00874549). Objectives: * To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination. * To evaluate persistence of serum bactericidal antibodies in subjects who received Menactra® or Menomune® vaccine approximately three years ago. * To evaluate the immune response to serogroups A, C, Y, and W-135 in subjects re-vaccinated with either Menactra® or Menomune® vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2010
Enrollment StartNov 1, 2010
Primary CompletionApr 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.6 years ago

Interventions

Menomune®: A, C, Y, W 135 Meningococcal Polysaccharidebiological

0.5 mL, Subcutaneous

Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugatebiological

0.5 mL, Intramuscular