CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 216 enrolled
Drug / intervention
Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide +3 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/NCT00874549
NCT00874549Phase 2Completed
CompareCT.gov

A Safety and Immunogenicity Evaluation of a Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) and a Meningococcal Polysaccharide Vaccine Groups A, C, Y, and W-135 Combined (Menomune® - A/C/Y/W-135) in Subjects 56 Years of Age or Older

Sanofi Pasteur, a Sanofi Company·interventional·Posted Apr 2, 2009·Updated Sep 20, 2013

In Brief

A Phase 2 clinical trial evaluating Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide and Menactra®: Polysaccharide Diphtheria Toxoid Conjugate for Meningococcal Infections and Meningococcal Meningitis. Completed, enrolled 216 participants across 6 sites.

Detailed Summary

Safety: To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination with either Menactra® vaccine or Menomune® vaccine. Immunogenicity: To evaluate the immune response to serogroups A, C, Y, and W-135 in each of the four study groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Infections, Meningococcal Meningitis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2, 2009
Enrollment StartOct 1, 2007
Primary CompletionJan 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.3 years ago

Interventions

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

0.5 mL, Subcutaneous

Menactra®: Polysaccharide Diphtheria Toxoid Conjugatebiological

0.5 mL, Intramuscular

Menactra®: Polysaccharide Diphtheria Toxoid Conjugatebiological

0.5 mL. Intramuscular

Menactra®: Polysaccharide Diphtheria Toxoid Conjugatebiological

0.5 mL, Intramuscular