NCT01239043

Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 56 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants who were randomized and received either Menactra® or Menomune® vaccine in trial MTA29 will receive 1 dose of either Menactra® or Menomune®, respectively on Day 0 and will be followed-up for 28 days post-vaccination.

Conditions

• Meningitis
• Meningococcal Meningitis
• Meningococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide	0.5 mL, Subcutaneous
BIOLOGICAL	Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate	0.5 mL, Intramuscular

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-04-01
• Completion: 2012-02-01
• First posted: 2010-11-11
• Last updated: 2012-06-25
• Results posted: 2012-06-19

Locations

6 sites across 1 country: United States