NCT01442675

Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine

Safety and Immunogenicity of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 834 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 15 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to describe the safety and antibody response to revaccination with Menactra vaccine in persons who received their first dose at ≥11 years of age. Primary Objective: \- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured by serum bactericidal assay using human complement (SBA-HC), induced by Menactra vaccine in subjects who were first vaccinated with Menactra 4-6 years ago. Secondary Objective: \- To evaluate the antibody responses to serogroups A, C, Y, and W-135 in serum specimens collected 6 days post-vaccination in a subset of study population. Observational Objective: \- To describe the rates of immediate reactions, solicited injection-site and systemic reactions, unsolicited adverse events and serious adverse events following vaccination.

Detailed description

All participants will receive one dose of Menactra vaccine at their first clinic visit. There will be a telephone safety follow-up contact at six months post-vaccination.

Conditions

• Meningitis
• Meningococcal Infection

Interventions

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

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-06-01
• Completion: 2012-12-01
• First posted: 2011-09-28
• Last updated: 2014-11-18
• Results posted: 2014-11-18

Locations

15 sites across 1 country: United States