NCT00700713

Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26

Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® (Meningococcal [Groups A, C, Y, and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Three Years Earlier in Study MTA26

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Accepted

Summary

Study will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and age-matched Menactra naive participants. Objectives: * To assess the persistence of antibody responses three years after one or two doses of Menactra® vaccine in subjects who participated in study MTA26. * To describe the antibody responses to a single dose of Menactra® vaccine in subjects who had previously received one or two doses of Menactra® vaccine and in Menactra® vaccine-naïve subjects. * To describe the safety profile of a single dose of Menactra® vaccine in subjects.

Detailed description

Subjects that received Menactra® vaccine in study MTA26 (NCT00643916) and age-matched Menactra naive participants will receive a single dose of Menactra® on Day 0. They will be evaluated for immunogenicity and safety post-vaccination.

Conditions

• Meningitis
• Meningococcemia

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal polysaccharide diphtheria toxoid conjugate	0.5 mL, IM
BIOLOGICAL	Meningococcal polysaccharide diphtheria toxoid conjugate	0.5 mL, IM
BIOLOGICAL	Meningococcal polysaccharide diphtheria toxoid conjugate	0.5 mL, IM

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-02-01
• Completion: 2009-03-01
• First posted: 2008-06-19
• Last updated: 2016-02-15
• Results posted: 2016-02-15

Locations

13 sites across 1 country: United States