NCT00771849

Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children

Antibody Responses for Serogroup C After One Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine Versus a Non-meningococcal Control Vaccine in Children Who Have Previously Received a Monovalent Meningococcal C Conjugate Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Years – 4 Years
• Healthy volunteers: Accepted

Summary

The study investigated safety profile and the antibody responses to an experimental tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have received a monovalent meningococcal C conjugate vaccine at least one year previously. Primary objective: To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C in participants receiving Menactra® to the serogroup C antibody response in a control group of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28 days following vaccination.

Conditions

• Meningitis
• Meningococcemia

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	0.5 mL, Intramuscular
BIOLOGICAL	Haemophilus Influenzae Type b (Hib) vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2003-08-01
• Primary completion: 2004-03-01
• Completion: 2004-05-01
• First posted: 2008-10-15
• Last updated: 2016-04-14
• Results posted: 2009-04-24

Locations

2 sites across 1 country: United Kingdom