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

Phase 2

Completed

• Conditions: Meningococcemia; Meningitis
• Interventions: Biological: Haemophilus Influenzae Type b (Hib) vaccine; Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

• Registration Number: NCT00771849
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2004-03
• Study Completion: 2004-05
• Study First Submitted: 2008-10-13
• Study First Submitted QC: 2008-10-13
• Study First Posted: 2008-10-15
• Results First Submitted: 2009-03-16
• Results First Submitted QC: 2009-03-16
• Results First Posted: 2009-04-24
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hiberix® Vaccine Group	Haemophilus Influenzae Type b (Hib) vaccine	Participants receiving Haemophilus Influenzae Type b (Hib) vaccine
Menactra® Vaccine Group	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	Participants receiving the tetravalent (A, C, Y, and W 135) meningococcal diphtheria toxoid conjugate vaccine

Primary Outcome Measures

Name	Time	Method
Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.	Day 0 (before) and 28 days post-vaccination

Secondary Outcome Measures

Name	Time	Method
Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.	28 days post-vaccination