Dose Comparison Study of Menactra® in US Children

Phase 2

Completed

• Conditions: Neisseria Meningitidis; Meningitis; Meningococcal Infection

• Registration Number: NCT00700635
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children.

Primary Objective:

To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.

Detailed Description

This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.

Study Timeline

• Study First Submitted: 2008-05-07
• Study Start: 2008-06
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Primary Completion: 2009-05
• Study Completion: 2009-10
• Disposition First Submitted: 2010-09-02
• Disposition First Submitted QC: 2010-10-04
• Disposition First Posted: 2010-10-06
• Results First Submitted: 2010-12-11
• Results First Submitted QC: 2010-12-11
• Results First Posted: 2010-12-23
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 333

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination	30 days post-vaccination	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.	30 days post-vaccination	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination	7 days post-vaccination 2	Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination	7 days post-vaccination 1	Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination	30 days post-vaccination	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)