Immunology and Safety of Menactra® in Children in Saudi Arabia

Phase 3

Completed

• Conditions: Meningitis; Meningococcemia

• Registration Number: NCT00539032
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This study will be conducted among children in Saudi Arabia who previously received two doses of A, C, Y, W-135 polysaccharide vaccine before the age of 2 years, and in meningococcal vaccine-naïve children (Control Group). This study will evaluate the administration of Menactra® in terms of the serum bactericidal antibody it induces in the two study groups. Safety of Menactra® vaccine will be described.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-02
• Study First Submitted QC: 2007-10-02
• Study First Posted: 2007-10-03
• Primary Completion: 2008-08
• Study Completion: 2009-02
• Results First Submitted: 2009-09-09
• Results First Submitted QC: 2010-12-22
• Results First Posted: 2011-01-24
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.	Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination
Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.	Day 28 Post-vaccination