Clinical Trial: Immunology and Safety of Menactra® in Children in Saudi Arabia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of the Response to a Single Dose of Menactra® in Children Aged 5 to 8 Years Who Had Previously Received Two Doses of Quadrivalent (A, C, Y, W-135) Meningococcal Polysaccharide Vaccine
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 Summary:
Sponsor: Sanofi Pasteur, a Sanofi Company
Current Primary Outcome:
- Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. [ Time Frame: 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. [ Time Frame: Day 28 Post-vaccination ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sanofi
Dates:
Date Received: October 2, 2007
Date Started: September 2007
Date Completion:
Last Updated: April 12, 2016
Last Verified: April 2016
