NCT00539032

Immunology and Safety of Menactra® in Children in Saudi Arabia

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 Before Age 2 Years in Saudi Arabia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Accepted

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.

Conditions

• Meningitis
• Meningococcemia

Interventions

Type	Name	Description
BIOLOGICAL	Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	0.5 mL, Intramuscular
BIOLOGICAL	Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	0.5 mL, Intramuscular

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-08-01
• Completion: 2009-02-01
• First posted: 2007-10-03
• Last updated: 2016-04-14
• Results posted: 2011-01-24

Locations

4 sites across 1 country: Saudi Arabia