NCT00444951

Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia

Evaluation of the Response to a Single Dose of Menactra® in Adolescents Aged 16 to 19 Years Who Previously Received One Dose of Quadrivalent (A, C, Y, W 135) and at Least One Dose of Bivalent (A, C) Meningococcal Polysaccharide Vaccine in Saudi Arabia.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 16 Years – 19 Years
• Healthy volunteers: Accepted

Summary

This study will be conducted among adolescents in Saudi Arabia who previously received one dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine. This study will evaluate the booster administration of Menactra® (Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine) compared with Mencevax® (Meningococcal A, C, Y, and W 135 Polysaccharide vaccine)in terms of their serum bactericidal antibody responses.

Conditions

• Neisseria Meningitidis
• Meningococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine	0.5 mL, Subcutaneous
BIOLOGICAL	Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-02-01
• Completion: 2009-02-01
• First posted: 2007-03-08
• Last updated: 2015-07-14
• Results posted: 2011-03-04

Locations

7 sites across 1 country: Saudi Arabia