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.

NCT00444951 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 3
Status	COMPLETED
Enrolment	450
Start date	2007-02
Completion	2009-02

Conditions

• Neisseria Meningitidis
• Meningococcal Infections

Interventions

• Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine
• Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine
• Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine

Primary outcomes

• Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination — Baseline (Day 0) and Day 28 after vaccination

Countries

Saudi Arabia