NCT00988884

A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)

A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) Given Concomitantly With Menactra™ and Adacel™ in Preadolescents and Adolescents (11 to 15 Year Olds)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,241 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 11 Years – 15 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the tolerability and immunogenicity of administration of the first dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one month prior to administration of Menactra™ and Adacel™.

Conditions

• Human Papillomavirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	V503	V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6
BIOLOGICAL	Comparator: Menactra™ (Concomitant)	Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.
BIOLOGICAL	Comparator: Adacel™ (Concomitant)	Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.
BIOLOGICAL	Comparator: Menactra™ (Non-Concomitant)	Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.
BIOLOGICAL	Comparator: Adacel™ (Non-concomitant)	Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.

Timeline

• Start date: 2009-10-21
• Primary completion: 2011-02-22
• Completion: 2011-02-22
• First posted: 2009-10-02
• Last updated: 2018-12-14
• Results posted: 2015-01-13