NCT01304498

Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)

A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus (HPV) Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-old)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 9 Years – 15 Years
• Healthy volunteers: Accepted

Summary

Primary objective: • To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL. Secondary objectives: * To evaluate the tolerability of V503 in 9-15 year-old girls. * To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or GARDASIL.

Conditions

• Human Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	V503	9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine
BIOLOGICAL	GARDASIL	Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine

Timeline

• Start date: 2011-02-23
• Primary completion: 2011-12-20
• Completion: 2011-12-20
• First posted: 2011-02-25
• Last updated: 2018-12-14
• Results posted: 2017-08-22