NCT00260039

Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)

A Randomized, International, Double-Blinded (With In-House Blinding), GARDASIL-Controlled, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) L1 Virus-like Particle (VLP) Vaccine Administered to 16- to 23- Year-Old Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 680 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 16 Years – 23 Years
• Healthy volunteers: Accepted

Summary

This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.

Conditions

• HPV
• Cervical Cancer
• Premalignancy Anogenital Warts

Interventions

Type	Name	Description
BIOLOGICAL	Comparator: Gardasil	0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6
BIOLOGICAL	Comparator: octavalent HPV Vaccine - dose formulation 1	0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
BIOLOGICAL	Comparator: octavalent HPV Vaccine - dose formulation 2	0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
BIOLOGICAL	Comparator: octavalent HPV Vaccine - dose formulation 3	0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2005-12-01
• Last updated: 2015-06-08