Dose-Ranging Study of Quadrivalent Human Papillomavirus (HPV) (Types 6,11,16,18) L1 Virus-Like Particle (VLP) Vaccine (V501-007)(COMPLETED)

Phase 2

Completed

• Conditions: Papillomavirus Infections; Genital Diseases, Female
• Interventions: Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40; Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80; Biological: Placebo (mcg) (Aluminum Adjuvant) 450; Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20; Biological: Placebo (mcg) (Aluminum Adjuvant)225

• Registration Number: NCT00365716
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study was conducted in 2 parts. Part A was a randomized, double-blind, placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a randomized, double-blind (operating under in-house blinding procedures), placebo-controlled, multicenter, dose-ranging study.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2004-05
• Study First Submitted: 2006-08-16
• Study First Submitted QC: 2006-08-16
• Study First Posted: 2006-08-17
• Study Completion: 2009-09
• Results First Submitted: 2010-05-19
• Results First Submitted QC: 2010-07-06
• Results First Posted: 2010-08-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1158

Inclusion Criteria

• Healthy females 16 to 23 years of age
• Not pregnant at enrollment and must have agreed to use effective contraception through Month 7 of the study
• Lifetime history of 0 to 4 male sexual partners (individuals with whom penetrative sexual intercourse occurred)

Exclusion Criteria

• No prior receipt of an Human Papillomavirus (HPV) vaccine
• No receipt of inactivated or recombinant vaccines within 14 days prior to enrollment or receipt of live vaccines within 21 days prior to enrollment
• No prior abnormal Pap test showing squamous intraepithelial lesion (SIL) or biopsy showing cervical intraepithelial neoplasia (CIN)
• No prior history of genital warts or treatment for genital warts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40	Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40	The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80	Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80	The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
Placebo (mcg) (Aluminum Adjuvant) 450	Placebo (mcg) (Aluminum Adjuvant) 450	The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine	Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20	The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
Placebo (mcg) (Aluminum Adjuvant) 225	Placebo (mcg) (Aluminum Adjuvant)225	The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Injection Site Adverse Experiences	Days 1-5 following any vaccination visit

Secondary Outcome Measures

Name	Time	Method
Incidence of HPV 6-, 11-, 16- or 18-related Persistent Infection or Disease (Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Adenocarcinoma in Situ, Cervical Cancer, and Genital Warts)	Through 36 Months