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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Genital Diseases, Female; Papillomavirus Infections

Treatments: Biological: Placebo (mcg) (Aluminum Adjuvant) 450; Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20; 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)225

Study type: Interventional

Funder types: Industry

Identifiers

NCT00365716

V501-007

2006_516

Details and patient eligibility

About

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.

Enrollment: 1,158 patients

Sex: Female

Ages: 16 to 23 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,158 participants in 5 patient groups

Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine

Experimental group

Description:

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.

Treatment:

Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20

Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40

Experimental group

Description:

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.

Treatment:

Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40

Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80

Experimental group

Description:

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.

Treatment:

Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80

Placebo (mcg) (Aluminum Adjuvant) 225

Experimental group

Description:

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.

Treatment:

Biological: Placebo (mcg) (Aluminum Adjuvant)225

Placebo (mcg) (Aluminum Adjuvant) 450

Experimental group

Description:

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.

Treatment:

Biological: Placebo (mcg) (Aluminum Adjuvant) 450