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

Study Overview
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Brief Summary
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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.

Official Title
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A Placebo-Controlled, Dose-Ranging Study of Quadrivalent HPV Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women

Conditions
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Papillomavirus Infections, Genital Diseases, Female

Intervention / Treatment
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* 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
* Biological: Placebo (mcg) (Aluminum Adjuvant) 450


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 23 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine<br>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. | Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20<br>* 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.<br>* Other names: V501;|
| Experimental: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40<br>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. | Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40<br>* 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.<br>* Other names: V501;|
| Experimental: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80<br>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. | Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80<br>* 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.<br>* Other names: V501;|
| Experimental: Placebo (mcg) (Aluminum Adjuvant) 225<br>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. | Biological: Placebo (mcg) (Aluminum Adjuvant)225<br>* placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.<br>|
| Experimental: Placebo (mcg) (Aluminum Adjuvant) 450<br>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. | Biological: Placebo (mcg) (Aluminum Adjuvant) 450<br>* placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Injection Site Adverse Experiences |  | Days 1-5 following any vaccination visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV 6/11/16/18 infection and related genital disease