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 LLC1,158 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,158

Conditions

Papillomavirus Infections Genital Diseases, Female

Interventions

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

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.

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

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 80/80/40/80BIOLOGICAL

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.

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 23 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Subjects With Injection Site Adverse Experiences

Time frame: Days 1-5 following any vaccination visit

Secondary Outcomes

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)

Time frame: Through 36 Months

Data from ClinicalTrials.gov

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