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COMPLETEDPHASE2

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

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

NCT00365716•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

16 - 23 years

Sex

FEMALE

Healthy Volunteers

Yes

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

Key Dates

Start Date

May 1, 2000

Primary Completion Date

May 1, 2004

Completion Date

September 1, 2009

Last Updated

October 7, 2015

Enrollment

1,158

ACTUAL participants

Conditions

Papillomavirus InfectionsGenital Diseases, Female

Interventions

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

BIOLOGICAL

Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)

NCT04199689

Papillomavirus Infections

View study

COMPLETEDNA

Intervention for Human Papillomavirus Vaccine Acceptance in Mexican Mothers

NCT06854354

Papillomavirus InfectionsPapillomavirus Vaccines

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 7, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)

Intervention for Human Papillomavirus Vaccine Acceptance in Mexican Mothers

Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With HPV16 or HPV18 Infection of the Cervix

Impact of HPV Vaccination Against Cervical Lesions and Genital Warts in Colombia. an Ecological Assessment

Prevalence and Longitudinal Follow-up of Anal Lesions, HPV Infection and Associated Sexually Transmitted Infections Among Men Who Have Sex With Men in Togo.

Transrectal and 3D Transabdominal Ultrasound Compared to Vaginoscopy in Diagnosing Virgins With Genital Lesions