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Completed

NCT Number: NCT00365716

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

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.

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Key information

Conditions

Papillomavirus Infections Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

16 year–23 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

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.

Other names: V501

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

Biological

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.

Other names: V501

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

Biological

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.

Other names: V501

Placebo (mcg) (Aluminum Adjuvant)225

Biological

placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.

Placebo (mcg) (Aluminum Adjuvant) 450

Biological

placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.

Primary outcomes

  1. Number of Subjects With Injection Site Adverse Experiences

    Time frame: Days 1-5 following any vaccination visit

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2004
Study completion
2009
First posted
Aug 17, 2006
Registry last updated
Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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