Trial record 4 of 4195 for:    "Genital Diseases, Female"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00365716
First received: August 16, 2006
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Papillomavirus Infections
Genital Diseases, Female
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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Placebo-Controlled, Dose-Ranging Study of Quadrivalent HPV Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Subjects With Injection Site Adverse Experiences [ Time Frame: Days 1-5 following any vaccination visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1158
Study Start Date: May 2000
Study Completion Date: September 2009
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine
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
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 Name: V501
Experimental: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40
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
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 Name: V501
Experimental: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80
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
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 Name: V501
Experimental: Placebo (mcg) (Aluminum Adjuvant) 225
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
placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
Experimental: Placebo (mcg) (Aluminum Adjuvant) 450
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
placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.

  Eligibility

Ages Eligible for Study:   16 Years to 23 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365716

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00365716     History of Changes
Other Study ID Numbers: V501-007, 2006_516
Study First Received: August 16, 2006
Results First Received: May 19, 2010
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
HPV 6/11/16/18 infection and related genital disease

Additional relevant MeSH terms:
Genital Diseases, Female
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on April 17, 2014