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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)

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, 2014
Last verified: November 2014

August 16, 2006
November 4, 2014
May 2000
May 2004   (final data collection date for primary outcome measure)
Number of Subjects With Injection Site Adverse Experiences [ Time Frame: Days 1-5 following any vaccination visit ] [ Designated as safety issue: Yes ]
Safety and tolerability
Complete list of historical versions of study NCT00365716 on ClinicalTrials.gov Archive Site
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 ]
Through 36 Months: HPV PCR positivity; incidence of CIN, VIN, VaIN, AIS, cervical cancer, and genital warts
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Papillomavirus Infections
  • Genital Diseases, Female
  • 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
  • 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
  • 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
  • Biological: Placebo (mcg) (Aluminum Adjuvant)225
    placebo containing 225 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.
  • 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.
    Intervention: Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20
  • 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.
    Intervention: Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40
  • 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.
    Intervention: Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80
  • 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.
    Intervention: Biological: Placebo (mcg) (Aluminum Adjuvant)225
  • 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.
    Intervention: Biological: Placebo (mcg) (Aluminum Adjuvant) 450

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1158
September 2009
May 2004   (final data collection date for primary outcome measure)

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
Female
16 Years to 23 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00365716
V501-007, 2006_516
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP