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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)

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ClinicalTrials.gov Identifier: NCT00365716
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : August 3, 2010
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE August 16, 2006
First Posted Date  ICMJE August 17, 2006
Results First Submitted Date  ICMJE May 19, 2010
Results First Posted Date  ICMJE August 3, 2010
Last Update Posted Date October 7, 2015
Study Start Date  ICMJE May 2000
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2010)
Number of Subjects With Injection Site Adverse Experiences [ Time Frame: Days 1-5 following any vaccination visit ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2006)
Safety and tolerability
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2006)
Through 36 Months: HPV PCR positivity; incidence of CIN, VIN, VaIN, AIS, cervical cancer, and genital warts
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Ranging Study of Quadrivalent Human Papillomavirus (HPV) (Types 6,11,16,18) L1 Virus-Like Particle (VLP) Vaccine (V501-007)(COMPLETED)
Official Title  ICMJE A Placebo-Controlled, Dose-Ranging Study of Quadrivalent HPV Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Papillomavirus Infections
  • Genital Diseases, Female
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2010)
1158
Original Enrollment  ICMJE
 (submitted: August 16, 2006)
1045
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 23 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00365716
Other Study ID Numbers  ICMJE V501-007
2006_516
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2015

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