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Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil)(V501-015)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00092534
Recruitment Status : Completed
First Posted : September 28, 2004
Results First Posted : November 26, 2009
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 23, 2004
First Posted Date  ICMJE September 28, 2004
Results First Submitted Date July 20, 2009
Results First Posted Date November 26, 2009
Last Update Posted Date February 21, 2018
Actual Study Start Date  ICMJE June 14, 2002
Actual Primary Completion Date July 31, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2010)
Tolerability; Incidence of the Composite Endpoint of HPV 16 or HPV 18 Related CIN2/3 or Invasive Cervical Carcinoma After Completion of the Vaccination Series for Relevant HPV Type [ Time Frame: Follow-up through end of study (4 years) ]
Tolerability = Number of subjected affected. Incidence Rate per person-years of follow-up. The tolerability objective was to demonstrate that Gardasil is generally well tolerated by females aged 16-23. The relevant data are presented in the Reported Adverse Events section. No formal statistical hypothesis testing were performed for this objective.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00092534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2010)
  • Subjects With Anti-HPV 6 Titer >/= 20 mMU/mL [ Time Frame: Week 4 Postdose 3 (4 weeks after 3rd vaccine dose) ]
    Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 20 mMU/mL
  • Subjects With Anti-HPV 11 Titer >/= 16 mMU/mL [ Time Frame: Week 4 Postdose 3 ]
    Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 16 mMU/mL
  • Subjects With Anti-HPV 16 Titer >/= 20 mMU/mL [ Time Frame: Week 4 Postdose 3 ]
    Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 20mMU/mL
  • Subjects With Anti-HPV 18 Titer >/= 24 mMU/mL [ Time Frame: Week 4 Postdose 3 ]
    Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 24 mMU/mL
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil)(V501-015)
Official Title  ICMJE A Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety Immunogenicity and Efficacy on the Incidence of HPV 16/18-Related CIN2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18,) L1 Virus-Like Particle (VLP) Vaccine (V501, Gardasil) in 16- to 23-Year Old Women - The F.U.T.U.R.E. II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)
Brief Summary The primary purpose of the study is to determine if Gardasil (V501) an investigational vaccine with 4 components is able to prevent cervical cancer.
Detailed Description

The original base study (V501-015) (NCT00092534) was extended in protocol V501-015-10. Subjects in the placebo arm of the base study were given 3 doses of open-label GARDASIL™ (V501) at Extension (EXT) Day 1, EXT Month 2 and EXT Month 6 and were followed to EXT Month 7. Subjects who received only 1 dose of GARDASIL™ in the base study were given 3 doses of open-label GARDASIL™ (V501) at Extension (EXT) Day 1, EXT Month 2 and EXT Month 6 and were followed to EXT Month 7. Subjects who received 2 doses of GARDASIL™ in the base study were given only 1 dose of GARDASIL™ at EXT Day 1 and were followed for 15 days (day of vaccination plus 14 days).

A second extension study, V501-015-20, will assess the effectiveness, immunogenicity and safety of GARDASIL™ during a period of 10-14 years following completion of the base study (V501-015) or the V501-015-10 extension. Subjects from Denmark, Iceland, Norway and Sweden who participated in the base study were eligible to enroll. Effectiveness and safety will be assessed by registry-based follow-up. Immunogenicity will be assessed by serological testing at approximately Year 5 and Year 10 of the V501-015-20 extension, respectively.

Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Cervical Cancer
  • Genital Warts
Intervention  ICMJE
  • Biological: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
    Duration of Treatment: 6 months
    Other Name: V501
  • Biological: Matching Placebo
    Matching Placebo to Quadrivalent Human Papillomavirus Vaccine
Study Arms
  • Experimental: Quadrivalent Human Papillomavirus (HPV) Vaccine
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
    Intervention: Biological: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
  • Placebo Comparator: Placebo
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
    Intervention: Biological: Matching Placebo
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: October 15, 2009)
12167
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date March 31, 2017
Actual Primary Completion Date July 31, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy women with an intact uterus with lifetime history of 0-4 sexual partners

    --For Extension Phase:

  • Subject received placebo or an incomplete vaccination series in the original study

Exclusion Criteria:

  • Prior Human Papilloma Virus (HPV) vaccination
  • Prior abnormal Paps
  • Prior history of genital warts

    --For Extension Phase:

  • Prior complete HPV vaccination series
  • Subject lives in a country in which Gardasil is approved and is within the age range of the local labeling for Gardasil
Sex/Gender
Sexes Eligible for Study: Female
Ages 16 Years to 23 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00092534
Other Study ID Numbers  ICMJE V501-015
2004_082
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement 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 January 2018

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