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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092534
First received: September 23, 2004
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

The primary purpose of the study is to determine if Gardasil (V501) an investigational vaccine with 4 components is able to prevent cervical cancer.


Condition Intervention Phase
Cervical Cancer
Genital Warts
Biological: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
Biological: Matching Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Subjects With Anti-HPV 6 Titer >/= 20 mMU/mL [ Time Frame: Week 4 Postdose 3 (4 weeks after 3rd vaccine dose) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 24 mMU/mL


Enrollment: 12167
Study Start Date: June 2002
Estimated Study Completion Date: January 2019
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
Duration of Treatment: 6 months
Other Name: V501
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.
Biological: Matching Placebo
Matching Placebo to Quadrivalent Human Papillomavirus Vaccine

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092534

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092534     History of Changes
Other Study ID Numbers: V501-015, 2004_082
Study First Received: September 23, 2004
Results First Received: July 20, 2009
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cervical Intraepithelial Neoplasia
Uterine Cervical Neoplasms
Carcinoma
Carcinoma in Situ
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014