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Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil)(V501-015 AM5; EXT1; EXT2(AM1))

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00092534
First received: September 23, 2004
Last updated: October 17, 2012
Last verified: October 2012
History of Changes

September 23, 2004
October 17, 2012
June 2002
July 2007   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00092534 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil)(V501-015 AM5; EXT1; EXT2(AM1))
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)

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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Cervical Cancer
  • Genital Warts
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12167
January 2019
July 2007   (final data collection date for primary outcome measure)

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
Female
16 Years to 23 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00092534
2004_082, V501-015
No
Merck
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
October 2012

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