A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501) in Women (V501-019)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00090220
First received: August 25, 2004
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

This study is to assess the tolerability and efficacy of a vaccine being evaluated to reduce the incidence of human papillomavirus (HPV) infection and disease (external genital warts and vulvar, vaginal, and cervical cancer) in women.


Condition Intervention Phase
Healthy
Papillomavirus Infection
Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Biological: Comparator: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Combined Incidence of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, Vulvar Intraepithelial Neoplasia (VIN), Vaginal Intraepithelial Neoplasia (VaIN), Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, AIS, and Cervical Cancer [ Time Frame: Base Study: through Month 48 ] [ Designated as safety issue: No ]
    HPV 6/11/16/18: The four types of HPV (types 6/11/16/18) were determined by polymerase chain reaction (PCR) testing

  • Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) [ Time Frame: Base Study: through Month 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Combined Incidence of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Adenocarcinoma In Situ (AIS), and Cervical Cancer [ Time Frame: Base Study: through Month 48 ] [ Designated as safety issue: No ]
    HPV 6/11: The two types of HPV (types 6/11) were determined by PCR testing

  • Combined Incidence of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer [ Time Frame: Base Study: through Month 48 ] [ Designated as safety issue: No ]
    This outcome measure was not analyzed because of diminished interest by experts in composite efficacy endpoints associated with these HPV types


Other Outcome Measures:
  • Combined Incidence of HPV 16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer [ Time Frame: Base Study: through Month 48 ] [ Designated as safety issue: No ]
    HPV 16/18: The two types of HPV (types 16/18) were determined by PCR testing


Enrollment: 3819
Study Start Date: June 2004
Estimated Study Completion Date: April 2016
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: qHPV Vaccine
Gardasil
Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Gardasil intramuscular injection in three 0.5 mL doses over 6 months.
Placebo Comparator: Placebo Biological: Comparator: Placebo
Placebo intramuscular injection in three 0.5 mL doses over 6 months.

Detailed Description:

The base study (V501-019) encompassed Day 1 through Month 7, during which time participants received randomly assigned Gardasil™ (qHPV vaccine) or placebo at Day 1, Month 2 and Month 6. Base study follow-up continued through Month 48.

The base study was extended in protocol V501-019-10 (EXT1). Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.

A Long Term Follow-Up (LTFU) extension study V501-019-20 (EXT2) will observe the long term safety, effectiveness, and immunogenicity of GARDASIL™ in 1,600 women who participated in the base protocol in Colombia. Data will be collected over a period of 6-10 years following subjects' enrollment in the original base protocol.

  Eligibility

Ages Eligible for Study:   24 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No history of genital warts, VIN, or VaIN
  • Not pregnant and agrees to use effective contraception through Month 7 of the study
  • Additional criteria will be discussed with you by the physician

Exclusion Criteria:

  • Pregnant
  • Concurrently enrolled in a clinical study involving collection of cervical specimens
  • Previously received any HPV vaccine
  • History of severe allergic reaction that required medical intervention
  • Received any immune globulin or blood-derived products within 3 months prior to the first study injection
  • History of splenectomy, known immune disorders, or receiving immunosuppressives
  • Immunocompromised or diagnosed with HIV infection
  • Known thrombocytopenia or any coagulation disorders that could contraindicate intramuscular injections
  • History of recent or ongoing alcohol or drug abuse
  • Prior treatment for genital warts, VIN, or VaIN
  • History of cervical disease (ie, surgical treatment for cervical lesions)
  • Hysterectomy
  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: NCT00090220

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: NCT00090220     History of Changes
Other Study ID Numbers: V501-019, 2004_013
Study First Received: August 25, 2004
Results First Received: October 30, 2009
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on July 20, 2014