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

August 25, 2004
March 31, 2014
June 2004
May 2009   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00090220 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
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
Not Provided
 
A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501) in Women (V501-019)
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Healthy
  • Papillomavirus Infection
  • Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Gardasil intramuscular injection in three 0.5 mL doses over 6 months.
  • Biological: Comparator: Placebo
    Placebo intramuscular injection in three 0.5 mL doses over 6 months.
  • Experimental: qHPV Vaccine
    Gardasil
    Intervention: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
  • Placebo Comparator: Placebo
    Intervention: Biological: Comparator: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3819
April 2016
May 2009   (final data collection date for primary outcome measure)

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
Female
24 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00090220
V501-019, 2004_013
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

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