Overview

This trial is active, not recruiting.

Conditions cervical cancer, genital warts
Treatments gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine, matching placebo
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date June 2002
End date July 2007
Trial size 12167 participants
Trial identifier NCT00092534, 2004_082, V501-015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
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.
gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine V501
Duration of Treatment: 6 months
(Placebo Comparator)
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.
matching placebo
Matching Placebo to Quadrivalent Human Papillomavirus Vaccine

Primary Outcomes

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)

Secondary Outcomes

Measure
Subjects With Anti-HPV 6 Titer >/= 20 mMU/mL
time frame: Week 4 Postdose 3 (4 weeks after 3rd vaccine dose)
Subjects With Anti-HPV 11 Titer >/= 16 mMU/mL
time frame: Week 4 Postdose 3
Subjects With Anti-HPV 16 Titer >/= 20 mMU/mL
time frame: Week 4 Postdose 3
Subjects With Anti-HPV 18 Titer >/= 24 mMU/mL
time frame: Week 4 Postdose 3

Eligibility Criteria

Female participants from 16 years up to 23 years old.

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

Additional Information

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)
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..