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

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: Genital Warts; Cervical Cancer

Treatments: Biological: Matching Placebo; Biological: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092534

2004_082

V501-015 (Other Identifier)

Details and patient eligibility

About

The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent cervical cancer.

Full description

In the 4-year Base Study (V501-015) (NCT00092534), participants were randomized in a 1:1 order to receive 3 doses of GARDASIL™ or matching placebo at Day 1, Month 2, and Month 6 and were assessed for efficacy, immunogenicity, and safety.

In the Base Study Extension (EXT) [V501-015-10], participants who received placebo or only 1 dose of GARDASIL™ in the Base Study, were given 3 doses of open-label GARDASIL™ at EXT Day 1, EXT Month 2, and EXT Month 6, and were followed to EXT Month 7. Participants who who received 2 doses of GARDASIL™ in the Base Study were given 1 dose of GARDASIL™ at EXT Day 1 and were followed for 15 days (day of vaccination plus 14 days).

In the 10-year Base Study Long-Term Follow-Up (LTFU) [V501-015-21] the effectiveness, immunogenicity and safety of GARDASIL™ was assessed during a period of 10 years following completion of the Base Study (V501-015) [14 years after the first dose of GARDASIL™] and, for some measures, the Base Study EXT (V501-015-10) [10 years after the first dose of GARDASIL™]. Participants from Denmark, Iceland, Norway and Sweden who participated in the Base Study were eligible to enroll in the LTFU. Effectiveness and safety was assessed by registry-based follow-up, and immunogenicity was assessed by serological testing at approximately Year 5 and Year 10 of the V501-015-21 LTFU.

An 8-year extension was added to the LTFU (V501-015-22] to continue the evaluation of the long-term effectiveness and immunogenicity of GARDASIL™. Effectiveness and safety will be assessed by registry-based follow-up, and immunogenicity will be assessed by serological testing at approximately Year 4 and Year 8 of the extension of the LTFU.

Enrollment: 12,167 patients

Sex: Female

Ages: 16 to 23 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for the Base Study:

• Healthy women with an intact uterus with lifetime history of 0-4 sexual partners

  --For Extension Phase:

• Participant received placebo or an incomplete vaccination series in the original study

  --For LTFU:

• Participant was randomized into the Base Study from Denmark, Iceland, Norway, or Sweden.

• Agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from National Registry Study Center and serum collection

Exclusion Criteria for the Base Study:

• 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

  --For LTFU Study:

• There were no exclusion criteria that did not overlap the inclusion criteria for this study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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12,167 participants in 2 patient groups, including a placebo group

Quadrivalent Human Papillomavirus (HPV) Vaccine

Experimental group

Description:

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.

Treatment:

Biological: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Biological: Matching Placebo