Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021)

Merck Sharp & Dohme (MSD)

Status: Active, not recruiting

Conditions: Genital Warts; Vulvar Cancer; Vaginal Cancer; Human Papillomavirus Infection; Cervical Cancer

Treatments: Biological: V503; Biological: GARDASIL

Study type: Observational

Funder types: Industry

Identifiers

NCT02653118

2013-003549-40 (EudraCT Number)

V503-021

Details and patient eligibility

About

Protocol V503-021 is a long-term follow-up study of the V503-001 base study (NCT00543543) to evaluate the safety, immunogenicity, and long-term effectiveness of V503 vaccine in preventing cervical cancer and related precancers caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58. Because of the high retention of V503-001 participants from the Nordic countries, and the highly efficient screening and surveillance system there, study V503-021 will evaluate only participants from V503-001 sites in Denmark, Norway, and Sweden. The hypothesis is that V503 vaccine will remain effective for at least 30 years after the start of vaccination.

Enrollment: 4,453 estimated patients

Sex: Female

Ages: 16 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Randomized into the V503-001 (NCT00543543) study from a Denmark, Norway, or Sweden site and participated in the study by receiving either the selected dose formulation of V503 or GARDASIL
• Agrees to allow passive follow-up, analysis of biopsy specimens, future contact from the National Registry Study Centers, and serum collection

Exclusion criteria

• There are no exclusion criteria

Trial design

4,453 participants in 2 patient groups

Cohort 1: V503 in the Base Study

Description:

Participants received the selected dose formulation of V503 (0.5 mL in a 3-dose regimen) from a Denmark, Norway, or Sweden site in the base study (V503-001, NCT00543543). No study vaccination will be administered in study V503-021.

Treatment:

Biological: V503

Cohort 2: GARDASIL in the Base Study

Description:

Participants received GARDASIL (0.5 mL in a 3-dose regimen) from a Denmark, Norway, or Sweden site in the base study (V503-001, NCT00543543) and were offered the selected dose formulation of V503 (0.5 mL in a 3-dose regimen) at the conclusion of the base study. V503 vaccination was voluntary and not a condition for inclusion in Cohort 2. No study vaccination will be administered in study V503-021.

Treatment:

Biological: GARDASIL

Biological: V503