Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021)
This trial is active, not recruiting.
|Conditions||cervical cancer, vulvar cancer, vaginal cancer, genital warts, human papillomavirus infection|
|Sponsor||Merck Sharp & Dohme Corp.|
|Start date||January 2016|
|End date||January 2024|
|Trial size||4453 participants|
|Trial identifier||NCT02653118, V503-021|
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 being tested is that V503 vaccine will remain effective for at least 14 years after the start of vaccination.
Combined Incidence of HPV Type 16, 18, 31, 33, 45, 52, or 58-related Cervical Intraepithelial Neoplasia (CIN) Grades 2 or 3, Adenocarcinoma In Situ (AIS), and Cervical Cancer
time frame: Up to 16 years after vaccination in V503-001 base study
Female participants from 16 years up to 26 years old.
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 - Age 16 to 26 years at the time of enrollment in study V503-001 - 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
|Official title||A Registry-Based Extension of Protocol V503-001 in Countries With Centralized Cervical Cancer Screening Infrastructures to Evaluate the Long-Term Effectiveness, Immunogenicity, and Safety of Multivalent Human Papillomavirus (HPV) L1 Virus- Like Particle (VLP) Vaccine as Administered to 16- to 26- Year- Old Women|
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