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

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Brief Title

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

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

Brief Summary

      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.
    



Study Type

Observational


Primary Outcome

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


Condition

Cervical Cancer

Intervention

V503

Study Arms / Comparison 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

4453

Start Date

January 22, 2016

Completion Date

January 1, 2024

Primary Completion Date

January 1, 2024

Eligibility Criteria

        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
      

Gender

Female

Ages

16 Years - 26 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, , 



Administrative Informations


NCT ID

NCT02653118

Organization ID

V503-021


Responsible Party

Sponsor

Study Sponsor

Merck Sharp & Dohme Corp.


Study Sponsor

Medical Director, Study Director, Merck Sharp & Dohme Corp.


Verification Date

January 2021