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

NCT02653118 | Active Not Recruiting

• 2 other identifiers: V503-0212013-003549-40
• Study Type: observational
• Target: 4,453
• Locations: 0 countries
• Sites: N/A

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 is that V503 vaccine will remain effective for at least 30 years after the start of vaccination.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 in Cohort 1

  Up to 30 years after vaccination in V503-001 base study

Study Arms (2)

Cohort 1: V503 in the Base Study

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.

Biological: V503

Cohort 2: GARDASIL in the Base Study

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.

Biological: V503; Biological: GARDASIL

Interventions

V503 BIOLOGICAL

Cohort 1: V503 in the Base Study; Cohort 2: GARDASIL in the Base Study

GARDASIL BIOLOGICAL

Cohort 2: GARDASIL in the Base Study

Eligibility Criteria

• Age: 16 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants in the V503-021 long-term follow-up study received either the selected dose formulation of V503 or GARDASIL in the V503-001 (NCT00543543) base study

You may qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• Luxembourg A, Kjaer SK, Nygard M, Ellison MC, Group T, Marshall JB, Radley D, Saah A. Design of a long-term follow-up effectiveness, immunogenicity and safety study of women who received the 9-valent human papillomavirus vaccine. Contemp Clin Trials. 2017 Jan;52:54-61. doi: 10.1016/j.cct.2016.10.006. Epub 2016 Oct 21.

  PMID: 27777126 BACKGROUND

• Kjaer SK, Nygard M, Sundstrom K, Munk C, Berger S, Dzabic M, Fridrich KE, Waldstrom M, Sorbye SW, Bautista O, Group T, Luxembourg A. Long-term effectiveness of the nine-valent human papillomavirus vaccine in Scandinavian women: interim analysis after 8 years of follow-up. Hum Vaccin Immunother. 2021 Apr 3;17(4):943-949. doi: 10.1080/21645515.2020.1839292. Epub 2020 Dec 16.

  PMID: 33326342 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Condylomata Acuminata; Papillomavirus Infections

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvar Diseases; Vaginal Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 12, 2016
• Study Start: January 22, 2016
• Primary Completion (Estimated): January 1, 2040
• Study Completion (Estimated): January 1, 2040
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share