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

NCT02653118 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 4453

Last updated 2024-11-12

No results posted yet for this study

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

Interventions

BIOLOGICAL

V503

BIOLOGICAL

GARDASIL

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Eligibility

Min Age
16 Years
Max Age
26 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-22
Primary Completion
2040-01-01
Completion
2040-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02653118 on ClinicalTrials.gov