Clinical trial · Observational
Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Genital Warts | Condyloma Acuminatum | ALIAS | 0.90 |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GARDASIL | Biological | — | UNRESOLVED |
| V503 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Biological: V503
- label
- 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.
- interventionNames
- Biological: V503
- Biological: GARDASIL
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
- Maximum age
- 26 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDLuxembourg 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
- RESULTKjaer 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