Clinical trial · Observational
Effectiveness Study of Gardasil on Condyloma
Gardasil® Population-Based Condyloma Effectiveness Study In Swedish Women Including Condyloma Incidence Estimations For Swedish Men And 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)
Overview and rationale: Through Swedish health care registers it is possible vaccine effectiveness. The overall aim is to develop tools for fast and reliable evaluation of vaccines focusing on effectiveness. In this study the investigators will assess the population impact on condyloma prescribed drugs after HPV-vaccination and to estimate the economic burden of hospitalizations due to condyloma. Genital warts (condyloma) are one of the most common sexually transmitted diseases in Sweden, estimated 20 000 identified cases per year, and are primarily treated with Podofyllotoxin and Immiquimod. One of the approved HPV vaccines also protects against condyloma. In clinical trials, this vaccine is safe and highly efficacious (90-100%) against persistent infection with HPV 6 and 11 and genital warts in women and men. However, these results are from clinical trials and do not answer the question weather the vaccine works when delivered, as it would be in the real world. By linkage between the Svevac, the patient register and the Drug prescription register the investigators can estimate the effectiveness of the HPV vaccine in preventing cases of condyloma in a defined population. Method and execution: This is a retrospective collection of data from Swedish health care registries where the study population will consist of persons who are HPV-vaccinated as well as a non-HPV-vaccinated control group (identified through the population-based register, matched on sex, age and living area). The primary statistical analysis will be a calculation of prescriptions of condyloma treatments after vaccination compared to the non-vaccinated control group.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Condyloma | Condyloma Acuminatum | ALIAS | 0.90 |
| Genital Warts | Condyloma Acuminatum | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- HPV vaccinated, non-vaccinated
- description
- Individuals born between 1989 and 1996. HPV-vaccinated will be compared to non-vaccinated in regards to condyloma status post vaccination.
Primary outcomes (1)
- measure
- Cases of condyloma post vaccination
- timeFrame
- 1 year follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals born 1989-1996 Exclusion Criteria: * Individual vaccinated with Cervarix
References
Publications (1)
- RESULTLeval A, Herweijer E, Ploner A, Eloranta S, Fridman Simard J, Dillner J, Young C, Netterlid E, Sparen P, Arnheim-Dahlstrom L. Quadrivalent human papillomavirus vaccine effectiveness: a Swedish national cohort study. J Natl Cancer Inst. 2013 Apr 3;105(7):469-74. doi: 10.1093/jnci/djt032. Epub 2013 Mar 13. PMID 23486550