Effectiveness Study of Gardasil on Condyloma
Gardasil® Population-Based Condyloma Effectiveness Study In Swedish Women Including Condyloma Incidence Estimations For Swedish Men And Women
1 other identifier
observational
500,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 17, 2011
CompletedFirst Posted
Study publicly available on registry
March 14, 2012
CompletedMarch 18, 2013
March 1, 2013
4.5 years
August 17, 2011
March 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Cases of condyloma post vaccination
1 year follow-up
Study Arms (1)
HPV vaccinated, non-vaccinated
Individuals born between 1989 and 1996. HPV-vaccinated will be compared to non-vaccinated in regards to condyloma status post vaccination.
Eligibility Criteria
Historically prospective study of population-based nationwide cohorts.
You may qualify if:
- Individuals born 1989-1996
You may not qualify if:
- Individual vaccinated with Cervarix
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lisen Arnheim Dahlstromlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
Stockholm, 17177, Sweden
Related Publications (1)
Leval 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: 23486550RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisen Arnheim-Dahlström, PhD
Karolinska Institutet, Department of Medical Epidemiology and Biostatistics, Sweden
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 17, 2011
First Posted
March 14, 2012
Study Start
June 1, 2006
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
March 18, 2013
Record last verified: 2013-03