Effectiveness Study of Gardasil on Condyloma
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|ClinicalTrials.gov Identifier: NCT01553994|
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : March 18, 2013
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.
|Condition or disease|
|Condyloma Genital Warts|
|Study Type :||Observational|
|Actual Enrollment :||500000 participants|
|Official Title:||Gardasil® Population-Based Condyloma Effectiveness Study In Swedish Women Including Condyloma Incidence Estimations For Swedish Men And Women|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
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.
- Cases of condyloma post vaccination [ Time Frame: 1 year follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553994
|Department of Medical Epidemiology and Biostatistics, Karolinska Institutet|
|Stockholm, Sweden, 17177|
|Principal Investigator:||Lisen Arnheim-Dahlström, PhD||Karolinska Institutet, Department of Medical Epidemiology and Biostatistics, Sweden|