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Effectiveness Study of Gardasil on Condyloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01553994
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : March 18, 2013
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Lisen Arnheim Dahlstrom, Karolinska Institutet

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.


Condition or disease
Condyloma Genital Warts

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Study Type : Observational
Actual Enrollment : 500000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Group/Cohort
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.



Primary Outcome Measures :
  1. Cases of condyloma post vaccination [ Time Frame: 1 year follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Historically prospective study of population-based nationwide cohorts.
Criteria

Inclusion Criteria:

  • Individuals born 1989-1996

Exclusion Criteria:

  • Individual vaccinated with Cervarix

Information from the National Library of Medicine

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


Locations
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Sweden
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
Stockholm, Sweden, 17177
Sponsors and Collaborators
Lisen Arnheim Dahlstrom
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Lisen Arnheim-Dahlström, PhD Karolinska Institutet, Department of Medical Epidemiology and Biostatistics, Sweden
Publications of Results:
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Responsible Party: Lisen Arnheim Dahlstrom, Assistant Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01553994    
Other Study ID Numbers: condylomaeffect001
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Condylomata Acuminata
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases