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Clinical Trials/NCT02934724
NCT02934724
Completed
Not Applicable

Impact of HPV Vaccine On The Prevalence Of Human Papillomavirus In Mouth And Vagina In Norway

Oslo University Hospital1 site in 1 country315 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Intraepithelial Neoplasia
Sponsor
Oslo University Hospital
Enrollment
315
Locations
1
Primary Endpoint
Vaginal and oral HPV-6, HPV-11, HPV-16 and HPV-18 prevalence
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The overall aim of the study is to assess the effect of school-based Human Papillomavirus (HPV) vaccination by comparing type-specific HPV prevalence between vaccinated and non-vaccinated women born in 1997. Women born in 1997, residence to Norway in 2009 (the year of vaccine initiation of the 1997-cohort) are invited to participate in the study.

Detailed Description

This cohort is amongst the first that was offered HPV vaccine in an organized vaccination programme globally. The women will be recruited through Facebook ads. The study will enable us to measure differences in the prevalence of HPV types in vagina and the mouth between vaccinated and non-vaccinated young women in Norway. The womens vaccination status will be validated by linkage to the Norwegian Immunisation Registry (SYSVAK) and their residence status will be validated through linkage to the Norwegian Population Registry.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
February 2017
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Espen Enerly

Dr Scient

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • Born in 1997
  • Resident of Norway in 2009

Exclusion Criteria

  • Born before or after 1997
  • Non-resident of Norway in 2009

Outcomes

Primary Outcomes

Vaginal and oral HPV-6, HPV-11, HPV-16 and HPV-18 prevalence

Time Frame: Within 2 months after self-collection of specimens

The differences in HPV types prevalence among vaccinees and non-vaccinees. HPV types will be assessed individually and combined.

Secondary Outcomes

  • Description of oral and vaginal overall genotype distribution among vaccinated and non-vaccination participants(Within 2 months after self-collection of specimens)

Study Sites (1)

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