Impact of HPV Vaccine On The Prevalence Of HPV In Norway

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Cervical intraepithelial neoplasia
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Brief Title

Impact of HPV Vaccine On The Prevalence Of HPV In Norway

Official Title

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

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.

Study Type

Observational

Primary Outcome

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

Secondary Outcome

 Description of oral and vaginal overall genotype distribution among vaccinated and non-vaccination participants

Condition

Cervical Intraepithelial Neoplasia

Intervention

Self sample from vagina

Study Arms / Comparison Groups

 Vaccinated
Description:  Women born in 1997, resident to Norway in 2009, vaccinated by the quadrivalent HPV vaccine.
Interventions:
Self sample from vagina using Rover's Evalyn Brush
Self sample from the oral cavity using COPAN's FloqSwab
Questionnaire

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

315

Start Date

November 2016

Completion Date

February 2017

Primary Completion Date

February 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Female

          -  Born in 1997

          -  Resident of Norway in 2009

        Exclusion Criteria:

          -  Male

          -  Born before or after 1997

          -  Non-resident of Norway in 2009

Gender

Female

Ages

18 Years - 20 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Espen Enerly, Dr Scient, ,

Location Countries

Norway

Location Countries

Norway

Administrative Informations

NCT ID

NCT02934724

Organization ID

2014/2333

Responsible Party

Principal Investigator

Study Sponsor

Oslo University Hospital

Collaborators

 University Hospital, Akershus

Study Sponsor

Espen Enerly, Dr Scient, Principal Investigator, Oslo University Hospital

Verification Date

December 2020