Impact of HPV Vaccine On The Prevalence Of HPV In Norway

December 10, 2020 updated by: Espen Enerly, Oslo University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

315

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0379
        • Oslo University Hospital, Cancer Registry of Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 20 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women resident to Norway in 2009

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaccinated

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
Procedure: Self sample from vagina
Self sample using The Rover's Evalyn Brush
Procedure: Self sample from the oral cavity
Self sample using COPAN FloqSwab
Other: Questionnaire
Questionnaire about vaccination status and sexual behaviour
Un-vaccinated

Women born in 1997, resident to Norway in 2009, not 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
Procedure: Self sample from vagina
Self sample using The Rover's Evalyn Brush
Procedure: Self sample from the oral cavity
Self sample using COPAN FloqSwab
Other: Questionnaire
Questionnaire about vaccination status and sexual behaviour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 2 months after self-collection of specimens

Secondary Outcome Measures

Outcome Measure
Time Frame
Description of oral and vaginal overall genotype distribution among vaccinated and non-vaccination participants
Time Frame: Within 2 months after self-collection of specimens
Within 2 months after self-collection of specimens

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University Hospital, Akershus

Investigators

  • Principal Investigator: Espen Enerly, Dr Scient, Oslo University Hospital
  • Study Director: Giske Ursin, Dr.Med, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (Estimate)

October 17, 2016

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/2333

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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