Impact of HPV Vaccine On The Prevalence Of HPV In Norway

NCT ID: NCT02934724

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

315 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-02-28

Brief Summary

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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

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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.

Conditions

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Cervical Intraepithelial Neoplasia Cervical Cancer Oropharyngeal Cancer

Keywords

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HPV vaccines HPV-6 HPV-11 HPV-16 HPV-18 Gardasil

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Self sample from vagina

Intervention Type PROCEDURE

Self sample using The Rover's Evalyn Brush

Self sample from the oral cavity

Intervention Type PROCEDURE

Self sample using COPAN FloqSwab

Questionnaire

Intervention Type OTHER

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

Self sample from vagina

Intervention Type PROCEDURE

Self sample using The Rover's Evalyn Brush

Self sample from the oral cavity

Intervention Type PROCEDURE

Self sample using COPAN FloqSwab

Questionnaire

Intervention Type OTHER

Questionnaire about vaccination status and sexual behaviour

Interventions

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Self sample from vagina

Self sample using The Rover's Evalyn Brush

Intervention Type PROCEDURE

Self sample from the oral cavity

Self sample using COPAN FloqSwab

Intervention Type PROCEDURE

Questionnaire

Questionnaire about vaccination status and sexual behaviour

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Akershus

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Espen Enerly

Dr Scient

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Espen Enerly, Dr Scient

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Giske Ursin, Dr.Med

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

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Oslo University Hospital, Cancer Registry of Norway

Oslo, , Norway

Site Status

Countries

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Norway

References

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PLOS ONE Staff. Correction: An observational study comparing HPV prevalence and type distribution between HPV-vaccinated and -unvaccinated girls after introduction of school-based HPV vaccination in Norway. PLoS One. 2019 Dec 12;14(12):e0226706. doi: 10.1371/journal.pone.0226706. eCollection 2019.

Reference Type BACKGROUND
PMID: 31830145 (View on PubMed)

Enerly E, Flingtorp R, Christiansen IK, Campbell S, Hansen M, Myklebust TA, Weiderpass E, Nygard M. An observational study comparing HPV prevalence and type distribution between HPV-vaccinated and -unvaccinated girls after introduction of school-based HPV vaccination in Norway. PLoS One. 2019 Oct 10;14(10):e0223612. doi: 10.1371/journal.pone.0223612. eCollection 2019.

Reference Type RESULT
PMID: 31600341 (View on PubMed)

Other Identifiers

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2014/2333

Identifier Type: -

Identifier Source: org_study_id