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Trial record 1 of 1 for:    Espen enerly | Norway
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Impact of HPV Vaccine On The Prevalence Of HPV In Norway

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ClinicalTrials.gov Identifier: NCT02934724
Recruitment Status : Completed
First Posted : October 17, 2016
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
University Hospital, Akershus
Information provided by (Responsible Party):
Espen Enerly, Oslo University Hospital

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.

Condition or disease Intervention/treatment
Cervical Intraepithelial Neoplasia Cervical Cancer Oropharyngeal Cancer Procedure: Self sample from vagina Procedure: Self sample from the oral cavity Other: Questionnaire

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.

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Study Type : Observational
Actual Enrollment : 315 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Impact of HPV Vaccine On The Prevalence Of Human Papillomavirus In Mouth And Vagina In Norway
Actual Study Start Date : November 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Description of oral and vaginal overall genotype distribution among vaccinated and non-vaccination participants [ Time Frame: Within 2 months after self-collection of specimens ]

Biospecimen Retention:   Samples With DNA
Self samples from vagina and the oral cavity


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 20 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women resident to Norway in 2009
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

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): NCT02934724


Locations
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Norway
Oslo University Hospital, Cancer Registry of Norway
Oslo, Norway, 0379
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Akershus
Investigators
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Principal Investigator: Espen Enerly, Dr Scient Oslo University Hospital
Study Director: Giske Ursin, Dr.Med Oslo University Hospital

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Responsible Party: Espen Enerly, Dr Scient, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02934724    
Other Study ID Numbers: 2014/2333
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Espen Enerly, Oslo University Hospital:
HPV vaccines
HPV-6
HPV-11
HPV-16
HPV-18
Gardasil
Additional relevant MeSH terms:
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Cervical Intraepithelial Neoplasia
Oropharyngeal Neoplasms
Neoplasms by Site
Neoplasms
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs