Impact of HPV Vaccine On The Prevalence Of HPV In Norway

Study Overview
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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.

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

Conditions
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Cervical Intraepithelial Neoplasia, Cervical Cancer, Oropharyngeal Cancer

Intervention / Treatment
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* Procedure: Self sample from vagina
* Procedure: Self sample from the oral cavity
* Other: Questionnaire


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaccinated<br>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<br>* Self sample using The Rover's Evalyn Brush<br>Procedure: Self sample from the oral cavity<br>* Self sample using COPAN FloqSwab<br>Other: Questionnaire<br>* Questionnaire about vaccination status and sexual behaviour<br>|
| Un-vaccinated<br>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<br>* Self sample using The Rover's Evalyn Brush<br>Procedure: Self sample from the oral cavity<br>* Self sample using COPAN FloqSwab<br>Other: Questionnaire<br>* Questionnaire about vaccination status and sexual behaviour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal and oral HPV-6, HPV-11, HPV-16 and HPV-18 prevalence | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Description of oral and vaginal overall genotype distribution among vaccinated and non-vaccination participants |  | Within 2 months after self-collection of specimens | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV vaccines, HPV-6, HPV-11, HPV-16, HPV-18, Gardasil