Clinical trial NCT02934724: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Intraepithelial Neoplasia
Cervical Cancer
Oropharyngeal Cancer
Keywords: HPV vaccines
HPV-6
HPV-11
HPV-16
HPV-18
Gardasil
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
First posted: 2016-10-17
Enrollment: 315
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women resident to Norway in 2009

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.

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

Primary outcomes:
measure: Vaginal and oral HPV-6, HPV-11, HPV-16 and HPV-18 prevalence
timeFrame: Within 2 months after self-collection of specimens
Secondary outcomes:
measure: Description of oral and vaginal overall genotype distribution among vaccinated and non-vaccination participants
timeFrame: Within 2 months after self-collection of specimens
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Cancer Registry of Norway
Study officials:
affiliation: Oslo University Hospital
name: Espen Enerly, Dr Scient
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Giske Ursin, Dr.Med
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.