Impact of HPV Vaccine On The Prevalence Of HPV In Norway

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02934724
• Other study ID #: 2014/2333
• Status: Completed
• Start date: November 2016
• Est. completion date: February 2017

Study information

• Verified date: December 2020
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Procedure:
• Self sample from vagina
Self sample using The Rover's Evalyn Brush
• Self sample from the oral cavity
Self sample using COPAN FloqSwab

Other:
• Questionnaire
Questionnaire about vaccination status and sexual behaviour

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Cancer Registry of Norway	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Enerly E, Flingtorp R, Christiansen IK, Campbell S, Hansen M, Myklebust TÅ, Weiderpass E, Nygård M. An observational study comparing HPV prevalence and type distribution between HPV-vaccinated and -unvaccinated girls after introduction of school-based HPV — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Description of oral and vaginal overall genotype distribution among vaccinated and non-vaccination participants		Within 2 months after self-collection of specimens