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OpenTrials
Completed

NCT Number: NCT02934724

Impact of HPV Vaccine On The Prevalence Of HPV In Norway

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.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Cancer Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Precancerous Conditions Stomatognathic Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–20 year

Sex eligibility

Female

Study type

Observational

Primary location

Oslo University Hospital, Cancer Registry of Norway

Oslo, 0379, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self sample from vagina

Procedure

Self sample using The Rover's Evalyn Brush

Self sample from the oral cavity

Procedure

Self sample using COPAN FloqSwab

Questionnaire

Other

Questionnaire about vaccination status and sexual behaviour

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University Hospital, Akershus

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2016
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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