Vaccine Effectiveness of One Dose of the Nonavalent Human Papillomavirus (HPV) Vaccine Among Youn… (NCT07314307) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Vaccine Effectiveness of One Dose of the Nonavalent Human Papillomavirus (HPV) Vaccine Among Young-adult Women in Sweden Among Women Participating in a Clinical Trial of Concomitant HPV Vaccination and Screening
Sweden150,000 participantsStarted 2021-05-03
Plain-language summary
This study aims to evaluate the vaccine effectiveness of 1 dose the nonavalent human papillomavirus (HPV) vaccine against HPV16, 18, 31, 33, 45, 52, and 58 infection among young adult women in Sweden participating in a nationwide HPV elimination trial.
Who can participate
Age range22 Years – 31 Years
SexFEMALE
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Inclusion Criteria:
* Eligible women will include resident women born between 1994-1999 (1993-1999 in the non intervention arm), who have not opted out of the screening program and who consent to participate in the study.
Exclusion Criteria:
* Known history of severe allergic reaction or hypersensitivity to any of the components of the HPV vaccine.For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80 or Sodium borate
* Known history of immune-related disorders
* Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever.
* Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose
* Current pregnancy (reported)
* Women with a total hysterectomy