OVEL: Nonavalent HPV vaccine after local conservative treatment for cervical pre-invasive disease - a randomised controlled trial - NOVE

Imperial College London0 sites1,000 target enrollmentStarted: July 10, 2019Last updated: December 10, 2019

Conditions

Drugs

Trial Snapshot

No summary available.

•- Female 18-55 years old, attending hospital for localised cervical treatment for biopsy confirmed cervical intra-epithelial neoplasia (CIN) 2/3
•- Written informed consent
•- Free of other relevant health problems as established by medical history and clinical examination
•- Able to comply with protocol including completion of diary cards, follow up etc
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1000
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- Women treated for cervical glandular intra-epithelial neoplasia (cGIN) / adenocarcinoma in situ (AIS)
•- Use of other investigational/ non-registered product within 30 days prior to the 1st vaccine dose
•- Continuous administration of immunosuppressants prior to the 1st vaccine dose
•- Previous vaccination against HPV with Gardasil™ or Cervarix™
•- Cancer or autoimmune disease under treatment
•- Any confirmed or suspected immunosuppressive condition, including HIV infection
•- History of allergic disease or any neurologic disorders likely to interact with study vaccination
•- Acute febrile disease at enrolment (oral > 37.5°C / axillary temperature > 37.5°C) (will be postponed)
•- Pregnant women or women intending to get pregnant in the next year (if pregnant during follow-up, remaining doses will be delayed until after delivery)

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