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

Imperial College London0 个研究点目标入组 1,000 人开始时间: 2019年7月15日最近更新: 2019年12月16日

试验速览

暂无简介。

•- Female (18-55y) attending for local treatment for presumed CIN2 (cytological and colposcopy impression) OR presumed CIN3 (cytological and colposcopy impression) OR presumed cGIN/AIS (cytological and colposcopy impression) OR biopsy-confirmed CIN2 OR biopsy-confirmed CIN3 OR biopsy-confirmed CGIN/AIS
•- Written informed consent
•- Free of other relevant health problems as established by medical history and clinical examination
•- Patients who the investigator believes can and will comply with the protocol requirements (e.g. attendance at clinic appointments and return for follow-up visits)
•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

•- Use of other investigational/ non-registered product within 30 days prior to the 1st vaccine dose
•- Continuous administration of immunosuppressants
•- 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 (will be postponed)
•- Pregnant women or women intending to get pregnant during the next 6 months (if pregnant during follow-up, remaining doses will be delayed until after delivery)

发起方