Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative Treatment for Cervical Intra-epithelial Neoplasia

Korábbi kezelés

• Use of other investigational/non-registered product within 30 days preceding the 1st vaccine dose
• Previous vaccination against HPV

Más betegség

• Cancer or autoimmune disease under treatment. Patients who have a history of cancer or autoimmune disease but are not currently being treated for the condition will be included
• 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)

Egyéb

• Patients who meet any of the following exclusion criteria will not be eligible for this study:
• Continuous administration of immunosuppressants
• 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)

• Patients who meet all of the following inclusion criteria will be considered eligible for this study:
• 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 obtained from the subject prior to enrolment
• Free of other relevant health problems as established by medical history and clinical examination, e.g. immunosuppression
• 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)