500
Participants
Start Date
December 1, 2023
Primary Completion Date
December 1, 2028
Study Completion Date
December 1, 2030
Gardasil 9 Suspension for Injection
"After randomisation in the Gardasil arm, women will receive 3 Gardasil vaccinations~1. First injection: preferable at time of start treatment (imiquimod, lase or surgery). Window 4 weeks prior to treatment start (because surgical treatment can be postponed for logistical reasons) and 4 weeks after start treatment.~2. Second injection: should be administered at least 1 month after the first injection and 3 months before the third injection.~3. Third injection should be administered at 3 months after second injection. All injections should be administered within 1 year."
Placebo
"After randomisation in the PLacebo arm, women will receive 3 Placebo vaccination with NaCl 0.9%~1. First injection: preferable at time of start treatment (imiquimod, lase or surgery). Window 4 weeks prior to treatment start (because surgical treatment can be postponed for logistical reasons) and 4 weeks after start treatment.~2. Second injection: should be administered at least 1 month after the first injection and 3 months before the third injection.~3. Third injection should be administered at 3 months after second injection. All injections should be administered within 1 year."
Erasmus MC, Rotterdam
Lead Sponsor
Dutch Cancer Society
OTHER
Erasmus Medical Center
OTHER