ESCUDDO
A Scientific Evaluation of One or Two Doses of Vaccine Against Human Papillomavirus: the ESCUDDO Study
N = 20,330NCT03180034
- Population
- Girls aged 12 to 16 years; 20,330 enrolled and randomised, plus 3005 unvaccinated participants in the nonrandomised survey.
- Design
- Randomised 1:1:1:1 trial of one or two doses of a bivalent HPV vaccine or one or two doses of a nonavalent HPV vaccine, designed to test noninferiority of one dose to two doses. The primary end point was new HPV type 16 or 18 infection occurring from month 12 to month 60 and persisting for at least 6 months, with a prespecified noninferiority margin of 1.25 infections per 100 participants. Vaccine effectiveness was also assessed by comparing HPV16 or HPV18 infection among trial participants with that among girls and women in a nonrandomized survey. ClinicalTrials.gov lists an enrolment of 27,945 and a phase 4 classification.
- Primary endpoint
- Persistent HPV infection
- Arms
- One dose of bivalent vaccine (experimental): One dose of bivalent HPV vaccine
- Two doses of bivalent vaccine (control): Two doses of bivalent HPV vaccine
- One dose of nonavalent vaccine (experimental): One dose of nonavalent HPV vaccine
- Two doses of nonavalent vaccine (control): Two doses of nonavalent HPV vaccine
- People
- Kreimer AR, senior author Herrero R