drugset / Trial / NCT05237947

Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial

NCT05237947

Phase 4 Active not recruiting 5000 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupDouble-blindPrevention

Summary

This phase IV trial tests whether a single dose of the human papillomavirus (HPV) vaccine works in preventing cervical cancer in young women in Costa Rica. Human papilloma viruses, called HPV, are a group of viruses that very frequently cause infection in both men and women, mainly in the genital organs. There are many types of HPV, and some can cause cancer. The World Health Organization recommends a two-dose schedule for adolescents 9-14 and three doses for individuals 15 years old or older. This study examines whether a single dose of HPV vaccine can reduce the frequency with which women between ages 18-30 become infected with HPV.

Timeline

Start
2022-03-01
Primary completion
2026-08-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cervarix Vaccine Intramuscular
Comparator Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed Vaccine Intramuscular
Subject Gardasil 9 Vaccine Intramuscular

Indications