Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa R… (NCT05237947) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial
Costa Rica5,000 participantsStarted 2022-03-01
Plain-language 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.
Who can participate
Age range18 Years – 30 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* INCLUSION CRITERIA AT ENROLLMENT: Female.
* INCLUSION CRITERIA AT ENROLLMENT: Aged between 18 and 30 years inclusive.
* INCLUSION CRITERIA AT ENROLLMENT: Living in the study area.
* INCLUSION CRITERIA AT ENROLLMENT: Able to communicate with study personnel.
* INCLUSION CRITERIA AT ENROLLMENT: Willing to participate in the study and sign the informed consent.
* INCLUSION CRITERIA AT ENROLLMENT: In good health as determined by a medical history (physical exam will be conducted if necessary per the doctor's criterion.
* DEFERRAL CRITERIA AT ENROLLMENT VISIT: The enrollment visit will be deferred (i.e., rescheduled for another date) for participants if: the self-collected cervical sample is not able to be collected.
* DEFERRAL CRITERIA AT THE VACCINATION VISIT: The vaccination visit will be deferred (i.e., rescheduled for another date) for participants if:
* They have an acute disease that precludes vaccination (though vaccines can be administered to potential participants with a minor illness such as diarrhea and mild upper respiratory infection)
* They are receiving immunosuppressive treatment, e.g. corticosteroids
* They have received any registered vaccine in the last 15 days.
Exclusion Criteria:
* EXCLUSION CRITERIA AT ENROLLMENT VISIT: They have been vaccinated against human papillomavirus (HPV).
* EXCLUSION CRITERIA AT ENROLLMENT VISIT: They are allergic to yeast or another vaccine components.
* EXCLUSION CRITERIA AT ENROLLMENT VISIT: They h…
What they're measuring
1
Incidence of persistent human papillomavirus (HPV) infection
Timeframe: 6-month persistence observed during follow-up