NCT00867464Active, not recruiting
Extended Follow Up of Young Women in Costa Rica Who Received Vaccine for Human Papillomavirus Types 16 and 18 and Unvaccinated Controls
Extended Follow-Up of Young Women in Costa Rica Who Received Vaccination Against Human Papillomavirus Types 16 and 18 and Unvaccinated Controls
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
This research trial studies extended follow up of young women in Costa Rica who received vaccine for human papillomavirus types 16 and 18 and unvaccinated controls. Collecting information from young women in Costa Rica who have received vaccine for human papillomavirus types 16 and 18 and a new group of unvaccinated controls enrolled for the follow-up period, may help doctors learn more about the risks and benefits of prophylactic human papillomavirus vaccine.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 8670 (estimated)
- First submitted
- 20 Mar 2009
- Start date
- 30 Mar 2009
- Primary completion date
- 23 Dec 2026
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Cervical cancer, Childhood cancers
- NCT number
- NCT00867464
What you commit to
- Study type: Observational
- Planned participants: 8670
- From 30 Mar 2009 to the primary completion date, 23 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Vaccination with Gardasil or Cervarix will be an exclusionary criterion, but few women are expected to have received these vaccines at the time of enrollment; use of these vaccines after enrollment is not a criterion for study interruption but we plan to collect information on vaccination history so that the few women who report having been vaccinated with one of the HPV vaccines after enrollment can be evaluated separately at analysis
Other illness
- History of cervical cancer
- History of hysterectomy
- Any important medical condition or other criteria that the investigator considers that precludes enrollment
Who the study is looking for
- Women who participated in the Costa Rica Vaccine Trial (CVT) and lived in the Guanacaste province and a few areas of Puntarenas closest to Guanacaste will be eligible for the long-term follow up LTFU study
- Women who received the HPV-16/18 vaccine at the start of CVT will be invited for up to 6 years of additional follow-up, and women who were originally in the control arm of CVT and were offered the HPV-16/18 vaccine at crossover will be invited for an additional 2 years of follow-up
- A subset of the control arm women who are in the crossover immunogenicity subcohort will be followed the full 6 years
- Some women who received HPV vaccination and were not invited into the LTFU protocol (stopped attending their screening visits during CVT, discontinued their study participation during CVT or lived outside the study area) will be invited to participate in the LTFU protocol, particularly those who received an incomplete vaccination schedule
- UNVACCINATED CONTROL GROUP:
- Born in or between July 1978 and November 1987
- Residents of Guanacaste Province and a few areas of Puntarenas closest to Guanacaste at some point during 2005
- Able to speak/understand Spanish
- Apparently mentally competent
- Written informed consent obtained prior to enrollment
Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Agencia Costarricense de Investigaciones Biomédicas (ACIB) Coordinator of this site? Confirm its status | Liberia | Costa Rica | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.