Trials / Active Not Recruiting
Active Not RecruitingNCT00867464
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
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 8,670 (estimated)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the 10-year global impact of human papillomavirus (HPV)-16/18 vaccination of young adult women. II. To evaluate determinants of the immune response to HPV and the vaccine, and markers of long-term protection. III. To evaluate the natural history of HPV and cervical disease in vaccinated and unvaccinated populations. OUTLINE: Participants undergo long term follow-up comprising risk factor questionnaire, pelvic examination for all sexually experienced women, and specimen collection at years 6, 8, and 10.
Conditions
- Anal Carcinoma
- Cervical Carcinoma
- Human Papillomavirus Infection
- Human Papillomavirus-Related Cervical Carcinoma
- Oral Cavity Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Cytology Specimen Collection Procedure | Correlative studies |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| OTHER | Long-term Follow-up | Undergo extended follow-up |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2009-03-30
- Primary completion
- 2026-04-30
- Completion
- 2026-04-30
- First posted
- 2009-03-23
- Last updated
- 2026-03-03
Locations
1 site across 1 country: Costa Rica
Source: ClinicalTrials.gov record NCT00867464. Inclusion in this directory is not an endorsement.