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ESCUDDO Long Term Follow Up

Enrolling By InvitationPhase 4

Sponsor: National Cancer Institute (NCI)

Conditions: Human Papillomavirus Infection, Human Papillomavirus-Related Malignant Neoplasm

Interventions: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed, Recombinant Human Papillomavirus Nonavalent Vaccine

Countries: Costa Rica

This phase IV trial evaluates the long term protection provided by either one or two doses of the 9v human papillomavirus (HPV) vaccine for participants who were part of the ESCUDDO study.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* TRIAL PARTICIPANTS: Participation in ESCUDDO base study
* TRIAL PARTICIPANTS: Randomization (excluding the two participants who had major protocol deviations in the ESCUDDO base study) to the Gardasil9 1- and 2-dose arms
* TRIAL PARTICIPANTS: A signed informed consent form for ESCUDDO LTFU
* TRIAL PARTICIPANTS: Opportunity to complete three total study visits
* LTFU SURVEY GROUP: We will match the current ages of ESCUDDO LTFU trial participants when they attend their 9.5-year study visit (21 to 26 years of age)

Exclusion Criteria:

* TRIAL PARTICIPANTS: Enrollment cannot occur beyond her 10 year study visit
* LTFU SURVEY GROUP: They report they are pregnant
* LTFU SURVEY GROUP: They report being vaccinated against HPV
* LTFU SURVEY GROUP: The qualified healthcare personnel determining eligibility, in agreement with principal investigator, considers a reason that precludes participation; or
* LTFU SURVEY GROUP: They do not have an identification document

Locations (1)

Liberia, Guanacaste Province, Costa Rica