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ESCUDDO Long Term Follow Up

Not Yet RecruitingN/A

Sponsor: National Cancer Institute (NCI)

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

Interventions: Non-Interventional Study

Countries: Costa Rica

This study evaluates the long term protection provided by either one or two doses of the 9vHPV vaccine for participants who were part of the ESCUDDO study.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* \* Participation in ESCUDDO base study

  * Randomization (excluding the two participants who had major protocol deviations in the ESCUDDO base study) to the Gardasil9 1- and 2-dose arms
  * A signed informed consent form for ESCUDDO LTFU.
  * 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:

* \* Enrollment cannot occur beyond her 10 year study visit

  * LTFU Survey group:

    * They report they are pregnant;
    * They report being vaccinated against HPV;
    * The qualified healthcare personnel determining eligibility, in agreement with principal investigator, considers a reason that precludes participation; or
    * They do not have an identification document

Locations (1)

Liberia, Guanacaste Province, Costa Rica