ESCUDDO Long Term Follow Up

PRIMARY OBJECTIVES:

I. To estimate the IRD and RR of incident HPV 6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection between recipients of single dose and 2 doses of 9vHPV vaccine, 7 to 10 years following HPV vaccination.

II. To estimate the IRD and RR of incident HPV 6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection between recipients of single dose and 2 doses of 9vHPV vaccine, 1 to 10 years following HPV vaccination.

OUTLINE: This is an observational study. Participants are assigned to 1 of 3 groups.

GROUP I (ONE DOSE GARDASIL9): Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.

GROUP II (TWO DOSE GARDASIL9): Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.

GROUP III (UNVACCINATED): Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.

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