ESCUDDO Long Term Follow Up
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNational Cancer Institute (NCI)
About this trial
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 criteria
Qualifiers
* 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
Disqualifiers
* Enrollment cannot occur beyond her 10 year study visit
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
Trial design
Treatments tested in this trial
- Non-Interventional Study
Treatment groups
9,700 Participants
are divided into 3 treatment groupsSponsors and collaborators
National Cancer Institute (NCI)
Lead sponsor
Merck Sharp and Dohme LLC
Collaborator
Source ClinicalTrials.gov