An Extended Follow-Up Study of the HPV Vaccine Delayed Booster Trial
NCT ID: NCT04688476
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
113 participants
OBSERVATIONAL
2020-11-17
2025-12-31
Brief Summary
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For this follow-up study, we anticipate that we will be able to accrue 120 participants from the original study who received just one booster dose. Participants who received one booster dose of Gardasil 9 will be contacted to return to the clinic to provide blood specimens at 48 (±3), 60 (±3), and 72 (±3) months after the priming dose. Serologic geometric mean titers (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58) will be measured at each time point.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Ability to understand and the willingness to sign a written informed consent document by the legal representative(s) of the participant.
* Ability to understand and the willingness to sign a written assent document by the participant.
Exclusion Criteria
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, Los Angeles
OTHER
University of Arizona
OTHER
Responsible Party
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Sherry Chow
Principal Investigator
Locations
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University of Arizona
Tucson, Arizona, United States
University of California, Los Angeles
Los Angeles, California, United States
Countries
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Other Identifiers
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UG1 242596
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2007882387
Identifier Type: -
Identifier Source: org_study_id
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