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NCT04688476 · ClinicalTrials.gov registry record
An Extended Follow-Up Study of the HPV Vaccine Delayed Booster Trial
A clinical trial of HPV Associated Cancer, sponsored by University of Arizona.
- Active
- Registry status
- 113
- Enrollment target
- 2
- Study locations
NCT04688476: Active study of HPV Associated Cancer, sponsored by University of Arizona.
NCT04688476 is a study of HPV Associated Cancer that is active but no longer recruiting, run by University of Arizona. The registered enrollment target is 113 participants. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04688476, a study of HPV Associated Cancer, is active but no longer recruiting, sponsored by University of Arizona.
- ACTIVE NOT RECRUITING
- Registry status
- 113 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is an extended follow-up study to follow-up study participants who received 1 booster dose of Gardasil 9 in the "HPV vaccine delayed booster trial." This was a prospective, single-arm, open-label, non-randomized, phase IIa trial among 9-11 year-old girls and boys to determine the immunogenicity after a single dose of the nonavalent HPV vaccine (Gardasil 9) over 24 months, with a delayed booster dose at 24 months and an optional booster at 30 months after the first dose. Participants provided blood specimens at 6, 12, 18, 24, and 30 months after the first dose. Serologic geometric mean titers (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58) were measured at each time point. One hundred and thirty-three (133) participants received one booster dose at month 24 and elected not to receive the second booster at month 30. 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.
Conditions Studied
Study Locations (2)
Arizona
- University of Arizona - Tucson
California
- University of California, Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2020-11-17 |
| Est. Completion | 2025-12 |
What the registry record for NCT04688476 still lists
NCT04688476 is an observational study that tracks outcomes without assigning an intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with HPV Associated Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT04688476 reports a single indexed study location in Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04688476 about?
NCT04688476 is a clinical study titled "An Extended Follow-Up Study of the HPV Vaccine Delayed Booster Trial". This is an extended follow-up study to follow-up study participants who received 1 booster dose of Gardasil 9 in the "HPV vaccine delayed booster trial." This was a prospective, single-arm, open-label, non-randomized, phase IIa trial among 9-11 year-old girls and boys to determine the immunogenicity...
What is the current status of trial NCT04688476?
This trial is currently active not recruiting. The enrollment target is 113 participants. The study started on 2020-11-17. Estimated completion is 2025-12.
What conditions does trial NCT04688476 study?
This clinical trial studies the following conditions: HPV Associated Cancer.
Who is sponsoring clinical trial NCT04688476?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04688476 being conducted?
This trial has 2 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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