Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04688476 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

An Extended Follow-Up Study of the HPV Vaccine Delayed Booster Trial

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 1 → 6 primary endpoints
See other at-risk trials from University of Arizona

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 4 more changesShow less
    • Results posted: Oct 9, 2026
    • Study completion pushed from Dec 2025 to Dec 2026
    • Secondary endpoint revised
    • Eligibility criteria expanded, about 3 words
  2. Primary completion date changed from estimate of May 2025 to Sep 9, 2025
    • Study completion date: May 2025 to Dec 2025
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Start date: Nov 6, 2020 to Nov 17, 2020v4
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 120 to confirmed 113
    • Site details revised at 2 of 2 sites
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04688476
Lead Sponsor University of Arizona
Collaborators: National Cancer Institute (NCI), University of California, Los Angeles
Conditions
(from sponsor)		 HPV-associated Cancer
Enrollment 113 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov