- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04688476
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 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724
- University of Arizona
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California
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Los Angeles, California, United States, 90095
- University of California, Los Angeles
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Study participants who received one booster dose of Gardasil 9 at month 24 and elected not to receive the second booster at month 30 in the original "HPV vaccine delayed booster trial"
- 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:
- Has received any HPV vaccine dose from an external source at any point during or after participation in the HPV vaccine delayed booster trial.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The differences in geometric mean titer (GMT) of HPV 16 and HPV18 between 30 vs. 48, 48 vs. 60, and 60 vs. 72 months after the priming dose of Gardasil
Time Frame: 72 months
|
72 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The differences in geometric mean titer of other HPV types (HPV6/11/31/33/45/52/58) between 30 vs. 48, 48 vs. 60, and 60 vs. 72 months after the priming dose of Gardasil 9
Time Frame: 72 months
|
72 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2007882387
- UG1 242596 (Other Grant/Funding Number: DCP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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