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NCT01184079 · ClinicalTrials.gov registry record · NA
Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
A NA study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 220
- Enrollment target
NCT01184079 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 220 participants.
The verdict
NCT01184079, a NA study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 220 participants
- Enrollment target
Study Summary
The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months. Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the usual timing control group (C): H0: δ ≤ -δ0 versus H1: δ \> -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin
Interventions
- BIOLOGICAL quadrivalent human papillomavirus vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01184079
The ClinicalTrials.gov registry entry for NCT01184079 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which quadrivalent human papillomavirus vaccine is the first listed.
NCT01184079 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01184079 about?
NCT01184079 is a clinical study titled "Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting". The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to sched...
What is the current status of trial NCT01184079?
This trial is currently completed. It is a NA study. The enrollment target is 220 participants. The study started on 2010-10. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01184079?
The interventions under investigation include: quadrivalent human papillomavirus vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01184079?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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