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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: Completed NA study, sponsored by University of Pittsburgh.
NCT01184079 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 220 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Geometric mean titer (GMT) and 95% confidence intervals around titer 1 month after dose 3 in per protocol population, comparing the two groups.
Interventions
- BIOLOGICAL quadrivalent human papillomavirus vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-05 |
| Phase | NA |
What the finished NCT01184079 record still lists
NCT01184079 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which quadrivalent human papillomavirus vaccine is the first listed.
NCT01184079 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01184079's enrollment target sits among peer trials
220 481st of 2000 higher than 1,516 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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