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NCT01259453 · ClinicalTrials.gov registry record · Phase 4
Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules
A Phase 4 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 4
- Development phase
- 595
- Enrollment target
NCT01259453: Completed Phase 4 study, sponsored by Yale University.
NCT01259453 is a Phase 4 study that has completed, run by Yale University. The registered enrollment target is 595 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01259453, a Phase 4 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 595 participants
- Enrollment target
Study Summary
The investigators seek to provide immunization for individuals who are at high risk of contracting hepatitis B virus (HBV) infection because of their illicit drug use. The investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport, CT and Chicago, IL to contact high risk individuals and refer them for vaccination. The primary purpose of the study is to compare the standard schedule of hepatitis B vaccination at 0, 1, and 6 months to an accelerated schedule of vaccination at 0, 1, and 2 months. The investigators hypothesize that the accelerated scheduling will result in improved completion rates without significant loss in vaccine efficacy.
Interventions
- BIOLOGICAL Vaccination to prevent hepatitis B virus infection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 595 participants |
| Start Date | 2003-05 |
| Est. Completion | 2006-08 |
| Phase | Phase 4 |
What the finished NCT01259453 record still lists
NCT01259453 is an interventional study that assigns participants to a tested intervention. The registered 595 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 1 intervention - of which Vaccination to prevent hepatitis B virus infection is the first listed.
NCT01259453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01259453 about?
NCT01259453 is a clinical study titled "Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules". The investigators seek to provide immunization for individuals who are at high risk of contracting hepatitis B virus (HBV) infection because of their illicit drug use. The investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport, CT and Chicago, IL to contact high ...
What is the current status of trial NCT01259453?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 595 participants. The study started on 2003-05. Estimated completion is 2006-08.
What interventions are being tested in trial NCT01259453?
The interventions under investigation include: Vaccination to prevent hepatitis B virus infection (BIOLOGICAL).
Who is sponsoring clinical trial NCT01259453?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01259453's enrollment target sits among peer trials
595 147th of 2000 higher than 1,854 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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