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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 is a Phase 4 study that has completed, run by Yale University. The registered enrollment target is 595 participants.

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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

FieldValue
Enrollment Target 595 participants
Start Date 2003-05
Est. Completion 2006-08
Phase Phase 4

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT01259453

The ClinicalTrials.gov registry entry for NCT01259453 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 595 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Vaccination to prevent hepatitis B virus infection is the first listed.

NCT01259453 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.