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NCT00106964 · ClinicalTrials.gov registry record · Phase 4
Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 371
- Enrollment target
NCT00106964: Completed Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT00106964 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 371 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00106964, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 371 participants
- Enrollment target
Study Summary
Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate protection against this virus. In an attempt to improve response to vaccination and achieve protection from hepatitis B, this trial will compare the immune system response to 3 hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age.
Primary Outcome
The primary outcome, percentage positive sero-response, was compared between Arm 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) and measured 4 weeks after the third vaccination at Week 28. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL.
Interventions
- BIOLOGICAL Engerix-B 20 mcg
- BIOLOGICAL Engerix-B 40 mcg
- BIOLOGICAL Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 371 participants |
| Start Date | 2004-01 |
| Est. Completion | 2009-06 |
| Phase | Phase 4 |
What the finished NCT00106964 record still lists
NCT00106964 is an interventional study that assigns participants to a tested intervention. The registered 371 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 3 interventions - of which Engerix-B 20 mcg is the first listed.
NCT00106964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00106964 about?
NCT00106964 is a clinical study titled "Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth". Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate protection against this virus. In an attempt to improve response to vaccination and achieve protection from hepatit...
What is the current status of trial NCT00106964?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 371 participants. The study started on 2004-01. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00106964?
The interventions under investigation include: Engerix-B 20 mcg (BIOLOGICAL), Engerix-B 40 mcg (BIOLOGICAL), Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg (BIOLOGICAL).
Who is sponsoring clinical trial NCT00106964?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00106964's enrollment target sits among peer trials
371 223rd of 2000 higher than 1,778 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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