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NCT00107042 · ClinicalTrials.gov registry record · Phase 2
Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
NCT00107042 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 123 participants.
The verdict
NCT00107042, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
Study Summary
This study will evaluate 2 licensed vaccine products (Recombivax and Twinrix) given in a two-dose schedule to youth at risk for hepatitis B and HIV infection to evaluate immunogenicity of the products in this population, barriers to vaccine delivery, and factors which predict a diminished immune response. Since these youths are also potential candidates for future HIV vaccine trials, this study will also include preliminary assessment of youths' understanding of informed consent forms, and willingness to participate in a vaccine trial and return for multiple visits (including blood draws for immunologic assessment).
Interventions
- BIOLOGICAL Twinrix
- BIOLOGICAL Recombivax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2004-02 |
| Est. Completion | 2008-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00107042
The ClinicalTrials.gov registry entry for NCT00107042 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Twinrix is the first listed.
NCT00107042 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00107042 about?
NCT00107042 is a clinical study titled "Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths". This study will evaluate 2 licensed vaccine products (Recombivax and Twinrix) given in a two-dose schedule to youth at risk for hepatitis B and HIV infection to evaluate immunogenicity of the products in this population, barriers to vaccine delivery, and factors which predict a diminished immune res...
What is the current status of trial NCT00107042?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2004-02. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00107042?
The interventions under investigation include: Twinrix (BIOLOGICAL), Recombivax (BIOLOGICAL).
Who is sponsoring clinical trial NCT00107042?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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