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NCT00050518 · ClinicalTrials.gov registry record · Phase 2
APSV in Vaccinia Naive Adults
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 444
- Enrollment target
NCT00050518 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 444 participants.
The verdict
NCT00050518, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 444 participants
- Enrollment target
Study Summary
The study seeks to define, with precision, the safety and efficacy of APSV, two dose potencies of one lot in vaccinia-naive adults. The ability of this vaccine to induce a classic �take� as defined by formation of a lesion at the injection site consistent with the �Jennerian� process (see Appendix A) and vaccine specific immune responses will be assessed. The local cutaneous lesion is considered to be a surrogate for clinical effectiveness of live, replicating smallpox vaccines. Neutralizing antibody formation has been correlated with takes for the Dryvax vaccine and is considered to be cross-protective for other orthopoxviruses, including variola. The study also seeks to characterize preliminarily the cell mediated immune (CMI) response to APSV (as compared to Dryvax).
Interventions
- BIOLOGICAL Aventis Pasteur Smallpox Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Est. Completion | 2003-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00050518
The ClinicalTrials.gov registry entry for NCT00050518 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 444 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aventis Pasteur Smallpox Vaccine is the first listed.
NCT00050518 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00050518 about?
NCT00050518 is a clinical study titled "APSV in Vaccinia Naive Adults". The study seeks to define, with precision, the safety and efficacy of APSV, two dose potencies of one lot in vaccinia-naive adults. The ability of this vaccine to induce a classic �take� as defined by formation of a lesion at the injection site consistent with the �Jennerian� process (see Appendix A...
What is the current status of trial NCT00050518?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 444 participants. Estimated completion is 2003-02.
What interventions are being tested in trial NCT00050518?
The interventions under investigation include: Aventis Pasteur Smallpox Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00050518?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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