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NCT00053495 · ClinicalTrials.gov registry record · Phase 2
Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
A Phase 2 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 2
- Development phase
- 353
- Enrollment target
NCT00053495: Completed Phase 2 study, sponsored by Emergent BioSolutions.
NCT00053495 is a Phase 2 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 353 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (165% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00053495, a Phase 2 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 353 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
Primary Outcome
The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity.
Interventions
- BIOLOGICAL Vaccinia virus: ACAM2000 smallpox vaccine
- BIOLOGICAL vaccinia virus (calf lymph): Dryvax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2003-01 |
| Est. Completion | 2003-11 |
| Phase | Phase 2 |
What the finished NCT00053495 record still lists
NCT00053495 is an interventional study that assigns participants to a tested intervention. The registered 353 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (165% higher).
The record links to 0 conditions, and to 2 interventions - of which Vaccinia virus: ACAM2000 smallpox vaccine is the first listed.
NCT00053495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00053495 about?
NCT00053495 is a clinical study titled "Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination". The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
What is the current status of trial NCT00053495?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 353 participants. The study started on 2003-01. Estimated completion is 2003-11.
What interventions are being tested in trial NCT00053495?
The interventions under investigation include: Vaccinia virus: ACAM2000 smallpox vaccine (BIOLOGICAL), vaccinia virus (calf lymph): Dryvax (BIOLOGICAL).
Who is sponsoring clinical trial NCT00053495?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00053495's enrollment target sits among peer trials
353 129th of 2000 higher than 1,871 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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