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NCT00042094 · ClinicalTrials.gov registry record · Phase 1
Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax®
A Phase 1 study, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 350
- Enrollment target
NCT00042094: Completed Phase 1 study, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
NCT00042094 is a Phase 1 study that has completed, run by DynPort Vaccine Company LLC, A GDIT Company. The registered enrollment target is 350 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (483% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00042094, a Phase 1 study, has completed, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 350 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured vaccine (CCSV) in a comparative fashion. Across 3 cohorts, 150 vaccinia-naive volunteers will be randomly assigned to receive either CCSV (100 volunteers) or Dryvax® (50 volunteers) in a blinded fashion. Subjects will be followed closely for up to 6 months and a subgroup of volunteers will be followed up to 3 years in order to evaluate the duration of immunity following vaccination. Another cohort will enroll 100 vaccinia-experienced volunteers and randomly assign them to receive either CCSV (50 volunteers) or Dryvax® (50 volunteers) and a sub group will be followed up to 3 years. A fifth cohort will enroll 100 vaccinia-naive volunteers and randomly assign them to receive different dilutions of CCSV (1:1, 1:5, 1:25, and 1:50).
Interventions
- BIOLOGICAL Cell-Cultured Smallpox Vaccine compared to Dryvax®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2002-03 |
| Est. Completion | 2003-03 |
| Phase | Phase 1 |
What the finished NCT00042094 record still lists
NCT00042094 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (483% higher).
The record links to 0 conditions, and to 1 intervention - of which Cell-Cultured Smallpox Vaccine compared to Dryvax® is the first listed.
NCT00042094 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00042094 about?
NCT00042094 is a clinical study titled "Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax®". This study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured vaccine (CCSV) in a comparative fashion. Across 3 cohorts, 150 vaccinia-naive volunteers will be randomly assigned to receive either CCSV (100 volunteers) or Dryvax® (50 volunteers) in a blinded fashion. Subje...
What is the current status of trial NCT00042094?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 350 participants. The study started on 2002-03. Estimated completion is 2003-03.
What interventions are being tested in trial NCT00042094?
The interventions under investigation include: Cell-Cultured Smallpox Vaccine compared to Dryvax® (BIOLOGICAL).
Who is sponsoring clinical trial NCT00042094?
This trial is sponsored by DynPort Vaccine Company LLC, A GDIT Company, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00042094's enrollment target sits among peer trials
350 97th of 2000 higher than 1,902 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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