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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 is a Phase 1 study that has completed, run by DynPort Vaccine Company LLC, A GDIT Company. The registered enrollment target is 350 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00042094
The ClinicalTrials.gov registry entry for NCT00042094 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DynPort Vaccine Company LLC, A GDIT Company, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cell-Cultured Smallpox Vaccine compared to Dryvax® is the first listed.
NCT00042094 reports 0 study locations.
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.
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