NCT00053495Phase 2Completed

Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2003-06Actual

Enrollment · participants353Actual

Source updated2024-03-18Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied: Smallpox
Treatments or interventions studied: type: BIOLOGICAL; name: Vaccinia virus: ACAM2000 smallpox vaccine; type: BIOLOGICAL; name: vaccinia virus (calf lymph): Dryvax; otherNames: Dryvax®
Primary outcomes · main study measures: Read the study measures
measure: Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine; description: 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.; timeFrame: Days 0 to 30 post-vaccination; measure: Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.; timeFrame: Day 30 post-vaccination; measure: Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.; timeFrame: Day 30 post-vaccination
History coverage: Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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