VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
NCT01374984 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2026-05-12
Summary
This is a post-marketing study to verify the clinical benefits of VIGIV \[CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution\] in the resolution of complications resulting from smallpox vaccination in eligible patients treated with VIGIV.
Conditions
- Complication of Smallpox Vaccination
Interventions
- BIOLOGICAL
-
VIGIV
VIGIV is licensed in US, by the FDA, for the treatment of complications of smallpox vaccinations and is available to eligible patients regardless of participation in this study.
Sponsors & Collaborators
-
Centers for Disease Control and Prevention
collaborator FED -
Emergent BioSolutions
lead INDUSTRY
Principal Investigators
-
David Cassie, MSc · Emergent BioSolutions
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-08-31
- Primary Completion
- 2027-08-31
- Completion
- 2028-08-31
- FDA Drug
- Yes
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