VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
Enrolling by invitation
Conditions studied: Complication of Smallpox Vaccination
In brief
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.
Key facts
- Study ID
- NCT01374984
- Run by
- Emergent BioSolutions
- People needed
- 100
- Starts
- 2007-08-01
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-05-12
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects treated with VIGIV deployed from the US Strategic National Stockpile for any of the following conditions:
- Eczema vaccinatum.
- Progressive vaccinia.
- Severe generalized vaccinia.
- Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy, or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions.
- Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard.
- Informed consent voluntarily signed by subject, legal guardian or representative to participate in the study. For minors, the informed consent form must be signed by a legally acceptable representative and when appropriate, informed consent/assent must also be obtained from the minor.
You may not qualify if…
- None.
Full record on ClinicalTrials.gov
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