VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Inf… (NCT01374984) | Clinical Trial Compass
By InvitationNot Applicable
VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
100 participantsStarted 2007-08
Plain-language 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.
Who can participate
SexALL
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Inclusion Criteria:
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.
Exclusion Criteria:
None.
What they're measuring
1
Resolution of vaccinia infection complications
Timeframe: At hospital discharge (if not fully resolved at discharge then 1 month or 6 months as applicable)