Clinical Trial

VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection

Enrolling by Invitation
View on ClinicalTrials.gov →
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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2011-06-15; most recent amendment 2026-05-08.
Status change: Suspended → Enrolling by Invitation 2015-04-22
Status change: Enrolling by Invitation → Suspended 2012-07-23
Trial Details
NCT Number NCT01374984
Lead Sponsor Emergent BioSolutions
Collaborators: Centers for Disease Control and Prevention
Conditions Complication of Smallpox Vaccination
Enrollment 100 participants
Start Date 2007-08
Primary Completion 2027-08 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-05-12