NCT01374984

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

Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label Phase 4 study designed to collect additional data to assess the safety and efficacy of VIGIV \[CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution\] in the first 100 consented patients treated with VIGIV.

Conditions

• Complication of Smallpox Vaccination

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-08-01
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2011-06-17
• Last updated: 2025-10-08

Regulatory

• FDA-regulated drug study