Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection

• Status: Approved for marketing
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to assess VariZIG™ for the treatment of patients at risk for developing serious complications from chicken pox.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cangene Corporation
• Treatments: Antibodies; gamma-Globulins; Immune Sera; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Signed informed consent.

• Cangene Corporation VariZIG™ release requirement.

• Any of the following at-risk patients exposed to varicella within the previous 96 hours:

• Immunocompromised pediatric or adult patients.

• Neonates (less than 1 year of age) and pre-term infants.

• Pregnant women.

• Newborns whose mothers had VZV infection shortly before delivery (< 5 days) or after (< 2 days) delivery.

• Healthy non-immune adults

Exclusion Criteria:

• Hypersensitivity to blood or blood products, including intravenous (IV) or intramuscular (IM) human immunoglobulin preparations.

• Selective immunoglobulin A (IgA) deficiency.

• Evidence of VZV infection.

• Evidence of zoster infection.

• Known immunity to VZV(previous varicella infection or varicella vaccination)

• Severely thrombocytopenic ( platelets < 50 x 10x9 / L )