Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency

Phase III Study of Immune Globulin Intravenous (Human) IGIV-SN in Pediatric Subjects With Primary Humoral Immunodeficiency

To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)

Inclusion Criteria:

• Pediatric subjects with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia
• Subject is willing to comply with all requirements of protocol
• Authorization to access personal health information

Exclusion Criteria:

• Subject has secondary immunodeficiency
• Subject has a history of repeated reactions or hypersensitivity to IGIV or other injectable forms of IgG
• Subject has significant protein loss from enteropathy, nephrotic syndrome or lymphangiectasia