Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders

Inclusion Criteria: * Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration * Diagnosis of a PID disorder as defined by World Health Organization criteria for which the subject has been receiving a regimen of IGIV infusions every 21 to 28 days over a period of at least 4 months pre-study at a dose of 300-600 mg/kg body weight * Subjects \> 24 months of age * A negative serum pregnancy test for any female subject who is of childbearing potential. Exclusion Criteria: * Subjects sero-positive at enrollment for one or more of the following: hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (HCV), antibodies to human immunodeficiency virus (HIV) Types 1 or 2 * Subjects with levels of alanine amino transferase (ALT) and aspartate amino transferase (AST) \> 2.5 times the upper limit of normal for the testing laboratory. An AST \> 2.5 times the upper limit of normal is allowable, if the ALT does not exceed the upper limit of the reference range for the testing laboratory * Subjects with neutropenia (defined as an ANC \>= 1,000/mm3) * Subjects with serum creatinine levels greater than two times the upper limit of normal for age and gender * Subjects with malignancy or a history of malignancy * Subjects who received any blood or blood product exposure other than an IGIV and/or immune serum globulin (ISG) preparation within the 6 months prio…