Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16

Inclusion Criteria: * Written informed consent/Assent * Male or female between 2 and 16 years, inclusive, at time of Signing Informed Consent/Assent * Have a confirmed and documented clinical diagnosis of Primary Immune Deficiency Disorder, including hypogammaglobulinemia or agammaglobulinemia. * Have received IGIV therapy which was maintained at a steady dose (± 25% of the mean dose) for at least 3 months prior to study entry, and have maintained a trough IgG level at least 500mg/dL prior to receiving BIVIGAM®. * Subjects and/or parents/legal guardians must be able to understand and adhere to the study visit schedule and all other protocol requirements. Exclusion Criteria: * Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction). * Known intolerance to proteins of human origin or known allergic reactions to components of the study product(s). * Any previous randomization/participation in this clinical study must be discussed with and approved by the medical director (or designee). * Inability or lacking motivation to participate in the study. * Medical condition, laboratory finding, or physical exam finding (specify, e.g., vital signs outside of specific range that precludes participation. Per lab results at the Screening visit through Baseline. * Confirmed Screening visit laboratory results ˃2.5 X ULN as defined for pediatric populations for any of the following: ALT (alanine aminotransferase/SGPT), AST (aspartate aminotransferase/SGOT)…