Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency

Key Inclusion Criteria:

• Written informed consent, age-adapted

• Male or female aged 1 to 70 years

• Diagnosis of primary humoral immunodeficiency

• No prior immunoglobulin substitution therapy

• IgG level of <5 g/L at screening

• Women of childbearing potential must use medically approved contraception and musthave a negative urine pregnancy test at screening

Key Exclusion Criteria:

• Evidence of serious infection between screening and first treatment

• Bleeding disorders that require medical treatments

• Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or aclinically significant defect in cell mediated immunity

• Any condition likely to interfere with evaluation of the study drug or satisfactoryconduct of the trial