Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients

Inclusion Criteria:

• Written informed consent/assent obtained from participant/participant's parent(s) orlegally acceptable representative indicating that they understand the purpose of andprocedures required for the study and are willing to participate in it.

• Confirmed clinical diagnosis of a PID, requiring treatment with IVIg and havedocumented agammaglobulinemia (defined as the total absence of one or more classesof antibodies) or hypogammaglobulinemia (defined as low levels of one or moreclasses [that is at least 2 standard deviations under the mean level per age])

• Male or female, ages 2 to 70 years at screening

• Received 200 to 800 mg/kg of a commercially available IVIg therapy in the range of 21- or 28-day intervals (±3 days or ±4 days, respectively) for at least 3 infusioncycles prior to screening

• At least 2 documented IgG trough levels while receiving an IVIg, of greater than orequals to (>=) 6 gram per liter (g/L) obtained at 2 infusion cycles within 12 months (1 must be within 6 months) prior to Informed Consent Form (ICF) signature

• Participant is willing to comply all requirements of the protocol.

• Females of child-bearing potential with a negative urine pregnancy test and whoagree to employ adequate birth control measures during the study

• Authorization to access personal health information

• Participant previously participating in a clinical trial with another experimentalIVIg may be enrolled if they have received stable commercially available IVIgtherapy for at least 3 infusion cycles (21 or 28 days) prior to screening

• Participant currently on treatment with any subcutaneous immunoglobulin (SCIG) canbe enrolled if they are switched to stable commercially available IVIg therapy forat least 3 infusion cycles (21 or 28 days) prior to screening

Exclusion Criteria:

• Newly diagnosed PID and and naïve to IgG replacement therapy

• Dysgammaglobulinemia (defined as a deficiency in one or more classes of antibodies,but not severe enough to require substitutive therapy) or isolated IgG subclassdeficiency or profound primary T-cell deficiency (defined as the absence or severereduction of T lymphocytes [CD3+ <300 cells per cubic millimeter (cell/mm3)] and anabsent or particularly low proliferative response [10% of the lower normal range] tophytohaemagglutinin P [PHA])

• Has history of severe or serious reactions or hypersensitivity to IVIg or otherinjectable forms of IgG

• Has history of thrombotic events (including deep vein thrombosis, cerebrovascularaccident, pulmonary embolism, transient ischemic attacks, or myocardial infarction),as defined by at least 1 event in participant's lifetime

• Has IgA deficiency with documented antibodies to IgA

• Have received blood products that have not undergone viral inactivation measureswithin 12 months prior to Informed Consent Form (ICF) signature

• Has significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia

• Has an acute infection as documented by culture or diagnostic imaging and/or a bodytemperature >= 38 degree Celsius (°C) (>=100.4 degree Fahrenheit (°F) within 7 daysprior to screening

• Has acquired immunodeficiency syndrome (AIDS) and/or hepatitis B/C active disease atICF signature

• Has levels of Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), 2.5 times of the upper limit of normal for the laboratory designated for the study

• Using an implanted venous access device

• Has profound anemia (haemoglobin less than10 gram per deciliter [g/dl]) orpersistent severe neutropenia (<= 1000 neutrophils per millimeter cube (mm^3) orlymphopenia of less than 500 cells per microliter

• Have severe chronic condition such as renal failure (creatinine concentration > 2.0times the upper limit of normal) with proteinuria, congestive heart failure (NewYork Heart Association III/IV), cardiomyopathy, cardiac arrhythmia associated withthromboembolic events (e.g., atrial fibrillation), unstable or advanced ischemicheart disease, hyper viscosity, or any other condition that the Investigatorbelieves is likely to interfere with evaluation of the study drug or withsatisfactory conduct of the trial. Normal values for serum creatinine are thefollowing: a) Female (18+ years): 45 - 84 micromole per liter (mcmol/L) or 0.51 - 0.95 milligrams per deciliter (mg/dl); b) Male (18+ years): 59 - 103 mcmol/L or 0.67

• 1.17 mg/dl

• Has history of a malignant disease other than properly treated carcinoma in situ ofthe cervix or basal cell or squamous cell carcinoma of the skin within 24 monthsprior to ICF signature

• Has history of pharmacoresistant epilepsy or multiple episodes of migraine (definedas at least 1 episode within 6 months of ICF signature) not completely controlled bymedication

• Participants must not be receiving steroids (oral or parenteral daily dose of >= 0.15 milligram per kilogram per day (mg/kg/day) of prednisone or equivalent) orother immunosuppressive drugs or chemotherapy

• Females who are pregnant, breast feeding or planning a pregnancy during the courseof the study. Women who become pregnant during the study will be withdrawn from thestudy

• Has participated in another clinical study within 3 weeks prior to study ICFsignature

• Has history of drug or alcohol abuse within the 6 months before screening

• Has Employed or a direct relative of an employee of the CRO, the study site, or theSponsor

• Previously treated under this protocol

• Unable to provide informed consent or provide informed consent by a legallyauthorized representative