CARES10: Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients

• Sponsor: Kedrion S.p.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03961009
• Collaborator: (none)
• Enrollment: 47
• Locations: 11
• Arm: 1
• Actual Duration (Months): 19.7
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).

Condition or Disease	Intervention/Treatment	Phase
Primary Immunodeficiency Disease	Biological: Kedrion IVIG 10%	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety and Pharmacokinetics of Kedrion Intravenous Immunoglobulin (IVIg) 10% in Primary Immunodeficiency Disease (PID) Patients
• Actual Study Start Date: Apr 30, 2019
• Actual Primary Completion Date: Dec 21, 2020
• Actual Study Completion Date: Dec 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kedrion IVIG 10% Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 milligrams per kilogram (mg/kg) body weight on every 21 or 28 days for period of 48 weeks.	Biological: Kedrion IVIG 10%; Kedrion intravenous immunoglobulin (IVIg) 10%

Outcome Measures

Primary Outcome Measures

1. Incidence Rate of Acute Serious Bacterial Infections (ABSIs) [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

   Incidence rate was defined as the mean number of acute serious bacterial infections (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) per participant-year according to pre-specified criteria.

Secondary Outcome Measures

1. Serum Immunoglobulin G (IgG) Trough Levels [At baseline, Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

   The serum IgG trough levels were collected and analyzed at a central laboratory.

2. Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) [At baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)]

   IgG subclasses levels (IgG1, IgG2, IgG3, IgG4) were collected and analyzed at a central laboratory.

3. Number of Participants With Total Immunoglobulin G (IgG) Trough Levels Less Than or Equal to (<=) 6 Grams/Liter (g/L) Criteria [Up to 12 months]

   Number of participants with Total IgG trough levels <= 6 g/L criteria were reported.

4. Anti-Tetanus Toxoid Antibody Levels [Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)]

   The anti-tetanus toxoid antibody levels were collected and analyzed at a central laboratory. This antibody level was measured in international units per milliliter (IU/mL).

5. Anti-Pneumococcal Capsular Polysaccharide Antibody Levels [Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)]

   Anti-pneumococcal capsular polysaccharide antibody levels for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 were collected and analyzed at a central laboratory.

6. Anti-Measles Antibody Levels [Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)]

   The anti-measles antibody levels were collected and analyzed at a central laboratory.

7. Anti-Haemophilus Influenza Type B Antibody Levels [Baseline, Weeks 16, 32 and 48 (28 -day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)]

   The anti-haemophilus influenza type B antibody levels were collected and analyzed at central laboratory.

8. Incidence Rate of Any Infection Other Than Acute Serious Bacterial Infections [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

   Incidence rate was defined as the mean number of any infection other than acute serious bacterial infections (bacterial pneumonia, bacteraemia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) per participant-year. Incidence rate of any infection other than acute bacterial serious infections collected by the participant/participants parent(s)/legal guardian(s) in the participant diary or during clinic visit was reported.

9. Duration of Any Infection Other Than Acute Serious Bacterial Infections [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

   Duration of any infection other than serious acute bacterial infections (in days) was calculated as date of stop of infection - date of start of infection + 1. Duration of any infection other than serious acute bacterial infections collected by the by the participant/participants parent(s)/legal guardian(s) in the participant diary or during clinic visit was reported.

10. Incidence Rate of Fever Episodes [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    Incidence rate was defined as the mean number of fever episodes per participant-year. Incidence rate of fever episodes collected by the participant/participant's parent(s)/legal guardian(s) in the participant diary or during clinic visit were reported.

11. Duration of Fever Episodes in Participants [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    Duration of fever episodes in participants was reported.

12. Duration of Overall Participants Hospitalization [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    Duration of overall participants hospitalization was reported.

13. Duration of Participants Hospitalization Due to Infection [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    Duration of participants hospitalization due to infection was reported.

14. Incidence Rate of Antibiotics Episodes for Treatment of Any Kind of Infections [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    Incidence rate was defined as the mean number of antibiotics episodes per participant year. Incidence rate of participants on antibiotics for treatment of any kind of infections was reported.

15. Duration of Participants on Antibiotics for Treatment of Any Kind of Infection [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    Duration of participants on antibiotics for treatment of any kind of infection was reported.

16. Duration of Missed School/Work/Other Major Activities Due to Infections [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    Duration of missed school/work/other major activities due to infections was reported.

17. Pediatric Quality of Life Inventory (PedsQL) Score [Baseline, Week 24 (21-day dosing schedule and 28-day dosing schedule), Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    23-item PedsQL generic core scales was a modular approach to measure health-related Quality of Life (QoL) in healthy children, adolescents and those with acute and chronic health conditions. The total scale score (23 items) consisted of Physical Health Summary Score (8 items) and Psychosocial Health SummaryScore (15 items). Physical health summary included Physical Functioning (8 items) and Psychosocial health summary score included Emotional Functioning (5 items), Social Functioning (5 items) and School Functioning (5 items). Items were scored on a 5 point Likert-type response scale: 0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; and 4=almost always a problem). Once scored, items were reverse scored and linearly transformed to a 0-100 scale, where higher scores indicated better QoL. The overall range for total PedsQL score (23 items) was 0 to 100, with higher score indicated better QoL. Data for 18-25 years and >25 years age group was reported.

18. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAE was defined as an AE with an onset that occurs after receiving study drug. Any TEAE included participants with both serious and non-serious TEAEs.

19. Number of TEAEs and Serious TEAEs [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. A SAE was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. A TEAE was defined as an AE with an onset that occurs after receiving study drug. Number of TEAEs and Serious TEAEs were reported.

20. Number of Drug Related Infusion Adverse Events (AEs) [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Number of drug related infusion AEs were reported.

21. Percentage of Participants Who Experienced at Least One Drug Related Infusion Adverse Events (AEs) [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    Percentage of participants who experienced at least one drug related infusion AEs were reported.

22. Number of Infusions With Decreased Infusion Rate Due to Adverse Events (AEs) [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    Number of infusions with decreased infusion rate due to AEs were reported.

23. Number of Infusions With One or More Infusion Associated Adverse Events (AEs) [Baseline up to Week 52]

    The number of infusions with one or more infusion associated AEs were reported collectively for 21 and 28-day dosing schedule up to Week 52.

24. Number of Participants With Clinically Significant Changes From Baseline in Vital Signs [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    Vital signs included body temperature, systolic and diastolic blood pressure, heart rate and weight. The systolic and diastolic blood pressure and pulse rate was measured after the participants have in a rested at least 3 minutes in seated position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in vital signs were reported.

25. Number of Participants With Clinically Significant Changes From Baseline in Physical Examinations [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    Physical examination included the examination of general appearance, skin, neck, eyes, ears, nose, throat, cardiovascular assessment including rhythm, and presence of other cardiac abnormalities (for example gallops, murmurs, cardiomegaly), respiratory system, gastrointestinal system, genitourinary system and musculoskeletal system. Clinical significance was decided by the investigator. The number of participants with clinically significant changes from baseline in physical examination were reported.

26. Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters [Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

    Laboratory parameters included chemistry, hematology and urinalysis. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in laboratory parameters were reported.

27. Number of Participants With Positive Coomb's Test at Week 16 (28-day Dosing Schedule) and Week 18 (21-day Dosing Schedule) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)]

    Intravascular hemolysis testing was performed by using coomb's test. The coomb's assessment was performed at a central laboratory.

28. Number of Participants With Positive Urine Hemosiderin Test [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)]

    Number of participants with positive urine hemosiderin test were reported.

29. Number of Participants With Abnormal Plasma-free Haemoglobin Level [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)]

    Number of participants with plasma-free haemoglobin level more than or equal to (>=) 69 milligrams per deciliter (mg/dL) were consisdered as abormal and were reported.

30. Number of Participants With Abnormal Serum Haptoglobin Level [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)]

    Number of participants with abnormal serum haptoglobin level were reported.

31. Maximum Observed Serum Concentration (Cmax) of Total Immunoglobulin G (IgG) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Cmax was obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported.

32. Elimination Half-Life (t1/2) of Total IgG [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported.

33. Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Total IgG [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. Both baseline corrected and un-corrected data was reported.

34. Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total IgG [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported.

35. Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Total IgG [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule. Both baseline corrected and un-corrected data was reported.

36. Volume of Distribution (Vd) of Total IgG [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Vd was defined as the the theoretical volume in which the total amount of total IgG would need to be uniformly distributed to produce the desired blood concentration of a total IgG. Both baseline corrected and un-corrected data was reported.

37. Steady State Clearance (CLss) of Total IgG [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Clearance of a total IgG was a measure of the rate at which a total IgG is metabolized or eliminated by normal biological processes. CLss of total IgG was measured in milliliters per hour per kilogram (mL/hr/kg). Both baseline corrected and un-corrected data was reported.

38. Minimum Observed Serum Concentration (Cmin) of Total IgG [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported.

39. Time to Reach the Maximum Serum Concentration (Tmax) of Total IgG [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Tmax was obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported.

40. Elimination Rate Constant (Kel) of Total IgG [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported.

41. Average Concentration of Total IgG Over the Dosing Interval (Cavg) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Average concentration of total IgG over the dosing interval (Cavg) was reported. Both baseline corrected and un-corrected data was reported.

42. Percentage Peak Trough Fluctuation of Total IgG [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    The peak trough fluctuation within complete dosing interval at steady state of total IgG was reported. Both baseline corrected and un-corrected data was reported.

43. Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Tetanus Toxoid Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Cmax was obtained directly from the concentration versus time curve.

44. Elimination Half-Life (t1/2) of Antigen-Specific Tetanus Toxoid Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.

45. Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Tetanus Toxoid Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. The AUC0-t of antigen-specific tetanus toxoid antibodies was measured in hour*international units per milliliter (hr*IU/mL).

46. Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Tetanus Toxoid Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.

47. Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Tetanus Toxoid Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule.

48. Volume of Distribution (Vd) of Antigen-Specific Tetanus Toxoid Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Vd was defined as the the theoretical volume in which the total amount of antigen-specific tetanus toxoid antibodies would need to be uniformly distributed to produce the desired blood concentration of antigen-specific tetanus toxoid antibodies. The Vd of antigen-specific tetanus toxoid antibodies was measured in milligrams*milliliter per international unit*kilogram (mg*mL/IU*kg).

49. Steady State Clearance (CLss) of Antigen-Specific Tetanus Toxoid Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Clearance of a antigen-specific tetanus toxoid antibodies was a measure of the rate at which a antigen-specific tetanus toxoid antibodies are metabolized or eliminated by normal biological processes. The CLss of antigen-specific tetanus toxoid antibodies was reported. The CLss of antigen-specific tetanus toxoid antibodies was measured in milligrams*milliliter per hour*international unit*kilogram (mg*mL/hr*IU*kg).

50. Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Tetanus Toxoid Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve.

51. Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Tetanus Toxoid Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Tmax was obtained directly from the concentration versus time curve.

52. Elimination Rate Constant (Kel) of Antigen-Specific Tetanus Toxoid Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.

53. Average Concentration of Antigen-Specific Tetanus Toxoid Antibodies Over the Dosing Interval (Cavg) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Average concentration of antigen-specific tetanus toxoid antibodies over the dosing interval (Cavg) was reported.

54. Percentage Peak Trough Fluctuation of Antigen-Specific Tetanus Toxoid Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    The peak trough fluctuation within complete dosing interval at steady state of antigen-specific tetanus toxoid antibodies was reported.

55. Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Cmax was obtained directly from the concentration versus time curve.

56. Elimination Half-Life (t1/2) of Antigen-Specific Haemophilus Influenza Type B Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.

57. Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Haemophilus Influenza Type B Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. AUC0-t of antigen-specific haemophilus influenza Type B Antibodies was measured in hour*microgram per milliliter (hr*mcg/mL).

58. Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Haemophilus Influenza Type B Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.

59. Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Haemophilus Influenza Type B Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule.

60. Volume of Distribution (Vd) of Antigen-Specific Haemophilus Influenza Type B Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Vd was defined as the the theoretical volume in which the total amount of antigen-specific haemophilus influenza type B antibodies would need to be uniformly distributed to produce the desired blood concentration of a antigen-specific haemophilus influenza type B antibodies.

61. Steady State Clearance (CLss) of Antigen-Specific Haemophilus Influenza Type B Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Clearance of antigen-specific haemophilus influenza type B antibodies was a measure of the rate at which antigen-specific haemophilus influenza type B antibodies were metabolized or eliminated by normal biological processes. CLss of antigen-specific haemophilus influenza type B antibodies was measured in milliliter per hour per kilogram (mL/hr/kg).

62. Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Haemophilus Influenza Type B Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve.

63. Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Tmax was obtained directly from the concentration versus time curve.

64. Elimination Rate Constant (Kel) of Antigen-Specific Haemophilus Influenza Type B Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.

65. Average Concentration of Antigen-Specific Haemophilus Influenza Type B Antibodies Over the Dosing Interval (Cavg) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Average concentration of antigen-specific haemophilus influenza type B antibodies over the dosing interval (Cavg) was reported.

66. Percentage Peak Trough Fluctuation of Antigen-Specific Haemophilus Influenza Type B Antibodies [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    The peak trough fluctuation within complete dosing interval at steady state of antigen-specific haemophilus influenza type B antibodies was reported.

67. Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Cmax was obtained directly from the concentration versus time curve. The Cmax for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8, serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.

68. Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The t1/2 for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.

69. Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. AUC0-t of antigen-pneumococcal capsular polysaccharide was measured in hour*microgram per milliliter (hr*mcg/mL). The AUC0-t for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.

70. Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The AUC0-inf for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20 serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.

71. Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule. The AUCtau for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.

72. Volume of Distribution (Vd) of of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Vd was defined as the the theoretical volume in which the total amount of anti-pneumococcal capsular polysaccharide would need to be uniformly distributed to produce the desired blood concentration of a anti-pneumococcal capsular polysaccharide. The Vd for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.

73. Steady State Clearance (CLss) of Anti-pneumococcal Capsular Polysaccharide Antibodies (Overall SP Serotypes) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Clearance of a anti-pneumococcal capsular polysaccharide antibodies was a measure of the rate at which a anti-pneumococcal capsular polysaccharide antibodies are metabolized or eliminated by normal biological processes. The CLss of anti-pneumococcal capsular polysaccharide antibodies was reported. The CLss of anti-pneumococcal capsular polysaccharide antibodies was measured in milligrams*milliliter per hour*international unit*kilogram (mg*mL/hr*IU*kg). The CLss for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.

74. Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve. The Cmin for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.

75. Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Tmax was obtained directly from the concentration versus time curve. The Tmax for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.

76. Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The Kel for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20 serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.

77. Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    Average concentration of anti-pneumococcal capsular polysaccharide over the dosing interval (Cavg) was reported. The Cavg for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.

78. Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

    The peak trough fluctuation within complete dosing interval at steady state of anti-pneumococcal capsular polysaccharide was reported. The peak trough fluctuation for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

• Confirmed clinical diagnosis of a PID, requiring treatment with IVIg and have documented agammaglobulinemia (defined as the total absence of one or more classes of antibodies) or hypogammaglobulinemia (defined as low levels of one or more classes [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 infusion cycles prior to screening

• At least 2 documented IgG trough levels while receiving an IVIg, of greater than or equals 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 who agree to employ adequate birth control measures during the study

• Authorization to access personal health information

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

• Participant currently on treatment with any subcutaneous immunoglobulin (SCIG) can be enrolled if they are switched to stable commercially available IVIg therapy for at 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 subclass deficiency or profound primary T-cell deficiency (defined as the absence or severe reduction of T lymphocytes [CD3+ <300 cells per cubic millimeter (cell/mm3)] and an absent or particularly low proliferative response [10% of the lower normal range] to phytohaemagglutinin P [PHA])

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

• Has history of thrombotic events (including deep vein thrombosis, cerebrovascular accident, 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 measures within 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 body temperature >= 38 degree Celsius (°C) (>=100.4 degree Fahrenheit (°F) within 7 days prior to screening

• Has acquired immunodeficiency syndrome (AIDS) and/or hepatitis B/C active disease at ICF 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]) or persistent severe neutropenia (<= 1000 neutrophils per millimeter cube (mm^3) or lymphopenia of less than 500 cells per microliter

• Have severe chronic condition such as renal failure (creatinine concentration > 2.0 times the upper limit of normal) with proteinuria, congestive heart failure (New York Heart Association III/IV), cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g., atrial fibrillation), unstable or advanced ischemic heart disease, hyper viscosity, or any other condition that the Investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial. Normal values for serum creatinine are the following: 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 of the cervix or basal cell or squamous cell carcinoma of the skin within 24 months prior to ICF signature

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

• 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) or other immunosuppressive drugs or chemotherapy

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

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

• 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 the Sponsor

• Previously treated under this protocol

• Unable to provide informed consent or provide informed consent by a legally authorized representative

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allergy Associates of the Palm Beaches	North Palm Beach	Florida	United States	33408
2	Rush University Medical Center	Chicago	Illinois	United States	60612
3	Dr. Henry J. Kanarek - Allergy, Asthma & Immunology	Overland Park	Kansas	United States	66211
4	Midwest Immunology Clinic and Infusion Center	Plymouth	Minnesota	United States	55446
5	Allergy and Immunology Associates	Little Silver	New Jersey	United States	07739
6	University of Buffalo	Buffalo	New York	United States	14203
7	Optimed Research	Columbus	Ohio	United States	43235
8	Ohio Clinical Research Associates, Inc.	Mayfield Heights	Ohio	United States	44124
9	Toledo Institute of Clinical Research Inc	Toledo	Ohio	United States	43617
10	Allergy Partners of North Texas Research	Dallas	Texas	United States	75230
11	AARA Research Center	Dallas	Texas	United States	75231

Sponsors and Collaborators

• Kedrion S.p.A.

Investigators

• Principal Investigator: Medical Director, Kedrion SpA

Study Documents (Full-Text)

• Study Protocol - Nov 30, 2020
• Statistical Analysis Plan - Sep 15, 2020

More Information

Publications

None provided.

• Responsible Party: Kedrion S.p.A.
• ClinicalTrials.gov Identifier: NCT03961009
• Other Study ID Numbers: KIG10_US3_PID01
• First Posted: May 23, 2019
• Last Update Posted: Jan 27, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kedrion S.p.A.: Immunoglobulin; Kedrion IVIg10%; IgG antibodies; Agammaglobulinemia; Hypogammaglobulinemia
• Additional relevant MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes

Study Results

Participant Flow

Recruitment Details	This study was conducted at 11 sites in the United States from 30 April 2019 (first participant first visit) to 21 December 2020 (last participant last visit).
Pre-assignment Detail	A total of 59 participants were screened, out of which 47 participants were enrolled and received the treatment in this study.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 milligrams per kilogram (mg/kg) body weight on every 21 or 28 days for period of 48 weeks.
Period Title: Overall Study
STARTED	47
COMPLETED	47
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Overall Participants	47
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.6 (12.90)
Sex: Female, Male (Count of Participants)
Female	30 63.8%
Male	17 36.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 4.3%
Not Hispanic or Latino	44 93.6%
Unknown or Not Reported	1 2.1%
Race/Ethnicity, Customized (Count of Participants)
White	45 95.7%
Mexican	1 2.1%
White and African American	1 2.1%

Outcome Measures

1. Primary Outcome

Title	Incidence Rate of Acute Serious Bacterial Infections (ABSIs)
Description	Incidence rate was defined as the mean number of acute serious bacterial infections (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) per participant-year according to pre-specified criteria.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

The FAS included all participants who had received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
21-day dosing schedule	0.0 (0.0)
28-day dosing schedule	0.0 (0.0)

2. Secondary Outcome

Title	Serum Immunoglobulin G (IgG) Trough Levels
Description	The serum IgG trough levels were collected and analyzed at a central laboratory.
Time Frame	At baseline, Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
Baseline	10.317 (3.1342)
21-day dosing schedule: Week 51	11.433 (1.7935)
28-day dosing schedule: Week 52	10.297 (2.1167)

3. Secondary Outcome

Title	Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
Description	IgG subclasses levels (IgG1, IgG2, IgG3, IgG4) were collected and analyzed at a central laboratory.
Time Frame	At baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
IgG1: Baseline	5.798 (1.7504)
IgG1: 28-day dosing schedule: Week 16	5.605 (1.6115)
IgG1: 21-day dosing schedule: Week 18	5.968 (1.5094)
IgG1: 28-day dosing schedule: Week 32	5.679 (1.3965)
IgG1: 21-day dosing schedule: Week 30	5.979 (0.9430)
IgG1: 28-day dosing schedule: Week 48	5.634 (1.4139)
IgG1: 21-day dosing schedule: Week 48	6.210 (0.9430)
IgG2: Baseline	3.527 (0.9635)
IgG2: 28-day dosing schedule: Week 16	3.419 (0.8803)
IgG2: 21-day dosing schedule: Week 18	4.113 (1.0155)
IgG2: 28-day dosing schedule: Week 32	3.458 (0.7705)
IgG2: 21-day dosing schedule: Week 30	4.079 (0.4975)
IgG2: 28-day dosing schedule: Week 48	3.475 (0.7848)
IgG2: 21-day dosing schedule: Week 48	4.234 (0.5649)
IgG3: Baseline	0.405 (0.3109)
IgG3: 28-day dosing schedule: Week 16	0.351 (0.3459)
IgG3: 21-day dosing schedule: Week 18	0.271 (0.1239)
IgG3: 28-day dosing schedule: Week 32	0.352 (0.3461)
IgG3: 21-day dosing schedule: Week 30	0.249 (0.0885)
IgG3: 28-day dosing schedule: Week 48	0.329 (0.3268)
IgG3: 21-day dosing schedule: Week 48	0.253 (0.0658)
IgG4: Baseline	0.2213 (0.12779)
IgG4: 28-day dosing schedule: Week 16	0.2388 (0.09656)
IgG4: 21-day dosing schedule: Week 18	0.2744 (0.06415)
IgG4: 28-day dosing schedule: Week 32	0.2425 (0.09290)
IgG4: 21-day dosing schedule: Week 30	0.2838 (0.06412)
IgG4: 28-day dosing schedule: Week 48	0.2396 (0.09355)
IgG4: 21-day dosing schedule: Week 48	0.2950 (0.05381)

4. Secondary Outcome

Title	Number of Participants With Total Immunoglobulin G (IgG) Trough Levels Less Than or Equal to (<=) 6 Grams/Liter (g/L) Criteria
Description	Number of participants with Total IgG trough levels <= 6 g/L criteria were reported.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study medication.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
Count of Participants [Participants]	1 2.1%

5. Secondary Outcome

Title	Anti-Tetanus Toxoid Antibody Levels
Description	The anti-tetanus toxoid antibody levels were collected and analyzed at a central laboratory. This antibody level was measured in international units per milliliter (IU/mL).
Time Frame	Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
Baseline	2.526 (1.4158)
28-day dosing schedule: Week 16	2.589 (2.0770)
21-day dosing schedule: Week 18	2.654 (0.9853)
28-day dosing schedule: Week 32	2.345 (0.8820)
21-day dosing schedule: Week 30	2.643 (0.9374)
28-day dosing schedule: Week 48	2.207 (0.8565)
21-day dosing schedule: Week 48	3.299 (1.3307)

6. Secondary Outcome

Title	Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Description	Anti-pneumococcal capsular polysaccharide antibody levels for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 were collected and analyzed at a central laboratory.
Time Frame	Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
Baseline: Serotype 1	2.66 (4.820)
28-day dosing schedule: Week 16: Serotype 1	1.55 (1.481)
21-day dosing schedule: Week 18: Serotype 1	4.89 (5.740)
28-day dosing schedule: Week 32: Serotype 1	1.66 (2.114)
21-day dosing schedule: Week 30: Serotype 1	4.74 (5.692)
28-day dosing schedule: Week 48: Serotype 1	1.49 (1.707)
21-day dosing schedule: Week 48: Serotype 1	4.28 (4.926)
Baseline: Serotype 12	0.81 (1.103)
28-day dosing schedule: Week 16: Serotype 12	0.75 (1.201)
21-day dosing schedule: Week 18: Serotype 12	0.58 (0.175)
28-day dosing schedule: Week 32: Serotype 12	0.86 (1.280)
21-day dosing schedule: Week 30: Serotype 12	0.55 (0.120)
28-day dosing schedule: Week 48: Serotype 12	0.82 (1.159)
21-day dosing schedule: Week 48: Serotype 12	0.59 (0.090)
Baseline: Serotype 14	9.04 (20.383)
28-day dosing schedule: Week 16: Serotype 14	11.88 (29.791)
21-day dosing schedule: Week 18: Serotype 14	6.11 (3.302)
28-day dosing schedule: Week 32: Serotype 14	11.96 (26.509)
21-day dosing schedule: Week 30: Serotype 14	5.76 (2.752)
28-day dosing schedule: Week 48: Serotype 14	13.02 (34.794)
21-day dosing schedule: Week 48: Serotype 14	6.14 (3.408)
Baseline: Serotype 17	2.55 (4.249)
28-day dosing schedule: Week 16: Serotype 17	2.08 (3.977)
21-day dosing schedule: Week 18: Serotype 17	3.25 (3.146)
28-day dosing schedule: Week 32: Serotype 17	1.89 (2.952)
21-day dosing schedule: Week 30: Serotype 17	3.38 (4.058)
28-day dosing schedule: Week 48: Serotype 17	1.76 (3.043)
21-day dosing schedule: Week 48: Serotype 17	3.09 (3.111)
Baseline: Serotype 19	3.71 (5.275)
28-day dosing schedule: Week 16: Serotype 19	4.95 (8.597)
21-day dosing schedule: Week 18: Serotype 19	3.20 (1.074)
28-day dosing schedule: Week 32: Serotype 19	3.71 (4.200)
21-day dosing schedule: Week 30: Serotype 19	2.88 (0.686)
28-day dosing schedule: Week 48: Serotype 19	4.25 (7.328)
21-day dosing schedule: Week 48: Serotype 19	2.86 (0.958)
Baseline: Serotype 2	2.38 (2.294)
28-day dosing schedule: Week 16: Serotype 2	2.04 (1.618)
21-day dosing schedule: Week 18: Serotype 2	3.34 (3.701)
28-day dosing schedule: Week 32: Serotype 2	2.11 (1.502)
21-day dosing schedule: Week 30: Serotype 2	3.48 (4.071)
28-day dosing schedule: Week 48: Serotype 2	2.01 (1.283)
21-day dosing schedule: Week 48: Serotype 2	3.35 (3.342)
Baseline: Serotype 20	2.71 (2.296)
28-day dosing schedule: Week 16: Serotype 20	2.63 (3.007)
21-day dosing schedule: Week 18: Serotype 20	3.05 (1.425)
28-day dosing schedule: Week 32: Serotype 20	2.76 (3.153)
21-day dosing schedule: Week 30: Serotype 20	3.16 (1.614)
28-day dosing schedule: Week 48: Serotype 20	2.51 (2.779)
21-day dosing schedule: Week 48: Serotype 20	3.05 (1.295)
Baseline: Serotype 22	1.33 (1.968)
28-day dosing schedule: Week 16: Serotype 22	0.84 (0.938)
21-day dosing schedule: Week 18: Serotype 22	2.36 (3.554)
28-day dosing schedule: Week 32: Serotype 22	0.83 (0.698)
21-day dosing schedule: Week 30: Serotype 22	2.78 (4.627)
28-day dosing schedule: Week 48: Serotype 22	0.88 (0.670)
21-day dosing schedule: Week 48: Serotype 22	2.51 (3.652)
Baseline: Serotype 23	1.65 (2.336)
28-day dosing schedule: Week 16: Serotype 23	1.42 (2.501)
21-day dosing schedule: Week 18: Serotype 23	1.28 (0.696)
28-day dosing schedule: Week 32: Serotype 23	1.37 (2.064)
21-day dosing schedule: Week 30: Serotype 23	1.34 (0.607)
28-day dosing schedule: Week 48: Serotype 23	1.47 (2.270)
21-day dosing schedule: Week 48: Serotype 23	1.50 (0.733)
Baseline: Serotype 26	1.72 (1.910)
28-day dosing schedule: Week 16: Serotype 26	1.32 (1.578)
21-day dosing schedule: Week 18: Serotype 26	1.83 (2.050)
28-day dosing schedule: Week 32: Serotype 26	1.36 (1.515)
21-day dosing schedule: Week 30: Serotype 26	1.70 (1.505)
28-day dosing schedule: Week 48: Serotype 26	1.39 (1.549)
21-day dosing schedule: Week 48: Serotype 26	1.73 (1.482)
Baseline: Serotype 3	2.41 (5.964)
28-day dosing schedule: Week 16: Serotype 3	1.41 (2.362)
21-day dosing schedule: Week 18: Serotype 3	4.74 (7.812)
28-day dosing schedule: Week 32: Serotype 3	1.42 (2.526)
21-day dosing schedule: Week 30: Serotype 3	4.24 (6.480)
28-day dosing schedule: Week 48: Serotype 3	1.12 (1.287)
21-day dosing schedule: Week 48: Serotype 3	4.69 (7.854)
Baseline: Serotype 34	1.83 (2.663)
28-day dosing schedule: Week 16: Serotype 34	1.34 (1.718)
21-day dosing schedule: Week 18: Serotype 34	3.33 (4.843)
28-day dosing schedule: Week 32: Serotype 34	1.30 (1.524)
21-day dosing schedule: Week 30: Serotype 34	3.73 (6.610)
28-day dosing schedule: Week 48: Serotype 34	1.35 (1.585)
21-day dosing schedule: Week 48: Serotype 34	3.04 (4.276)
Baseline: Serotype 4	0.88 (1.366)
28-day dosing schedule: Week 16: Serotype 4	0.54 (0.896)
21-day dosing schedule: Week 18: Serotype 4	0.57 (0.576)
28-day dosing schedule: Week 32: Serotype 4	1.07 (1.292)
21-day dosing schedule: Week 30: Serotype 4	0.66 (0.434)
28-day dosing schedule: Week 48: Serotype 4	0.89 (1.187)
21-day dosing schedule: Week 48: Serotype 4	0.68 (0.466)
Baseline: Serotype 43	1.36 (0.713)
28-day dosing schedule: Week 16: Serotype 43	1.07 (0.665)
21-day dosing schedule: Week 18: Serotype 43	1.51 (0.645)
28-day dosing schedule: Week 32: Serotype 43	1.08 (0.568)
21-day dosing schedule: Week 30: Serotype 43	1.43 (0.468)
28-day dosing schedule: Week 48: Serotype 43	1.12 (0.605)
21-day dosing schedule: Week 48: Serotype 43	1.61 (0.482)
Baseline: Serotype 5	3.64 (5.551)
28-day dosing schedule: Week 16: Serotype 5	2.68 (3.650)
21-day dosing schedule: Week 18: Serotype 5	6.56 (9.390)
28-day dosing schedule: Week 32: Serotype 5	2.65 (3.081)
21-day dosing schedule: Week 30: Serotype 5	6.51 (10.172)
28-day dosing schedule: Week 48: Serotype 5	2.44 (3.145)
21-day dosing schedule: Week 48: Serotype 5	5.41 (7.414)
Baseline: Serotype 51	2.82 (5.468)
28-day dosing schedule: Week 16: Serotype 51	1.66 (0.777)
21-day dosing schedule: Week 18: Serotype 51	5.96 (8.691)
28-day dosing schedule: Week 32: Serotype 51	1.65 (0.786)
21-day dosing schedule: Week 30: Serotype 51	5.70 (7.914)
28-day dosing schedule: Week 48: Serotype 51	1.58 (0.843)
21-day dosing schedule: Week 48: Serotype 51	5.86 (8.456)
Baseline: Serotype 54	3.04 (4.819)
28-day dosing schedule: Week 16: Serotype 54	2.33 (2.575)
21-day dosing schedule: Week 18: Serotype 54	5.04 (6.363)
28-day dosing schedule: Week 32: Serotype 54	2.95 (5.542)
21-day dosing schedule: Week 30: Serotype 54	4.86 (5.637)
28-day dosing schedule: Week 48: Serotype 54	2.53 (3.181)
21-day dosing schedule: Week 48: Serotype 54	4.13 (3.700)
Baseline: Serotype 56	3.41 (8.495)
28-day dosing schedule: Week 16: Serotype 56	2.55 (6.989)
21-day dosing schedule: Week 18: Serotype 56	5.84 (9.970)
28-day dosing schedule: Week 32: Serotype 56	2.17 (5.089)
21-day dosing schedule: Week 30: Serotype 56	5.38 (8.242)
28-day dosing schedule: Week 48: Serotype 56	2.54 (8.116)
21-day dosing schedule: Week 48: Serotype 56	6.00 (10.338)
Baseline: Serotype 57	5.73 (8.398)
28-day dosing schedule: Week 16: Serotype 57	5.11 (8.435)
21-day dosing schedule: Week 18: Serotype 57	23.40 (48.403)
28-day dosing schedule: Week 32: Serotype 57	5.46 (9.059)
21-day dosing schedule: Week 30: Serotype 57	7.00 (10.268)
28-day dosing schedule: Week 48: Serotype 57	5.31 (9.379)
21-day dosing schedule: Week 48: Serotype 57	8.17 (12.789)
Baseline: Serotype 68	1.08 (1.095)
28-day dosing schedule: Week 16: Serotype 68	0.86 (0.567)
21-day dosing schedule: Week 18: Serotype 68	1.66 (1.555)
28-day dosing schedule: Week 32: Serotype 68	0.93 (0.918)
21-day dosing schedule: Week 30: Serotype 68	1.36 (1.260)
28-day dosing schedule: Week 48: Serotype 68	0.76 (0.524)
21-day dosing schedule: Week 48: Serotype 68	1.33 (1.233)
Baseline: Serotype 70	1.98 (2.911)
28-day dosing schedule: Week 16: Serotype 70	1.43 (1.100)
21-day dosing schedule: Week 18: Serotype 70	3.56 (5.360)
28-day dosing schedule: Week 32: Serotype 70	1.53 (1.128)
21-day dosing schedule: Week 30: Serotype 70	3.53 (5.776)
28-day dosing schedule: Week 48: Serotype 70	1.48 (0.988)
21-day dosing schedule: Week 48: Serotype 70	3.19 (3.978)
Baseline: Serotype 8	2.10 (2.650)
28-day dosing schedule: Week 16: Serotype 8	1.67 (1.258)
21-day dosing schedule: Week 18: Serotype 8	3.51 (3.440)
28-day dosing schedule: Week 32: Serotype 8	1.86 (1.822)
21-day dosing schedule: Week 30: Serotype 8	3.66 (4.268)
28-day dosing schedule: Week 48: Serotype 8	1.82 (1.593)
21-day dosing schedule: Week 48: Serotype 8	3.63 (3.479)
Baseline: Serotype 9	0.96 (0.694)
28-day dosing schedule: Week 16: Serotype 9	0.77 (0.510)
21-day dosing schedule: Week 18: Serotype 9	1.03 (0.560)
28-day dosing schedule: Week 32: Serotype 9	0.81 (0.587)
21-day dosing schedule: Week 30: Serotype 9	0.99 (0.503)
28-day dosing schedule: Week 48: Serotype 9	0.75 (0.433)
21-day dosing schedule: Week 48: Serotype 9	1.03 (0.486)

7. Secondary Outcome

Title	Anti-Measles Antibody Levels
Description	The anti-measles antibody levels were collected and analyzed at a central laboratory.
Time Frame	Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)

Outcome Measure Data

Analysis Population Description

As per change in planned analysis, the anti-measles antibody level test was not performed.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	0

8. Secondary Outcome

Title	Anti-Haemophilus Influenza Type B Antibody Levels
Description	The anti-haemophilus influenza type B antibody levels were collected and analyzed at central laboratory.
Time Frame	Baseline, Weeks 16, 32 and 48 (28 -day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)

Outcome Measure Data

Analysis Population Description

FAS included all participants who had received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
Baseline	2.010 (1.1641)
28-day dosing schedule: Week 16	2.547 (1.7879)
21-day dosing schedule: Week 18	2.489 (0.9027)
28-day dosing schedule: Week 32	2.277 (1.3112)
21-day dosing schedule: Week 30	2.888 (0.8676)
28-day dosing schedule: Week 48	2.183 (1.1944)
21-day dosing schedule: Week 48	2.606 (0.8433)

9. Secondary Outcome

Title	Incidence Rate of Any Infection Other Than Acute Serious Bacterial Infections
Description	Incidence rate was defined as the mean number of any infection other than acute serious bacterial infections (bacterial pneumonia, bacteraemia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) per participant-year. Incidence rate of any infection other than acute bacterial serious infections collected by the participant/participants parent(s)/legal guardian(s) in the participant diary or during clinic visit was reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
21-day dosing schedule	4.2 (2.05)
28-day dosing schedule	1.6 (1.25)

10. Secondary Outcome

Title	Duration of Any Infection Other Than Acute Serious Bacterial Infections
Description	Duration of any infection other than serious acute bacterial infections (in days) was calculated as date of stop of infection - date of start of infection + 1. Duration of any infection other than serious acute bacterial infections collected by the by the participant/participants parent(s)/legal guardian(s) in the participant diary or during clinic visit was reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
21-day dosing schedule	42.9 (66.66)
28-day dosing schedule	25.3 (52.14)

11. Secondary Outcome

Title	Incidence Rate of Fever Episodes
Description	Incidence rate was defined as the mean number of fever episodes per participant-year. Incidence rate of fever episodes collected by the participant/participant's parent(s)/legal guardian(s) in the participant diary or during clinic visit were reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
21-day dosing schedule	0.0 (0.0)
28-day dosing schedule	0.2 (0.42)

12. Secondary Outcome

Title	Duration of Fever Episodes in Participants
Description	Duration of fever episodes in participants was reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who had fever episodes and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	7
28-day dosing schedule	3.0 (2.24)

13. Secondary Outcome

Title	Duration of Overall Participants Hospitalization
Description	Duration of overall participants hospitalization was reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study. Here, "Overall Number of Participants Analyzed" signifies those participants who were hospitalized and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	4
21-day dosing schedule	6.0
28-day dosing schedule	3.3 (1.53)

14. Secondary Outcome

Title	Duration of Participants Hospitalization Due to Infection
Description	Duration of participants hospitalization due to infection was reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who were hospitalized due to infection.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	0

15. Secondary Outcome

Title	Incidence Rate of Antibiotics Episodes for Treatment of Any Kind of Infections
Description	Incidence rate was defined as the mean number of antibiotics episodes per participant year. Incidence rate of participants on antibiotics for treatment of any kind of infections was reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
21-day dosing schedule	3.9 (1.98)
28-day dosing schedule	2.2 (1.49)

16. Secondary Outcome

Title	Duration of Participants on Antibiotics for Treatment of Any Kind of Infection
Description	Duration of participants on antibiotics for treatment of any kind of infection was reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who took antibiotics to treat infections and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	39
21-day dosing schedule	13.1 (5.72)
28-day dosing schedule	13.3 (35.86)

17. Secondary Outcome

Title	Duration of Missed School/Work/Other Major Activities Due to Infections
Description	Duration of missed school/work/other major activities due to infections was reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who had missed school/work/other major activities due to infections and, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	9
21-day dosing schedule	25.3 (25.11)
28-day dosing schedule	4.7 (2.73)

18. Secondary Outcome

Title	Pediatric Quality of Life Inventory (PedsQL) Score
Description	23-item PedsQL generic core scales was a modular approach to measure health-related Quality of Life (QoL) in healthy children, adolescents and those with acute and chronic health conditions. The total scale score (23 items) consisted of Physical Health Summary Score (8 items) and Psychosocial Health SummaryScore (15 items). Physical health summary included Physical Functioning (8 items) and Psychosocial health summary score included Emotional Functioning (5 items), Social Functioning (5 items) and School Functioning (5 items). Items were scored on a 5 point Likert-type response scale: 0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; and 4=almost always a problem). Once scored, items were reverse scored and linearly transformed to a 0-100 scale, where higher scores indicated better QoL. The overall range for total PedsQL score (23 items) was 0 to 100, with higher score indicated better QoL. Data for 18-25 years and >25 years age group was reported.
Time Frame	Baseline, Week 24 (21-day dosing schedule and 28-day dosing schedule), Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

The FAS included all participants who received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
Baseline (18 to 25 years)	87.5 (16.14)
21-day dosing schedule: Week 24 (18 to 25 years)	68.5
21-day dosing schedule: Week 51 (18 to 25 years)	58.7
28-day dosing schedule: Week 24 (18 to 25 years)	100.0
28-day dosing schedule: Week 52 (18 to 25 years)	100.0
Baseline (> 25 years)	76.2 (16.53)
21-day dosing schedule: Week 24 (> 25 years)	65.1 (15.92)
21-day dosing schedule: Week 51 (> 25 years)	70.3 (18.93)
28-day dosing schedule: Week 24 (> 25 years)	78.3 (17.02)
28-day dosing schedule: Week 52 (> 25 years)	77.8 (18.42)

19. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Description	An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAE was defined as an AE with an onset that occurs after receiving study drug. Any TEAE included participants with both serious and non-serious TEAEs.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

The SAF included all participants who had received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
Participants with TEAEs: 21-day dosing schedule:	8 17%
Participants with TEAEs: 28-day dosing schedule	38 80.9%
Participants with Serious TEAEs: 21-day dosing schedule	1 2.1%
Participants with Serious TEAEs: 28-day dosing schedule	3 6.4%

20. Secondary Outcome

Title	Number of TEAEs and Serious TEAEs
Description	An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. A SAE was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. A TEAE was defined as an AE with an onset that occurs after receiving study drug. Number of TEAEs and Serious TEAEs were reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

The SAF included all participants who had received at least 1 dose of study medication. "Overall Number of Participants Analyzed" signifies those participants who had TEAEs and "Number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	46
TEAEs: 21-day dosing schedule	79
TEAEs: 28-day dosing schedule	324
Serious TEAEs: 21-day dosing schedule	1
Serious TEAEs: 28-day dosing schedule	4

21. Secondary Outcome

Title	Number of Drug Related Infusion Adverse Events (AEs)
Description	An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Number of drug related infusion AEs were reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

The SAF included all participants who have received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who had drug related infusion AEs and "Number Anlyazed" signifies those who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	19
21-day dosing schedule	3
28-day dosing schedule	60

22. Secondary Outcome

Title	Percentage of Participants Who Experienced at Least One Drug Related Infusion Adverse Events (AEs)
Description	Percentage of participants who experienced at least one drug related infusion AEs were reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

The SAF included all participants who have received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
21-day dosing schedule	25.0 53.2%
28-day dosing schedule	43.6 92.8%

23. Secondary Outcome

Title	Number of Infusions With Decreased Infusion Rate Due to Adverse Events (AEs)
Description	Number of infusions with decreased infusion rate due to AEs were reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

The SAF included all participants who have received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
Measure Infusions	643
21-day dosing schedule	0
28-day dosing schedule	9

24. Secondary Outcome

Title	Number of Infusions With One or More Infusion Associated Adverse Events (AEs)
Description	The number of infusions with one or more infusion associated AEs were reported collectively for 21 and 28-day dosing schedule up to Week 52.
Time Frame	Baseline up to Week 52

Outcome Measure Data

Analysis Population Description

The SAF included all participants who have received at least 1 dose of study medication.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
Measure Infusions	643
Count of Units [Infusions]	45

25. Secondary Outcome

Title	Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Description	Vital signs included body temperature, systolic and diastolic blood pressure, heart rate and weight. The systolic and diastolic blood pressure and pulse rate was measured after the participants have in a rested at least 3 minutes in seated position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in vital signs were reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

SAF included all participants who have received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
21-day dosing schedule	0 0%
28-day dosing schedule	0 0%

26. Secondary Outcome

Title	Number of Participants With Clinically Significant Changes From Baseline in Physical Examinations
Description	Physical examination included the examination of general appearance, skin, neck, eyes, ears, nose, throat, cardiovascular assessment including rhythm, and presence of other cardiac abnormalities (for example gallops, murmurs, cardiomegaly), respiratory system, gastrointestinal system, genitourinary system and musculoskeletal system. Clinical significance was decided by the investigator. The number of participants with clinically significant changes from baseline in physical examination were reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

The SAF included all participants who have received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
21-day dosing schedule	0 0%
28-day dosing schedule	0 0%

27. Secondary Outcome

Title	Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
Description	Laboratory parameters included chemistry, hematology and urinalysis. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in laboratory parameters were reported.
Time Frame	Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Outcome Measure Data

Analysis Population Description

The SAF included all participants who have received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
Hematology: 21-day dosing schedule	3 6.4%
Hematology: 28-day dosing schedule	7 14.9%
Chemistry: 21-day dosing schedule	1 2.1%
Chemistry: 28-day dosing schedule	5 10.6%
Urinalysis: 21-day dosing schedule	2 4.3%
Urinalysis: 28-day dosing schedule	4 8.5%

28. Secondary Outcome

Title	Number of Participants With Positive Coomb's Test at Week 16 (28-day Dosing Schedule) and Week 18 (21-day Dosing Schedule)
Description	Intravascular hemolysis testing was performed by using coomb's test. The coomb's assessment was performed at a central laboratory.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)

Outcome Measure Data

Analysis Population Description

SAF included all participants who have received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies those participants with Coombs Test and "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	46
28-day dosing schedule: Week 16	14 29.8%
21-day dosing schedule: Week 18	4 8.5%

29. Secondary Outcome

Title	Number of Participants With Positive Urine Hemosiderin Test
Description	Number of participants with positive urine hemosiderin test were reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)

Outcome Measure Data

Analysis Population Description

The FAS included all participants who received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
28-day dosing schedule: Week 16	0 0%
21-day dosing schedule: Week 18	0 0%

30. Secondary Outcome

Title	Number of Participants With Abnormal Plasma-free Haemoglobin Level
Description	Number of participants with plasma-free haemoglobin level more than or equal to (>=) 69 milligrams per deciliter (mg/dL) were consisdered as abormal and were reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)

Outcome Measure Data

Analysis Population Description

The FAS included all participants who received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
28-day dosing schedule: Week 16	10 21.3%
21-day dosing schedule : Week 18	2 4.3%

31. Secondary Outcome

Title	Number of Participants With Abnormal Serum Haptoglobin Level
Description	Number of participants with abnormal serum haptoglobin level were reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)

Outcome Measure Data

Analysis Population Description

The FAS included all participants who received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	47
28-day dosing schedule: Week 16	10 21.3%
21-day dosing schedule: Week 18	0 0%

32. Secondary Outcome

Title	Maximum Observed Serum Concentration (Cmax) of Total Immunoglobulin G (IgG)
Description	Cmax was obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule)/7th infusion (21-day infusion schedule). This set included all participants following principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
Baseline corrected: 28-day dosing schedule: Week 16	13.018 (4.1559)
Baseline corrected: 21-day dosing schedule: Week 18	15.216 (1.8465)
Baseline uncorrected: 28-day dosing schedule: Week 16	22.956 (4.6474)
Baseline uncorrected: 21-day dosing schedule: Week 18	26.800 (2.8267)

33. Secondary Outcome

Title	Elimination Half-Life (t1/2) of Total IgG
Description	t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	22
Baseline corrected: 28-day dosing schedule: Week 16	176.52 (77.587)
Baseline corrected: 21-day dosing schedule: Week 18	107.13 (45.622)
Baseline uncorrected: 28-day dosing schedule: Week 16	883.61 (262.985)
Baseline uncorrected: 21-day dosing schedule: Week 18	587.48 (53.533)

34. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Total IgG
Description	Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. Both baseline corrected and un-corrected data was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
Baseline corrected: 28-day dosing schedule: Week 16	2397.661 (672.214)
Baseline corrected: 21-day dosing schedule: Week 18	2365.571 (557.8165)
Baseline uncorrected: 28-day dosing schedule: Week 16	8949.0692 (1852.98072)
Baseline uncorrected: 21-day dosing schedule: Week 18	8063.7174 (788.56020)

35. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total IgG
Description	AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	22
Baseline corrected: 28-day dosing schedule: Week 16	2710.991 (733.1555)
Baseline corrected: 21-day dosing schedule: Week 18	2435.562 (471.842)
Baseline uncorrected: 28-day dosing schedule: Week 16	22065.3148 (5061.15798)
Baseline uncorrected: 21-day dosing schedule: Week 18	18292.68 (2869.244)

36. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Total IgG
Description	AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule. Both baseline corrected and un-corrected data was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
Baseline corrected: 28-day dosing schedule: Week 16	2501.087 (686.4844)
Baseline corrected: 21-day dosing schedule: Week 18	2548.921 (627.9922)
Baseline uncorrected: 28-day dosing schedule: Week 16	9186.8416 (1592.43062)
Baseline uncorrected: 21-day dosing schedule: Week 18	8284.2045 (789.66868)

37. Secondary Outcome

Title	Volume of Distribution (Vd) of Total IgG
Description	Vd was defined as the the theoretical volume in which the total amount of total IgG would need to be uniformly distributed to produce the desired blood concentration of a total IgG. Both baseline corrected and un-corrected data was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	22
Baseline corrected: 28-day dosing schedule: Week 16	53.2387 (11.01878)
Baseline corrected: 21-day dosing schedule: Week 18	47.558 (18.66707)
Baseline uncorrected: 28-day dosing schedule: Week 16	68.5803 (12.11020)
Baseline uncorrected: 21-day dosing schedule: Week 18	66.5105 (4.00361)

38. Secondary Outcome

Title	Steady State Clearance (CLss) of Total IgG
Description	Clearance of a total IgG was a measure of the rate at which a total IgG is metabolized or eliminated by normal biological processes. CLss of total IgG was measured in milliliters per hour per kilogram (mL/hr/kg). Both baseline corrected and un-corrected data was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	22
Baseline corrected: 28-day dosing schedule: Week 16	0.2154 (0.04391)
Baseline corrected: 21-day dosing schedule: Week 18	0.2846 (0.04115)
Baseline uncorrected: 28-day dosing schedule: Week 16	0.0578 (0.01502)
Baseline uncorrected: 21-day dosing schedule: Week 18	0.0800 (0.01254)

39. Secondary Outcome

Title	Minimum Observed Serum Concentration (Cmin) of Total IgG
Description	Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
Baseline corrected: 28-day dosing schedule: Week 16	0.00 (0.00)
Baseline corrected: 21-day dosing schedule: Week 18	0.00 (0.00)
Baseline uncorrected: 28-day dosing schedule: Week 16	10.000 (1.9926)
Baseline uncorrected: 21-day dosing schedule: Week 18	11.400 (1.4832)

40. Secondary Outcome

Title	Time to Reach the Maximum Serum Concentration (Tmax) of Total IgG
Description	Tmax was obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
Baseline corrected: 28-day dosing schedule: Week 16	0.517
Baseline corrected: 21-day dosing schedule: Week 18	0.533
Baseline uncorrected: 28-day dosing schedule: Week 16	0.517
Baseline uncorrected: 21-day dosing schedule: Week 18	0.500

41. Secondary Outcome

Title	Elimination Rate Constant (Kel) of Total IgG
Description	Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	22
Baseline corrected: 28-day dosing schedule: Week 16	0.0045 (0.00175)
Baseline corrected: 21-day dosing schedule: Week 18	0.0072 (0.00243)
Baseline uncorrected: 28-day dosing schedule: Week 16	0.0009 (0.00027)
Baseline uncorrected: 21-day dosing schedule: Week 18	0.0012 (0.00011)

42. Secondary Outcome

Title	Average Concentration of Total IgG Over the Dosing Interval (Cavg)
Description	Average concentration of total IgG over the dosing interval (Cavg) was reported. Both baseline corrected and un-corrected data was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule)/7th infusion (21-day infusion schedule). This set included all participants following principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
Baseline corrected: 28-day dosing schedule: Week 16	3.7219 (1.02155)
Baseline corrected: 21-day dosing schedule: Week 18	5.0574 (1.24602)
Baseline uncorrected: 28-day dosing schedule: Week 16	13.6709 (2.36969)
Baseline uncorrected: 21-day dosing schedule: Week 18	16.4369 (1.56680)

43. Secondary Outcome

Title	Percentage Peak Trough Fluctuation of Total IgG
Description	The peak trough fluctuation within complete dosing interval at steady state of total IgG was reported. Both baseline corrected and un-corrected data was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
Baseline corrected: 28-day dosing schedule: Week 16	329.9058 (51.89226)
Baseline corrected: 21-day dosing schedule: Week 18	284.1351 (93.16774)
Baseline uncorrected: 28-day dosing schedule: Week 16	94.9186 (30.34251)
Baseline uncorrected: 21-day dosing schedule: Week 18	93.8710 (8.21036)

44. Secondary Outcome

Title	Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Tetanus Toxoid Antibodies
Description	Cmax was obtained directly from the concentration versus time curve.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
28-day dosing schedule: Week 16	6.533 (2.9955)
21-day dosing schedule: Week 18	7.400 (2.0988)

45. Secondary Outcome

Title	Elimination Half-Life (t1/2) of Antigen-Specific Tetanus Toxoid Antibodies
Description	t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	21
28-day dosing schedule: Week 16	618.97 (320.008)
21-day dosing schedule: Week 18	1097.75 (1061.343)

46. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Tetanus Toxoid Antibodies
Description	Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. The AUC0-t of antigen-specific tetanus toxoid antibodies was measured in hour*international units per milliliter (hr*IU/mL).
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
28-day dosing schedule: Week 16	2037.7497 (568.85079)
21-day dosing schedule: Week 18	1805.9758 (210.37005)

47. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Tetanus Toxoid Antibodies
Description	AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	21
28-day dosing schedule: Week 16	4171.4977 (2513.60199)
21-day dosing schedule: Week 18	10142.0162 (12855.54687)

48. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Tetanus Toxoid Antibodies
Description	AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	21
28-day dosing schedule: Week 16	1997.8829 (526.07254)
21-day dosing schedule: Week 18	1934.6533 (317.07241)

49. Secondary Outcome

Title	Volume of Distribution (Vd) of Antigen-Specific Tetanus Toxoid Antibodies
Description	Vd was defined as the the theoretical volume in which the total amount of antigen-specific tetanus toxoid antibodies would need to be uniformly distributed to produce the desired blood concentration of antigen-specific tetanus toxoid antibodies. The Vd of antigen-specific tetanus toxoid antibodies was measured in milligrams*milliliter per international unit*kilogram (mg*mL/IU*kg).
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	21
28-day dosing schedule: Week 16	263.3132 (157.80776)
21-day dosing schedule: Week 18	688.4792 (792.01235)

50. Secondary Outcome

Title	Steady State Clearance (CLss) of Antigen-Specific Tetanus Toxoid Antibodies
Description	Clearance of a antigen-specific tetanus toxoid antibodies was a measure of the rate at which a antigen-specific tetanus toxoid antibodies are metabolized or eliminated by normal biological processes. The CLss of antigen-specific tetanus toxoid antibodies was reported. The CLss of antigen-specific tetanus toxoid antibodies was measured in milligrams*milliliter per hour*international unit*kilogram (mg*mL/hr*IU*kg).
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	21
28-day dosing schedule: Week 16	0.2741 (0.06916)
21-day dosing schedule: Week 18	0.3724 (0.05201)

51. Secondary Outcome

Title	Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Tetanus Toxoid Antibodies
Description	Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
28-day dosing schedule: Week 16	1.833 (0.5531)
21-day dosing schedule: Week 18	2.240 (0.4827)

52. Secondary Outcome

Title	Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Tetanus Toxoid Antibodies
Description	Tmax was obtained directly from the concentration versus time curve.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
28-day dosing schedule: Week 16	2.000
21-day dosing schedule: Week 18	70.450

53. Secondary Outcome

Title	Elimination Rate Constant (Kel) of Antigen-Specific Tetanus Toxoid Antibodies
Description	Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	11
28-day dosing schedule: Week 16	0.0014 (0.00062)
21-day dosing schedule: Week 18	0.0011 (0.00065)

54. Secondary Outcome

Title	Average Concentration of Antigen-Specific Tetanus Toxoid Antibodies Over the Dosing Interval (Cavg)
Description	Average concentration of antigen-specific tetanus toxoid antibodies over the dosing interval (Cavg) was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	21
28-day dosing schedule: Week 16	2.9730 (0.78285)
21-day dosing schedule: Week 18	3.8386 (0.62911)

55. Secondary Outcome

Title	Percentage Peak Trough Fluctuation of Antigen-Specific Tetanus Toxoid Antibodies
Description	The peak trough fluctuation within complete dosing interval at steady state of antigen-specific tetanus toxoid antibodies was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	21
28-day dosing schedule: Week 16	154.7237 (63.56527)
21-day dosing schedule: Week 18	145.9127 (55.92179)

56. Secondary Outcome

Title	Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Description	Cmax was obtained directly from the concentration versus time curve.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	22
28-day dosing schedule: Week 16	6.812 (2.0561)
21-day dosing schedule: Week 18	8.040 (1.0691)

57. Secondary Outcome

Title	Elimination Half-Life (t1/2) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Description	t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time pointsas per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	22
28-day dosing schedule: Week 16	732.01 (485.238)
21-day dosing schedule: Week 18	390.65 (58.791)

58. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Description	Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. AUC0-t of antigen-specific haemophilus influenza Type B Antibodies was measured in hour*microgram per milliliter (hr*mcg/mL).
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	22
28-day dosing schedule: Week 16	2355.9789 (1042.51995)
21-day dosing schedule: Week 18	2220.0439 (553.77654)

59. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Description	AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	20
28-day dosing schedule: Week 16	5087.4141 (3563.09258)
21-day dosing schedule: Week 18	4223.1698 (493.35835)

60. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Description	AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	5
28-day dosing schedule: Week 16	2364.5034 (1040.6978)
21-day dosing schedule: Week 18	2467.4550 (569.74079)

61. Secondary Outcome

Title	Volume of Distribution (Vd) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Description	Vd was defined as the the theoretical volume in which the total amount of antigen-specific haemophilus influenza type B antibodies would need to be uniformly distributed to produce the desired blood concentration of a antigen-specific haemophilus influenza type B antibodies.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	20
28-day dosing schedule: Week 16	245966.4231 (160457.69395)
21-day dosing schedule: Week 18	182273.0408 (88143.84190)

62. Secondary Outcome

Title	Steady State Clearance (CLss) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Description	Clearance of antigen-specific haemophilus influenza type B antibodies was a measure of the rate at which antigen-specific haemophilus influenza type B antibodies were metabolized or eliminated by normal biological processes. CLss of antigen-specific haemophilus influenza type B antibodies was measured in milliliter per hour per kilogram (mL/hr/kg).
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	20
28-day dosing schedule: Week 16	253.5539 (75.88763)
21-day dosing schedule: Week 18	299.5030 (100.44087)

63. Secondary Outcome

Title	Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Description	Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	22
28-day dosing schedule: Week 16	2.159 (1.3440)
21-day dosing schedule: Week 18	2.260 (0.6427)

64. Secondary Outcome

Title	Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Description	Tmax was obtained directly from the concentration versus time curve.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	22
28-day dosing schedule: Week 16	0.500
21-day dosing schedule: Week 18	72.167

65. Secondary Outcome

Title	Elimination Rate Constant (Kel) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Description	Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	20
28-day dosing schedule: Week 16	0.0014 (0.00079)
21-day dosing schedule: Week 18	0.0018 (0.00028)

66. Secondary Outcome

Title	Average Concentration of Antigen-Specific Haemophilus Influenza Type B Antibodies Over the Dosing Interval (Cavg)
Description	Average concentration of antigen-specific haemophilus influenza type B antibodies over the dosing interval (Cavg) was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	20
28-day dosing schedule: Week 16	3.5186 (1.54866)
21-day dosing schedule: Week 18	4.8957 (1.13044)

67. Secondary Outcome

Title	Percentage Peak Trough Fluctuation of Antigen-Specific Haemophilus Influenza Type B Antibodies
Description	The peak trough fluctuation within complete dosing interval at steady state of antigen-specific haemophilus influenza type B antibodies was reported.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	20
28-day dosing schedule: Week 16	147.4372 (72.11547)
21-day dosing schedule: Week 18	126.0687 (35.29156)

68. Secondary Outcome

Title	Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Description	Cmax was obtained directly from the concentration versus time curve. The Cmax for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8, serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule)/7th infusion (21-day infusion schedule). This set included all participants following principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
28-day dosing schedule: Week 16: Serotype 1	3.478 (2.7623)
28-day dosing schedule: Week 16: Serotype 12	1.256 (1.2458)
28-day dosing schedule: Week 16: Serotype 14	20.378 (46.3772)
28-day dosing schedule: Week 16: Serotype 17	4.350 (5.6783)
28-day dosing schedule: Week 16: Serotype 19	7.767 (8.5255)
28-day dosing schedule: Week 16: Serotype 2	3.822 (1.2758)
28-day dosing schedule: Week 16: Serotype 20	4.728 (3.0665)
28-day dosing schedule: Week 16: Serotype 22	2.050 (1.3382)
28-day dosing schedule: Week 16: Serotype 23	3.039 (3.3482)
28-day dosing schedule: Week 16: Serotype 26	2.433 (1.3569)
28-day dosing schedule: Week 16: Serotype 3	2.933 (1.6150)
28-day dosing schedule: Week 16: Serotype 4	0.685 (0.2410)
28-day dosing schedule: Week 16: Serotype 34	2.472 (0.9940)
28-day dosing schedule: Week 16: Serotype 43	2.572 (1.1108)
28-day dosing schedule: Week 16: Serotype 5	5.217 (4.0965)
28-day dosing schedule: Week 16: Serotype 51	3.611 (1.3788)
28-day dosing schedule: Week 16: Serotype 54	4.806 (2.0783)
28-day dosing schedule: Week 16: Serotype 56	5.778 (11.7004)
28-day dosing schedule: Week 16: Serotype 57	12.511 (21.4792)
28-day dosing schedule: Week 16: Serotype 68	1.806 (0.8033)
28-day dosing schedule: Week 16: Serotype 70	3.228 (1.6080)
28-day dosing schedule: Week 16: Serotype 8	3.683 (2.6600)
28-day dosing schedule: Week 16: Serotype 9	1.583 (0.7148)
21-day dosing schedule: Week 18: Serotype 1	8.440 (8.3182)
21-day dosing schedule: Week 18: Serotype 12	1.140 (0.1673)
21-day dosing schedule: Week 18: Serotype 14	11.280 (3.5053)
21-day dosing schedule: Week 18: Serotype 17	5.860 (4.0930)
21-day dosing schedule: Week 18: Serotype 19	6.440 (1.0691)
21-day dosing schedule: Week 18: Serotype 2	6.180 (4.6370)
21-day dosing schedule: Week 18: Serotype 20	5.580 (1.8754)
21-day dosing schedule: Week 18: Serotype 22	4.420 (5.4422)
21-day dosing schedule: Week 18: Serotype 23	2.360 (0.8620)
21-day dosing schedule: Week 18: Serotype 26	3.340 (2.5373)
21-day dosing schedule: Week 18: Serotype 3	9.720 (12.7874)
21-day dosing schedule: Week 18: Serotype 34	5.060 (6.2843)
21-day dosing schedule: Week 18: Serotype 4	0.980 (0.6301)
21-day dosing schedule: Week 18: Serotype 43	2.660 (0.7403)
21-day dosing schedule: Week 18: Serotype 5	10.160 (12.4969)
21-day dosing schedule: Week 18: Serotype 51	11.700 (14.2886)
21-day dosing schedule: Week 18: Serotype 54	9.820 (10.6338)
21-day dosing schedule: Week 18: Serotype 56	13.300 (19.3380)
21-day dosing schedule: Week 18: Serotype 57	5.825 (0.9878)
21-day dosing schedule: Week 18: Serotype 68	2.460 (1.7009)
21-day dosing schedule: Week 18: Serotype 70	6.260 (7.0741)
21-day dosing schedule: Week 18: Serotype 8	6.120 (4.5510)
21-day dosing schedule: Week 18: Serotype 9	1.980 (0.7294)

69. Secondary Outcome

Title	Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Description	t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The t1/2 for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	13
28-day dosing schedule: Week 16: Serotype 1	533.06 (279.860)
28-day dosing schedule: Week 16: Serotype 12	415.27 (104.179)
28-day dosing schedule: Week 16: Serotype 14	737.33 (293.005)
28-day dosing schedule: Week 16: Serotype 17	568.11 (184.079)
28-day dosing schedule: Week 16: Serotype 19	794.76 (365.625)
28-day dosing schedule: Week 16: Serotype 2	943.63 (597.812)
28-day dosing schedule: Week 16: Serotype 20	977.87 (511.568)
28-day dosing schedule: Week 16: Serotype 22	574.22 (258.366)
28-day dosing schedule: Week 16: Serotype 23	837.29 (476.321)
28-day dosing schedule: Week 16: Serotype 26	638.60 (285.966)
28-day dosing schedule: Week 16: Serotype 3	626.69 (275.200)
28-day dosing schedule: Week 16: Serotype 34	680.14 (400.291)
28-day dosing schedule: Week 16: Serotype 4	522.15 (39.466)
28-day dosing schedule: Week 16: Serotype 43	573.32 (191.776)
28-day dosing schedule: Week 16: Serotype 5	632.03 (220.955)
28-day dosing schedule: Week 16: Serotype 51	794.63 (474.015)
28-day dosing schedule: Week 16: Serotype 54	1184.97 (1088.054)
28-day dosing schedule: Week 16: Serotype 56	527.75 (144.729)
28-day dosing schedule: Week 16: Serotype 57	1346.21 (1574.359)
28-day dosing schedule: Week 16: Serotype 68	688.31 (354.982)
28-day dosing schedule: Week 16: Serotype 70	709.41 (282.061)
28-day dosing schedule: Week 16: Serotype 8	562.30 (138.178)
28-day dosing schedule: Week 16: Serotype 9	555.66 (274.555)
21-day dosing schedule: Week 18: Serotype 1	813.74
21-day dosing schedule: Week 18: Serotype 12	498.21 (105.271)
21-day dosing schedule: Week 18: Serotype 14	1467.24
21-day dosing schedule: Week 18: Serotype 17	1161.62 (409.606)
21-day dosing schedule: Week 18: Serotype 19	839.73 (867.812)
21-day dosing schedule: Week 18: Serotype 2	860.60
21-day dosing schedule: Week 18: Serotype 20	779.88
21-day dosing schedule: Week 18: Serotype 22	966.61 (104.462)
21-day dosing schedule: Week 18: Serotype 23	805.76 (155.609)
21-day dosing schedule: Week 18: Serotype 26	900.44
21-day dosing schedule: Week 18: Serotype 3	292.95
21-day dosing schedule: Week 18: Serotype 34	820.04 (92.314)
21-day dosing schedule: Week 18: Serotype 4	638.35 (549.756)
21-day dosing schedule: Week 18: Serotype 43	295.34 (120.334)
21-day dosing schedule: Week 18: Serotype 5	825.99
21-day dosing schedule: Week 18: Serotype 51	813.32
21-day dosing schedule: Week 18: Serotype 54	754.20
21-day dosing schedule: Week 18: Serotype 56	931.50
21-day dosing schedule: Week 18: Serotype 68	259.63
21-day dosing schedule: Week 18: Serotype 70	1437.71 (1083.055)
21-day dosing schedule: Week 18: Serotype 8	616.54
21-day dosing schedule: Week 18: Serotype 9	890.30

70. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Description	Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. AUC0-t of antigen-pneumococcal capsular polysaccharide was measured in hour*microgram per milliliter (hr*mcg/mL). The AUC0-t for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
28-day dosing schedule: Week 16: Serotype 1	1267.2703 (1231.86109)
28-day dosing schedule: Week 16: Serotype 12	481.8080 (615.13837)
28-day dosing schedule: Week 16: Serotype 14	7680.6757 (17443.37339)
28-day dosing schedule: Week 16: Serotype 17	1707.2987 (2326.27590)
28-day dosing schedule: Week 16: Serotype 19	3264.5178 (4922.67289)
28-day dosing schedule: Week 16: Serotype 2	1462.1037 (491.94211)
28-day dosing schedule: Week 16: Serotype 20	1776.5915 (1472.71297)
28-day dosing schedule: Week 16: Serotype 22	767.3831 (752.08067)
28-day dosing schedule: Week 16: Serotype 23	1206.7604 (1547.47617)
28-day dosing schedule: Week 16: Serotype 26	929.6216 (696.05624)
28-day dosing schedule: Week 16: Serotype 3	940.1352 (397.58653)
28-day dosing schedule: Week 16: Serotype 34	916.8877 (339.74807)
28-day dosing schedule: Week 16: Serotype 4	245.8296 (89.81281)
28-day dosing schedule: Week 16: Serotype 43	901.9934 (415.28147)
28-day dosing schedule: Week 16: Serotype 5	1882.0174 (1606.54653)
28-day dosing schedule: Week 16: Serotype 51	1313.1756 (285.57756)
28-day dosing schedule: Week 16: Serotype 54	1659.0010 (487.17054)
28-day dosing schedule: Week 16: Serotype 56	2361.1009 (5435.67901)
28-day dosing schedule: Week 16: Serotype 57	5140.5242 (10426.05050)
28-day dosing schedule: Week 16: Serotype 68	637.6826 (180.23219)
28-day dosing schedule: Week 16: Serotype 70	1239.3842 (746.05163)
28-day dosing schedule: Week 16: Serotype 8	1396.1732 (1343.80361)
28-day dosing schedule: Week 16: Serotype 9	545.3315 (201.37388)
21-day dosing schedule: Week 18: Serotype 1	3361.3444 (3529.24121)
21-day dosing schedule: Week 18: Serotype 12	364.7574 (66.07380)
21-day dosing schedule: Week 18: Serotype 14	4026.2582 (1827.76472)
21-day dosing schedule: Week 18: Serotype 17	2327.4433 (1869.77732)
21-day dosing schedule: Week 18: Serotype 19	2139.8818 (546.99394)
21-day dosing schedule: Week 18: Serotype 2	2388.1819 (2054.90148)
21-day dosing schedule: Week 18: Serotype 20	2088.0431 (956.15600)
21-day dosing schedule: Week 18: Serotype 22	1728.1721 (2363.07921)
21-day dosing schedule: Week 18: Serotype 23	826.4154 (390.75602)
21-day dosing schedule: Week 18: Serotype 26	1199.7678 (1115.65007)
21-day dosing schedule: Week 18: Serotype 3	3834.6179 (5425.47048)
21-day dosing schedule: Week 18: Serotype 34	2095.6088 (2982.98719)
21-day dosing schedule: Week 18: Serotype 4	363.5605 (289.99268)
21-day dosing schedule: Week 18: Serotype 43	919.1971 (290.08829)
21-day dosing schedule: Week 18: Serotype 5	4050.8597 (5582.10279)
21-day dosing schedule: Week 18: Serotype 51	4775.1477 (6034.17097)
21-day dosing schedule: Week 18: Serotype 54	3849.0042 (4696.54103)
21-day dosing schedule: Week 18: Serotype 56	5069.9328 (7483.01937)
21-day dosing schedule: Week 18: Serotype 57	1946.7526 (134.44174)
21-day dosing schedule: Week 18: Serotype 68	900.2735 (757.57732)
21-day dosing schedule: Week 18: Serotype 70	2385.0419 (3013.20369)
21-day dosing schedule: Week 18: Serotype 8	2555.3317 (2162.87976)
21-day dosing schedule: Week 18: Serotype 9	707.9849 (310.25117)

71. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Description	AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The AUC0-inf for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20 serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	3
28-day dosing schedule: Week 16: Serotype 1	835.7493
28-day dosing schedule: Week 16: Serotype 17	815.5984
28-day dosing schedule: Week 16: Serotype 22	706.0824 (101.30543)
28-day dosing schedule: Week 16: Serotype 3	753.3039
28-day dosing schedule: Week 16: Serotype 56	871.0663
28-day dosing schedule: Week 16: Serotype 9	494.5129
21-day dosing schedule: Week 18: Serotype 43	1072.8342

72. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Description	AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule. The AUCtau for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	21
28-day dosing schedule: Week 16: Serotype 1	1295.2208 (1284.98717)
28-day dosing schedule: Week 16: Serotype 12	496.5246 (652.01919)
28-day dosing schedule: Week 16: Serotype 14	7938.1617 (18005.53693)
28-day dosing schedule: Week 16: Serotype 17	1128.6509 (606.69308)
28-day dosing schedule: Week 16: Serotype 19	2051.7286 (805.43957)
28-day dosing schedule: Week 16: Serotype 2	1437.7169 (551.52102)
28-day dosing schedule: Week 16: Serotype 20	1738.1297 (1558.89268)
28-day dosing schedule: Week 16: Serotype 22	759.1847 (785.00558)
28-day dosing schedule: Week 16: Serotype 23	1221.7947 (1608.36169)
28-day dosing schedule: Week 16: Serotype 26	929.6706 (739.10055)
28-day dosing schedule: Week 16: Serotype 3	902.9745 (415.50944)
28-day dosing schedule: Week 16: Serotype 34	879.5261 (347.31703)
28-day dosing schedule: Week 16: Serotype 4	241.3102 (93.08585)
28-day dosing schedule: Week 16: Serotype 43	934.7032 (507.01946)
28-day dosing schedule: Week 16: Serotype 5	1525.6893 (617.53144)
28-day dosing schedule: Week 16: Serotype 51	1327.8807 (304.68999)
28-day dosing schedule: Week 16: Serotype 54	1665.6043 (473.20463)
28-day dosing schedule: Week 16: Serotype 56	2456.3187 (5608.60157)
28-day dosing schedule: Week 16: Serotype 57	5157.6297 (10068.88936)
28-day dosing schedule: Week 16: Serotype 68	646.0577 (303.83828)
28-day dosing schedule: Week 16: Serotype 70	1242.0569 (791.72945)
28-day dosing schedule: Week 16: Serotype 8	1112.3875 (364.77366)
28-day dosing schedule: Week 16: Serotype 9	549.2854 (205.21945)
21-day dosing schedule: Week 18: Serotype 1	3427.1894 (4395.22135)
21-day dosing schedule: Week 18: Serotype 12	340.6625 (40.16239)
21-day dosing schedule: Week 18: Serotype 14	4203.7328 (2074.59529)
21-day dosing schedule: Week 18: Serotype 17	2120.4069 (1774.61729)
21-day dosing schedule: Week 18: Serotype 19	2588.0431 (884.21458)
21-day dosing schedule: Week 18: Serotype 2	1995.4796 (1312.64625)
21-day dosing schedule: Week 18: Serotype 20	2571.9984 (1782.65587)
21-day dosing schedule: Week 18: Serotype 22	860.7046 (377.70459)
21-day dosing schedule: Week 18: Serotype 23	1074.8702 (591.84867)
21-day dosing schedule: Week 18: Serotype 26	1640.1471 (1585.98684)
21-day dosing schedule: Week 18: Serotype 3	6340.4080 (9208.98601)
21-day dosing schedule: Week 18: Serotype 34	871.0315 (46.94825)
21-day dosing schedule: Week 18: Serotype 4	464.1417 (438.74819)
21-day dosing schedule: Week 18: Serotype 43	971.2482 (311.33350)
21-day dosing schedule: Week 18: Serotype 5	1536.7299 (239.98044)
21-day dosing schedule: Week 18: Serotype 51	5984.7197 (8063.82766)
21-day dosing schedule: Week 18: Serotype 54	4422.4410 (5245.59189)
21-day dosing schedule: Week 18: Serotype 56	6780.9969 (9967.85603)
21-day dosing schedule: Week 18: Serotype 57	2280.6541 (245.58661)
21-day dosing schedule: Week 18: Serotype 68	1209.1992 (1169.34365)
21-day dosing schedule: Week 18: Serotype 70	1136.7545 (243.27839)
21-day dosing schedule: Week 18: Serotype 8	2145.6232 (1950.12455)
21-day dosing schedule: Week 18: Serotype 9	764.0375 (331.36438)

73. Secondary Outcome

Title	Volume of Distribution (Vd) of of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Description	Vd was defined as the the theoretical volume in which the total amount of anti-pneumococcal capsular polysaccharide would need to be uniformly distributed to produce the desired blood concentration of a anti-pneumococcal capsular polysaccharide. The Vd for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	3
28-day dosing schedule: Week 16: Serotype 1	329057.3200
28-day dosing schedule: Week 16: Serotype 17	341197.1700
28-day dosing schedule: Week 16: Serotype 22	231539.8050 (104298.38458)
28-day dosing schedule: Week 16: Serotype 3	226738.9500
28-day dosing schedule: Week 16: Serotype 56	342896.0600
28-day dosing schedule: Week 16: Serotype 9	526016.9000
21-day dosing schedule: Week 18: Serotype 43	283171.4700

74. Secondary Outcome

Title	Steady State Clearance (CLss) of Anti-pneumococcal Capsular Polysaccharide Antibodies (Overall SP Serotypes)
Description	Clearance of a anti-pneumococcal capsular polysaccharide antibodies was a measure of the rate at which a anti-pneumococcal capsular polysaccharide antibodies are metabolized or eliminated by normal biological processes. The CLss of anti-pneumococcal capsular polysaccharide antibodies was reported. The CLss of anti-pneumococcal capsular polysaccharide antibodies was measured in milligrams*milliliter per hour*international unit*kilogram (mg*mL/hr*IU*kg). The CLss for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	3
28-day dosing schedule: Week 16: Serotype 1	860.4600
28-day dosing schedule: Week 16: Serotype 17	862.3000
28-day dosing schedule: Week 16: Serotype 22	604.0850 (190.31779)
28-day dosing schedule: Week 16: Serotype 3	705.5700
28-day dosing schedule: Week 16: Serotype 56	854.8300
28-day dosing schedule: Week 16: Serotype 9	1441.7300
21-day dosing schedule: Week 18: Serotype 43	849.0400

75. Secondary Outcome

Title	Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Description	Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve. The Cmin for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
28-day dosing schedule: Week 16: Serotype 1	1.167 (0.7577)
28-day dosing schedule: Week 16: Serotype 12	0.528 (0.8259)
28-day dosing schedule: Week 16: Serotype 14	8.361 (19.9012)
28-day dosing schedule: Week 16: Serotype 17	2.328 (4.4311)
28-day dosing schedule: Week 16: Serotype 19	3.783 (6.2568)
28-day dosing schedule: Week 16: Serotype 2	1.656 (0.8487)
28-day dosing schedule: Week 16: Serotype 20	1.689 (0.7522)
28-day dosing schedule: Week 16: Serotype 22	0.817 (1.0257)
28-day dosing schedule: Week 16: Serotype 23	1.228 (1.8588)
28-day dosing schedule: Week 16: Serotype 26	0.978 (0.6804)
28-day dosing schedule: Week 16: Serotype 3	0.950 (0.5924)
28-day dosing schedule: Week 16: Serotype 34	1.033 (0.6903)
28-day dosing schedule: Week 16: Serotype 4	0.277 (0.1235)
28-day dosing schedule: Week 16: Serotype 43	0.983 (0.6600)
28-day dosing schedule: Week 16: Serotype 5	2.306 (3.2598)
28-day dosing schedule: Week 16: Serotype 51	1.406 (0.4771)
28-day dosing schedule: Week 16: Serotype 54	1.733 (0.6598)
28-day dosing schedule: Week 16: Serotype 56	2.750 (6.7280)
28-day dosing schedule: Week 16: Serotype 57	5.422 (10.7795)
28-day dosing schedule: Week 16: Serotype 68	0.728 (0.4390)
28-day dosing schedule: Week 16: Serotype 70	1.350 (0.9931)
28-day dosing schedule: Week 16: Serotype 8	1.294 (0.6476)
28-day dosing schedule: Week 16: Serotype 9	0.517 (0.2550)
21-day dosing schedule: Week 18 : Serotype 1	5.400 (6.4211)
21-day dosing schedule: Week 18 : Serotype 12	0.440 (0.1817)
21-day dosing schedule: Week 18 : Serotype 14	5.880 (4.0084)
21-day dosing schedule: Week 18 : Serotype 17	3.700 (3.3978)
21-day dosing schedule: Week 18 : Serotype 19	2.940 (1.3107)
21-day dosing schedule: Week 18 : Serotype 2	3.600 (3.6159)
21-day dosing schedule: Week 18 : Serotype 20	3.120 (1.8992)
21-day dosing schedule: Week 18 : Serotype 22	2.520 (3.6486)
21-day dosing schedule: Week 18 : Serotype 23	1.200 (0.8660)
21-day dosing schedule: Week 18: Serotype 26	1.740 (1.9191)
21-day dosing schedule: Week 18: Serotype 3	5.920 (8.6126)
21-day dosing schedule: Week 18: Serotype 34	3.220 (5.0226)
21-day dosing schedule: Week 18: Serotype 4	0.520 (0.5630)
21-day dosing schedule: Week 18: Serotype 43	1.300 (0.8031)
21-day dosing schedule: Week 18: Serotype 5	6.240 (9.6619)
21-day dosing schedule: Week 18: Serotype 51	7.620 (10.4406)
21-day dosing schedule: Week 18: Serotype 54	5.980 (8.1515)
21-day dosing schedule: Week 18: Serotype 56	7.820 (12.0038)
21-day dosing schedule: Week 18: Serotype 57	2.375 (0.5909)
21-day dosing schedule: Week 18: Serotype 68	1.400 (1.5700)
21-day dosing schedule: Week 18: Serotype 70	3.920 (5.6971)
21-day dosing schedule: Week 18: Serotype 8	4.260 (4.2846)
21-day dosing schedule: Week 18: Serotype 9	1.040 (0.6804)

76. Secondary Outcome

Title	Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Description	Tmax was obtained directly from the concentration versus time curve. The Tmax for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	23
28-day dosing schedule: Week 16: Serotype 1	0.542
28-day dosing schedule: Week 16: Serotype 12	0.517
28-day dosing schedule: Week 16: Serotype 14	1.417
28-day dosing schedule: Week 16: Serotype 17	1.992
28-day dosing schedule: Week 16: Serotype 19	0.642
28-day dosing schedule: Week 16: Serotype 2	1.458
28-day dosing schedule: Week 16: Serotype 22	0.500
28-day dosing schedule: Week 16: Serotype 23	0.642
28-day dosing schedule: Week 16: Serotype 26	0.642
28-day dosing schedule: Week 16: Serotype 3	0.517
28-day dosing schedule: Week 16: Serotype 34	1.758
28-day dosing schedule: Week 16: Serotype 4	0.500
28-day dosing schedule: Week 16: Serotype 43	1.750
28-day dosing schedule: Week 16: Serotype 5	0.642
28-day dosing schedule: Week 16: Serotype 51	0.650
28-day dosing schedule: Week 16: Serotype 54	0.642
28-day dosing schedule: Week 16: Serotype 56	1.633
28-day dosing schedule: Week 16: Serotype 57	0.642
28-day dosing schedule: Week 16: Serotype 68	0.650
28-day dosing schedule: Week 16: Serotype 70	0.500
28-day dosing schedule: Week 16: Serotype 8	0.542
28-day dosing schedule: Week 16: Serotype 9	0.500
21-day dosing schedule: Week 18 Serotype 1	71.250
21-day dosing schedule: Week 18 Serotype 12	1.783
21-day dosing schedule: Week 18 Serotype 14	70.450
21-day dosing schedule: Week 18: Serotype 17	71.250
21-day dosing schedule: Week 18: Serotype 19	1.967
21-day dosing schedule: Week 18: Serotype 2	71.250
21-day dosing schedule: Week 18: Serotype 20	2.050
21-day dosing schedule: Week 18: Serotype 22	71.250
21-day dosing schedule: Week 18: Serotype 23	2.050
21-day dosing schedule: Week 18: Serotype 26	71.250
21-day dosing schedule: Week 18: Serotype 3	71.250
21-day dosing schedule: Week 18: Serotype 34	1.967
21-day dosing schedule: Week 18: Serotype 4	1.783
21-day dosing schedule: Week 18: Serotype 43	1.967
21-day dosing schedule: Week 18: Serotype 5	71.250
21-day dosing schedule: Week 18: Serotype 51	71.250
21-day dosing schedule: Week 18: Serotype 54	71.250
21-day dosing schedule: Week 18: Serotype 56	71.250
21-day dosing schedule: Week 18: Serotype 57	70.850
21-day dosing schedule: Week 18: Serotype 68	24.700
21-day dosing schedule: Week 18: Serotype 70	1.967
21-day dosing schedule: Week 18: Serotype 8	2.050
21-day dosing schedule: Week 18: Serotype 9	70.450

77. Secondary Outcome

Title	Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Description	Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The Kel for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20 serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	12
28-day dosing schedule: Week 16: Serotype 1	0.0016 (0.00081)
28-day dosing schedule: Week 16: Serotype 12	0.0017 (0.00037)
28-day dosing schedule: Week 16: Serotype 14	0.0011 (0.00037)
28-day dosing schedule: Week 16: Serotype 17	0.0014 (0.00069)
28-day dosing schedule: Week 16: Serotype 19	0.0010 (0.00039)
28-day dosing schedule: Week 16: Serotype 2	0.0010 (0.00054)
28-day dosing schedule: Week 16: Serotype 20	0.0009 (0.00063)
28-day dosing schedule: Week 16: Serotype 22	0.0015 (0.00082)
28-day dosing schedule: Week 16: Serotype 23	0.0010 (0.00038)
28-day dosing schedule: Week 16: Serotype 26	0.0013 (0.00057)
28-day dosing schedule: Week 16: Serotype 3	0.0014 (0.00078)
28-day dosing schedule: Week 16: Serotype 34	0.0013 (0.00068)
28-day dosing schedule: Week 16: Serotype 4	0.0013 (0.00011)
28-day dosing schedule: Week 16: Serotype 43	0.0013 (0.00041)
28-day dosing schedule: Week 16: Serotype 5	0.0012 (0.00036)
28-day dosing schedule: Week 16: Serotype 51	0.0012 (0.00072)
28-day dosing schedule: Week 16: Serotype 54	0.0009 (0.00052)
28-day dosing schedule: Week 16: Serotype 56	0.0014 (0.00053)
28-day dosing schedule: Week 16: Serotype 57	0.0010 (0.00059)
28-day dosing schedule: Week 16: Serotype 68	0.0012 (0.00051)
28-day dosing schedule: Week 16: Serotype 70	0.0011 (0.00047)
28-day dosing schedule: Week 16: Serotype 8	0.0013 (0.00043)
28-day dosing schedule: Week 16: Serotype 9	0.0015 (0.00083)
21-day dosing schedule: Week 18: Serotype 1	0.0009
21-day dosing schedule: Week 18: Serotype 12	0.0014 (0.00030)
21-day dosing schedule: Week 18: Serotype 14	0.0005
21-day dosing schedule: Week 18: Serotype 17	0.0006 (0.00022)
21-day dosing schedule: Week 18: Serotype 19	0.0018 (0.00183)
21-day dosing schedule: Week 18: Serotype 2	0.0008
21-day dosing schedule: Week 18: Serotype 20	0.0009
21-day dosing schedule: Week 18: Serotype 22	0.0007 (0.00008)
21-day dosing schedule: Week 18: Serotype 23	0.0009 (0.00017)
21-day dosing schedule: Week 18: Serotype 26	0.0008
21-day dosing schedule: Week 18: Serotype 3	0.0024
21-day dosing schedule: Week 18: Serotype 34	0.0009 (0.00010)
21-day dosing schedule: Week 18: Serotype 4	0.0016 (0.00094)
21-day dosing schedule: Week 18: Serotype 43	0.0026 (0.00104)
21-day dosing schedule: Week 18: Serotype 5	0.0008
21-day dosing schedule: Week 18: Serotype 51	0.0009
21-day dosing schedule: Week 18: Serotype 54	0.0009
21-day dosing schedule: Week 18: Serotype 56	0.0007
21-day dosing schedule: Week 18: Serotype 68	0.0027
21-day dosing schedule: Week 18: Serotype 70	0.0007 (0.00051)
21-day dosing schedule: Week 18: Serotype 8	0.0011
21-day dosing schedule: Week 18: Serotype 9	0.0008

78. Secondary Outcome

Title	Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
Description	Average concentration of anti-pneumococcal capsular polysaccharide over the dosing interval (Cavg) was reported. The Cavg for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	21
28-day dosing schedule: Week 16: Serotype 1	1.9274 (1.91218)
28-day dosing schedule: Week 16: Serotype 12	0.7389 (0.97027)
28-day dosing schedule: Week 16: Serotype 14	11.8127 (26.793)
28-day dosing schedule: Week 16: Serotype 17	1.7723 (0.86237)
28-day dosing schedule: Week 16: Serotype 19	3.2992 (1.55795)
28-day dosing schedule: Week 16: Serotype 2	2.2719 (0.84758)
28-day dosing schedule: Week 16: Serotype 20	2.6925 (2.27169)
28-day dosing schedule: Week 16: Serotype 22	1.1703 (1.14923)
28-day dosing schedule: Week 16: Serotype 23	1.8608 (2.37096)
28-day dosing schedule: Week 16: Serotype 26	1.4473 (1.09160)
28-day dosing schedule: Week 16: Serotype 3	1.4018 (0.57076)
28-day dosing schedule: Week 16: Serotype 34	1.4310 (0.67369)
28-day dosing schedule: Week 16: Serotype 4	0.3715 (0.13038)
28-day dosing schedule: Week 16: Serotype 43	1.3909 (0.75449)
28-day dosing schedule: Week 16: Serotype 5	2.2704 (0.91895)
28-day dosing schedule: Week 16: Serotype 51	1.9760 (0.45341)
28-day dosing schedule: Week 16: Serotype 54	2.4786 (0.70417)
28-day dosing schedule: Week 16: Serotype 56	3.6552 (8.34613)
28-day dosing schedule: Week 16: Serotype 57	7.7851 (14.9518)
28-day dosing schedule: Week 16: Serotype 68	1.0037 (0.43741)
28-day dosing schedule: Week 16: Serotype 70	1.8656 (1.16519)
28-day dosing schedule: Week 16: Serotype 8	1.6553 (0.54282)
28-day dosing schedule: Week 16: Serotype 9	0.8174 (0.30539)
21-day dosing schedule: Week 18: Serotype 1	6.8000 (8.72068)
21-day dosing schedule: Week 18: Serotype 12	0.6759 (0.07969)
21-day dosing schedule: Week 18: Serotype 14	8.3407 (4.11626)
21-day dosing schedule: Week 18: Serotype 17	3.3332 (2.49783)
21-day dosing schedule: Week 18: Serotype 19	4.1177 (1.24514)
21-day dosing schedule: Week 18: Serotype 2	3.1566 (1.78858)
21-day dosing schedule: Week 18: Serotype 20	4.0521 (2.44372)
21-day dosing schedule: Week 18: Serotype 22	1.3653 (0.45325)
21-day dosing schedule: Week 18: Serotype 23	1.6720 (0.80975)
21-day dosing schedule: Week 18: Serotype 26	2.5183 (2.29821)
21-day dosing schedule: Week 18: Serotype 3	9.6039 (13.55999)
21-day dosing schedule: Week 18: Serotype 34	1.4352 (0.21030)
21-day dosing schedule: Week 18: Serotype 4	0.7559 (0.61634)
21-day dosing schedule: Week 18: Serotype 43	1.9271 (0.61773)
21-day dosing schedule: Week 18: Serotype 5	3.0491 (0.47615)
21-day dosing schedule: Week 18: Serotype 51	11.8744 (15.99966)
21-day dosing schedule: Week 18: Serotype 54	8.7747 (10.40792)
21-day dosing schedule: Week 18: Serotype 56	13.4544 (19.77749)
21-day dosing schedule: Week 18: Serotype 57	3.7348 (0.38721)
21-day dosing schedule: Week 18: Serotype 68	1.8682 (1.69358)
21-day dosing schedule: Week 18: Serotype 70	2.0323 (0.31507)
21-day dosing schedule: Week 18: Serotype 8	4.2572 (3.86929)
21-day dosing schedule: Week 18: Serotype 9	1.5159 (0.65747)

79. Secondary Outcome

Title	Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Description	The peak trough fluctuation within complete dosing interval at steady state of anti-pneumococcal capsular polysaccharide was reported. The peak trough fluctuation for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time Frame	At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion

Outcome Measure Data

Analysis Population Description

PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.

Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
Measure Participants	22
28-day dosing schedule: Week 16: Serotype 1	128.3177 (62.60668)
28-day dosing schedule: Week 16: Serotype 12	125.2166 (64.54247)
28-day dosing schedule: Week 16: Serotype 14	107.5731 (40.60933)
28-day dosing schedule: Week 16: Serotype 17	103.6118 (35.89546)
28-day dosing schedule: Week 16: Serotype 19	110.9054 (50.44522)
28-day dosing schedule: Week 16: Serotype 2	105.2306 (55.00248)
28-day dosing schedule: Week 16: Serotype 20	114.6004 (41.03380)
28-day dosing schedule: Week 16: Serotype 22	128.1639 (58.30342)
28-day dosing schedule: Week 16: Serotype 23	116.7754 (45.77432)
28-day dosing schedule: Week 16: Serotype 26	122.7546 (65.89653)
28-day dosing schedule: Week 16: Serotype 3	139.1737 (50.45738)
28-day dosing schedule: Week 16: Serotype 34	112.0465 (48.26345)
28-day dosing schedule: Week 16: Serotype 4	117.2909 (65.62829)
28-day dosing schedule: Week 16: Serotype 43	125.0358 (49.91946)
28-day dosing schedule: Week 16: Serotype 5	124.7428 (49.15063)
28-day dosing schedule: Week 16: Serotype 51	110.9231 (48.65621)
28-day dosing schedule: Week 16: Serotype 54	123.3022 (53.42626)
28-day dosing schedule: Week 16: Serotype 56	116.6480 (52.81535)
28-day dosing schedule: Week 16: Serotype 57	111.5242 (42.65179)
28-day dosing schedule: Week 16: Serotype 68	114.0701 (58.01418)
28-day dosing schedule: Week 16: Serotype 70	109.4081 (43.80010)
28-day dosing schedule: Week 16: Serotype 8	117.3221 (38.97972)
28-day dosing schedule: Week 16: Serotype 9	130.6095 (65.79680)
21-day dosing schedule: Week 18: Serotype 1	81.4603 (40.27141)
21-day dosing schedule: Week 18: Serotype 12	102.9813 (10.00904)
21-day dosing schedule: Week 18: Serotype 14	73.9639 (29.28795)
21-day dosing schedule: Week 18: Serotype 17	76.0492 (42.17688)
21-day dosing schedule: Week 18: Serotype 19	94.4390 (30.99072)
21-day dosing schedule: Week 18: Serotype 2	80.1377 (36.22955)
21-day dosing schedule: Week 18: Serotype 20	83.5202 (42.23144)
21-day dosing schedule: Week 18: Serotype 22	91.9216 (20.16314)
21-day dosing schedule: Week 18: Serotype 23	84.5653 (31.15550)
21-day dosing schedule: Week 18: Serotype 26	88.7836 (30.46916)
21-day dosing schedule: Week 18: Serotype 3	90.4017 (39.81294)
21-day dosing schedule: Week 18: Serotype 34	91.6269 (16.96157)
21-day dosing schedule: Week 18: Serotype 4	79.5022 (41.16158)
21-day dosing schedule: Week 18: Serotype 43	81.6962 (28.91186)
21-day dosing schedule: Week 18: Serotype 5	88.6356 (17.56577)
21-day dosing schedule: Week 18: Serotype 51	71.0749 (31.74626)
21-day dosing schedule: Week 18: Serotype 54	72.7200 (31.26330)
21-day dosing schedule: Week 18: Serotype 56	82.4508 (27.11113)
21-day dosing schedule: Week 18: Serotype 57	98.1611 (9.69314)
21-day dosing schedule: Week 18: Serotype 68	82.9015 (37.95746)
21-day dosing schedule: Week 18: Serotype 70	91.3286 (19.12896)
21-day dosing schedule: Week 18: Serotype 8	65.5637 (36.02827)
21-day dosing schedule: Week 18: Serotype 9	75.8333 (30.77330)

Adverse Events

Time Frame	Up to study termination visit (Week 52)
Adverse Event Reporting Description	The SAF included all participants who had received at least 1 dose of study medication.
Arm/Group Title	Kedrion IVIG 10%
Arm/Group Description	Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
All Cause Mortality
	Kedrion IVIG 10%
	Affected / at Risk (%)	# Events
Total	0/47 (0%)
Serious Adverse Events
	Kedrion IVIG 10%
	Affected / at Risk (%)	# Events
Total	4/47 (8.5%)
Hepatobiliary disorders
Cholecystitis acute	1/47 (2.1%)
Metabolism and nutrition disorders
Hyperglycaemia	1/47 (2.1%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/47 (2.1%)
Psychiatric disorders
Depression	1/47 (2.1%)
Vascular disorders
Hypotension	1/47 (2.1%)
Other (Not Including Serious) Adverse Events
	Kedrion IVIG 10%
	Affected / at Risk (%)	# Events
Total	38/47 (80.9%)
Gastrointestinal disorders
Nausea	11/47 (23.4%)
Diarrhoea	7/47 (14.9%)
Toothache	3/47 (6.4%)
General disorders
Fatigue	12/47 (25.5%)
Pyrexia	6/47 (12.8%)
Chills	3/47 (6.4%)
Pain	3/47 (6.4%)
Infections and infestations
upper respiratory tract infection	8/47 (17%)
Bronchitis	4/47 (8.5%)
Influenzae	3/47 (6.4%)
Injury, poisoning and procedural complications
Skin laceration	3/47 (6.4%)
Investigations
Coombs direct test positive	6/47 (12.8%)
Musculoskeletal and connective tissue disorders
Myalgia	4/47 (8.5%)
Arthralgia	3/47 (6.4%)
Musculoskeletal pain	3/47 (6.4%)
Neck pain	3/47 (6.4%)
Pain in extremity	3/47 (6.4%)
Nervous system disorders
Headache	19/47 (40.4%)
Sinusitis	11/47 (23.4%)
Dizziness	3/47 (6.4%)
Psychiatric disorders
Depression	6/47 (12.8%)
Insomnia	3/47 (6.4%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	8/47 (17%)
Cough	3/47 (6.4%)
Nasal congestion	3/47 (6.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The results of the Investigators can be divulged to third parties from the trial team only after Kedrion's approval.