Trial Outcomes & Findings for Phase 2/3 Study of IGSC, 20% in PIDD (NCT NCT01218438)

Results Overview

Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant. The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

86 participants

Primary outcome timeframe

1 year

Results posted on

2021-07-20

Participant Flow

Participants were enrolled (signed informed consent) at 15 sites.

A total of 86 participants provided informed consent. 9 of these participants did not start Epoch1, of which there were 6 screen failures; 2 were not able to receive their first infusion according to protocol timeline; and 1 withdrew. Therefore, 77 participants started Epoch 1 of the study.

Participant milestones

Participant milestones
Measure	Study Participants \- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study. - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Epoch 1 STARTED	77
Epoch 1 COMPLETED	74
Epoch 1 NOT COMPLETED	3
Epoch 2 STARTED	45
Epoch 2 COMPLETED	45
Epoch 2 NOT COMPLETED	0
Epoch 3 STARTED	74
Epoch 3 COMPLETED	70
Epoch 3 NOT COMPLETED	4
Epoch 4 STARTED	70
Epoch 4 COMPLETED	67
Epoch 4 NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Participants \- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study. - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Epoch 1 Physician Decision	2
Epoch 1 Adverse Event	1
Epoch 3 Withdrawal by Subject	3
Epoch 3 Adverse Event	1
Epoch 4 Physician Decision	1
Epoch 4 Withdrawal by Subject	2

Baseline Characteristics

Phase 2/3 Study of IGSC, 20% in PIDD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Epochs 1-4 n=77 Participants \- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study. - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Age, Continuous	36.0 Years n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Safety Analysis Set

Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant. The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit.

Outcome measures

Outcome measures
Measure	Study Participants n=74 Participants	Subcutaneous 20% - Epochs 2 Thru 4 \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Rate of Acute Serious Bacterial Infections Per Year (ASBI)	0.012 Estimated infections/ year	—	—	—	—	—

SECONDARY outcome

Timeframe: 1 year

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Annual Rate of All Infections Per Participant	3.86 Estimated infections/year Interval 2.77 to 5.22	2.41 Estimated infections/year Interval 1.89 to 3.03	—	—	—	—

SECONDARY outcome

Timeframe: 1 year

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Annual Rate of Sinus Infections Per Participant	0.97 Estimated infections/year Interval 0.61 to 1.45	0.69 Estimated infections/year Interval 0.5 to 0.93	—	—	—	—

SECONDARY outcome

Timeframe: 1 year

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Annual Rate of Fever Episodes Per Participant	0.61 Estimated episodes/year Interval 0.34 to 0.99	0.13 Estimated episodes/year Interval 0.08 to 0.21	—	—	—	—

SECONDARY outcome

Timeframe: 1 year

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant	3.20 Estimated days off/participant Interval 1.88 to 5.03	1.16 Estimated days off/participant Interval 0.7 to 1.79	—	—	—	—

SECONDARY outcome

Timeframe: 1 year

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Annual Rate of Days on Antibiotics Per Participant	63.20 Estimated days/particpant Interval 43.39 to 88.29	57.59 Estimated days/particpant Interval 40.71 to 78.59	—	—	—	—

SECONDARY outcome

Timeframe: 1 year

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Annual Rate of Hospitalizations for Illness or Infection Per Participant	0.05 Estimated hospitalizations/participant Interval 0.02 to 0.1	0.02 Estimated hospitalizations/participant Interval 0.01 to 0.04	—	—	—	—

SECONDARY outcome

Timeframe: 1 year

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant	0.20 Estimated days/participant Interval 0.08 to 0.42	0.11 Estimated days/participant Interval 0.05 to 0.2	—	—	—	—

SECONDARY outcome

Timeframe: 1 year

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant	1.73 Estimated visits/participant Interval 1.03 to 2.68	0.86 Estimated visits/participant Interval 0.54 to 1.28	—	—	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV administration interval: Week 10, 11, 12, 13. Epoch 1: 4 week IV interval: Week 9, 10, 11, 12, 13. Epoch 4 Subcutaneous administration weeks 17, 18

Population: Safety Analysis Set with correctly administered IGIV 10% dose in Epoch 1

IGSC, 20% = Immune Globulin Subcutaneous (Human), 20% Solution; AUCSC = area under the concentration-time curve following subcutaneous administration; AUCIV,0-τ = area under the concentration-time curve following intravenous administration over a dosing interval

Outcome measures

Outcome measures
Measure	Study Participants n=49 Participants	Subcutaneous 20% - Epochs 2 Thru 4 \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Bioavailability of IGSC, 20% as Measured by the Ratio of the Geometric Means of Immunoglobulin G (IgG) AUCSC (Epoch 4) to IgG AUCIV,0-τ (Standardized to 1 Week) (Epoch 1) Adjusted for Dose and Dosing Frequency (Participants ≥12 Years Old)	1.0855 Ratio Interval 1.0394 to 1.1336	—	—	—	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval- weeks 0, 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 0, 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)

Population: Safety Analysis Set - sub-groups with data at relevant time points

Outcome measures

Outcome measures
Measure	Study Participants n=19 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=50 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=27 Participants	SC 20% Adjusted 1 Week n=66 Participants	SC 20% Individualized 1 Week n=57 Participants	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals Total IgG	11.58 g/L Interval 10.36 to 12.94	10.19 g/L Interval 9.55 to 10.88	14.77 g/L Interval 13.86 to 15.74	14.20 g/L Interval 13.48 to 14.96	14.74 g/L Interval 14.03 to 15.48	—
Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals IgG Subclass 1	6.23 g/L Interval 5.47 to 7.09	5.45 g/L Interval 5.04 to 5.91	8.06 g/L Interval 7.51 to 8.65	7.83 g/L Interval 7.33 to 8.38	7.41 g/L Interval 6.98 to 7.87	—
Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals IgG Subclass 2	3.92 g/L Interval 3.53 to 4.35	3.30 g/L Interval 3.08 to 3.54	4.83 g/L Interval 4.47 to 5.21	4.95 g/L Interval 4.65 to 5.26	4.94 g/L Interval 4.69 to 5.2	—
Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals IgG Subclass 3	0.352 g/L Interval 0.285 to 0.435	0.405 g/L Interval 0.347 to 0.473	0.516 g/L Interval 0.463 to 0.574	0.514 g/L Interval 0.458 to 0.578	0.514 g/L Interval 0.456 to 0.58	—
Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals IgG Subclass 4	0.239 g/L Interval 0.202 to 0.281	0.186 g/L Interval 0.165 to 0.209	0.309 g/L Interval 0.273 to 0.35	0.304 g/L Interval 0.28 to 0.331	0.311 g/L Interval 0.289 to 0.335	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)

Population: Safety Analysis Set - sub-groups with data at relevant time points

Outcome measures

Outcome measures
Measure	Study Participants n=64 Participants	Subcutaneous 20% - Epochs 2 Thru 4 \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Trough Levels of Anti-Tetanus Antibody Pre-Study Medication- Epoch 1 Week 1 (N= 64)	2.28 IU/mL Interval 1.84 to 2.82	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody IV 10% 3 Weeks- Epoch 1 Week 4 (N= 15)	3.36 IU/mL Interval 2.44 to 4.63	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody IV 10% 3 Weeks- Epoch 1 Week 7 (N= 16)	2.66 IU/mL Interval 2.04 to 3.48	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody IV 10% 3 Weeks - Epoch 1 Week 10 (N= 19)	2.55 IU/mL Interval 1.83 to 3.56	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody IV 10% 3 Weeks- Epoch 1 Week 13 (N= 16)	2.26 IU/mL Interval 1.52 to 3.37	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody IV 10% 4 Weeks- Epoch 1 Week 5 (N= 46)	1.92 IU/mL Interval 1.44 to 2.56	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody IV 10% 4 Weeks- Epoch 1 Week 9 (N= 44)	2.31 IU/mL Interval 1.79 to 2.96	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody IV 10% 4 Weeks- Epoch 1 Week 13 (N= 43)	2.28 IU/mL Interval 1.84 to 2.81	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody SC 20% 145% IV 1 Week- Epoch 2 Week 5 (N= 29)	4.08 IU/mL Interval 3.12 to 5.33	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody SC 20% 145% IV 1 Week- Epoch 2 Week 9 (N= 27)	4.49 IU/mL Interval 3.32 to 6.08	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody SC 20% adjusted 1 Week- Epoch 3 Week 5 (N= 55)	3.76 IU/mL Interval 3.21 to 4.4	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody SC 20% adjusted 1 Week- Epoch 3 Week 9 (N= 58)	3.09 IU/mL Interval 2.64 to 3.62	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody SC 20% adjusted 1 Week- Epoch 4 Week 1 (N= 62)	2.75 IU/mL Interval 2.39 to 3.17	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody SC 20% individualized 1 Week Epoch 4 Week 9 (N=58)	3.15 IU/mL Interval 2.73 to 3.63	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody SC 20% individualized 1 Week Epoch 4 Week 17(N=51)	3.17 IU/mL Interval 2.74 to 3.67	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody SC 20% individualized 1 Week Epoch 4 Week 29(N=54)	1.74 IU/mL Interval 1.48 to 2.03	—	—	—	—	—
Trough Levels of Anti-Tetanus Antibody SC 20% individualized 1 Week- End of Study (N= 53)	1.97 IU/mL Interval 1.66 to 2.32	—	—	—	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)

Population: Safety Analysis Set - sub-groups with data at relevant time points

Outcome measures

Outcome measures
Measure	Study Participants n=65 Participants	Subcutaneous 20% - Epochs 2 Thru 4 \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Trough Levels of Anti-Haemophilus Influenza B Antibody Pre-Study Medication- Epoch 1 Week 1 (N= 65)	2.91 mg/L Interval 2.55 to 3.34	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody IV 10% 3 Weeks- Epoch 1 Week 4 (N= 15)	2.71 mg/L Interval 2.07 to 3.56	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody IV 10% 3 Weeks- Epoch 1 Week 7 (N= 16)	3.08 mg/L Interval 2.36 to 4.01	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody IV 10% 3 Weeks- Epoch 1 Week 10 (N= 19)	2.42 mg/L Interval 1.75 to 3.36	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody IV 10% 3 Weeks- Epoch 1 Week 13 (N= 14)	2.47 mg/L Interval 1.85 to 3.29	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody IV 10% 4 Weeks- Epoch 1 Week 5 (N= 45)	2.82 mg/L Interval 2.3 to 3.46	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody IV 10% 4 Weeks- Epoch 1 Week 9 (N= 44)	2.71 mg/L Interval 2.23 to 3.3	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody IV 10% 4 Weeks- Epoch 1 Week 13 (N= 43)	2.74 mg/L Interval 2.2 to 3.42	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody SC 20% 145% IV 1 Week- Epoch 2 Week 5 (N= 29)	4.07 mg/L Interval 3.44 to 4.83	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody SC 20% 145% IV 1 Week- Epoch 2 Week 9 (N= 27)	3.94 mg/L Interval 3.3 to 4.71	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody SC 20% adjusted 1 Week- Epoch 3 Week 5 (N= 56)	3.59 mg/L Interval 3.12 to 4.14	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody SC 20% adjusted 1 Week- Epoch 3 Week 9 (N= 58)	3.62 mg/L Interval 3.1 to 4.22	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody SC 20% adjusted 1 Week- Epoch 4 Week 1 (N= 62)	3.47 mg/L Interval 3.06 to 3.94	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody SC 20% individualized 1 Week Epoch 4 Week 9 (N=58)	4.35 mg/L Interval 3.87 to 4.89	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody SC 20% individualized 1 Week Epoch 4 Week 17(N=51)	4.76 mg/L Interval 4.21 to 5.39	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody SC 20% individualized 1 Week Epoch 4 Week 29(N=54)	4.06 mg/L Interval 3.55 to 4.65	—	—	—	—	—
Trough Levels of Anti-Haemophilus Influenza B Antibody SC 20% individualized 1 Week- End of Study (N= 52)	5.07 mg/L Interval 4.48 to 5.73	—	—	—	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)

Population: Safety Analysis Set - sub-groups with data at relevant time points

Outcome measures

Outcome measures
Measure	Study Participants n=66 Participants	Subcutaneous 20% - Epochs 2 Thru 4 \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Trough Levels of Anti-Hepatitis B Antibody IV 10% 3 Weeks- Epoch 1 Week 10 (N= 19)	376.6 mIU/mL Interval 315.7 to 449.3	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody Pre-Study Medication- Epoch 1 Week 1 (N= 66)	266.6 mIU/mL Interval 232.3 to 305.9	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody IV 10% 3 Weeks- Epoch 1 Week 4 (N= 15)	357.8 mIU/mL Interval 312.2 to 410.1	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody IV 10% 3 Weeks- Epoch 1 Week 7 (N= 17)	402.6 mIU/mL Interval 333.4 to 486.0	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody IV 10% 3 Weeks- Epoch 1 Week 13 (N= 16)	392.2 mIU/mL Interval 310.4 to 495.6	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody IV 10% 4 Weeks- Epoch 1 Week 5 (N= 45)	301.1 mIU/mL Interval 266.2 to 340.5	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody IV 10% 4 Weeks- Epoch 1 Week 9 (N= 44)	304.0 mIU/mL Interval 271.0 to 341.0	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody IV 10% 4 Weeks- Epoch 1 Week 13 (N= 43)	296.3 mIU/mL Interval 266.0 to 330.2	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody SC 20% 145% IV 1 Week- Epoch 2 Week 5 (N= 29)	463.7 mIU/mL Interval 425.0 to 506.0	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody SC 20% 145% IV 1 Week- Epoch 2 Week 9 (N= 27)	525.0 mIU/mL Interval 478.1 to 576.5	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody SC 20% adjusted 1 Week- Epoch 3 Week 5 (N= 57)	581.9 mIU/mL Interval 533.4 to 634.9	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody SC 20% adjusted 1 Week- Epoch 3 Week 9 (N= 58)	622.4 mIU/mL Interval 579.8 to 668.1	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody SC 20% adjusted 1 Week- Epoch 4 Week 1 (N= 62)	552.8 mIU/mL Interval 509.7 to 599.6	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody SC 20% individualized 1 Week Epoch 4 Week 9(N= 58)	434.4 mIU/mL Interval 400.4 to 471.2	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody SC 20% individualized 1 Week Epoch 4 Week 17(N=53)	444.5 mIU/mL Interval 408.2 to 484.1	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody SC 20% individualized 1 Week Epoch 4 Week 29(N=54)	389.2 mIU/mL Interval 355.9 to 425.7	—	—	—	—	—
Trough Levels of Anti-Hepatitis B Antibody SC 20% individualized 1 Week- End of Study (N=56)	403.1 mIU/mL Interval 371.7 to 437.1	—	—	—	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

Population: Safety Analysis Set - sub-groups with data at relevant time points

The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week)

Outcome measures

Outcome measures
Measure	Study Participants n=16 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=38 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=18 Participants	SC 20% Adjusted 1 Week n=60 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC)	352.05 g*days/L Interval 319.74 to 387.63	410.40 g*days/L Interval 381.24 to 441.79	108.33 g*days/L Interval 97.6 to 120.24	115.21 g*days/L Interval 109.23 to 121.52	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

Population: Safety Analysis Set - sub-groups with data at relevant time points

The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.

Outcome measures

Outcome measures
Measure	Study Participants n=16 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=38 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=18 Participants	SC 20% Adjusted 1 Week n=60 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC)	606.99 (g*days/L)/(g/kg) Interval 495.29 to 743.87	796.30 (g*days/L)/(g/kg) Interval 715.36 to 886.4	472.50 (g*days/L)/(g/kg) Interval 411.07 to 543.1	536.05 (g*days/L)/(g/kg) Interval 495.58 to 579.82	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

Population: Safety Analysis Set - sub-groups with data at relevant time point

Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0-τ). (F= bioavailability)

Outcome measures

Outcome measures
Measure	Study Participants n=16 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=38 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=18 Participants	SC 20% Adjusted 1 Week n=60 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC)	1.65 mL/kg/days Interval 1.34 to 2.02	1.26 mL/kg/days Interval 1.13 to 1.4	2.12 mL/kg/days Interval 1.84 to 2.43	1.87 mL/kg/days Interval 1.72 to 2.02	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

Population: Safety Analysis Set - sub-groups with data at relevant time points

The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).

Outcome measures

Outcome measures
Measure	Study Participants n=16 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=38 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=18 Participants	SC 20% Adjusted 1 Week n=60 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax)	27.09 g/L Interval 24.3 to 30.19	24.85 g/L Interval 23.18 to 26.64	17.31 g/L Interval 15.11 to 19.82	19.31 g/L Interval 18.13 to 20.57	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

Population: Safety Analysis Set - sub-groups with data at relevant time points

The minimum time (Tmax) to reach the maximum concentration (Cmax)

Outcome measures

Outcome measures
Measure	Study Participants n=16 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=38 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=18 Participants	SC 20% Adjusted 1 Week n=60 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax)	6.94 hours (h) Interval 3.96 to 12.17	5.84 hours (h) Interval 3.62 to 9.4	54.19 hours (h) Interval 36.28 to 80.92	78.68 hours (h) Interval 65.37 to 94.7	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

Population: Safety Analysis Set - sub-groups with data at relevant time points

The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).

Outcome measures

Outcome measures
Measure	Study Participants n=16 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=38 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=18 Participants	SC 20% Adjusted 1 Week n=60 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin)	12.03 g/L Interval 10.64 to 13.6	10.37 g/L Interval 9.5 to 11.33	13.85 g/L Interval 12.61 to 15.21	14.00 g/L Interval 13.14 to 14.91	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

Population: Safety Analysis Set - sub-groups with data at relevant time points

The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week )

Outcome measures

Outcome measures
Measure	Study Participants n=16 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=37 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=18 Participants	SC 20% Adjusted 1 Week n=59 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC)	80.79 mg*days/L Interval 65.58 to 99.53	123.05 mg*days/L Interval 93.36 to 162.18	29.51 mg*days/L Interval 23.25 to 37.46	30.64 mg*days/L Interval 26.29 to 35.72	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

Population: Safety Analysis Set - sub-groups with data at relevant time points

The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.

Outcome measures

Outcome measures
Measure	Study Participants n=16 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=37 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=18 Participants	SC 20% Adjusted 1 Week n=59 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC)	139.29 (mg*days/L)/(g/kg) Interval 110.89 to 174.97	239.99 (mg*days/L)/(g/kg) Interval 181.92 to 316.61	128.72 (mg*days/L)/(g/kg) Interval 96.65 to 171.42	141.78 (mg*days/L)/(g/kg) Interval 121.75 to 165.12	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

Population: Safety Analysis Set - sub-groups with data at relevant time points

Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0- τ). (F= bioavailability)

Outcome measures

Outcome measures
Measure	Study Participants n=16 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=37 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=18 Participants	SC 20% Adjusted 1 Week n=59 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously	7.18 mL/kg/days Interval 5.72 to 9.02	4.17 mL/kg/days Interval 3.16 to 5.5	7.77 mL/kg/days Interval 5.83 to 10.35	7.05 mL/kg/days Interval 6.06 to 8.21	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

Population: Safety Analysis Set - sub-groups with data at relevant time points

The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).

Outcome measures

Outcome measures
Measure	Study Participants n=16 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=37 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=18 Participants	SC 20% Adjusted 1 Week n=59 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax)	6.31 mg/L Interval 5.25 to 7.59	7.22 mg/L Interval 5.75 to 9.05	4.40 mg/L Interval 3.45 to 5.62	4.86 mg/L Interval 4.16 to 5.68	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

Population: Safety Analysis Set - sub-groups with data at relevant time points

The minimum time (Tmax) to reach the maximum concentration (Cmax)

Outcome measures

Outcome measures
Measure	Study Participants n=16 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=37 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=18 Participants	SC 20% Adjusted 1 Week n=59 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax)	3.11 Hours (s) Interval 2.69 to 3.59	3.71 Hours (s) Interval 2.69 to 5.12	70.67 Hours (s) Interval 51.14 to 97.66	66.87 Hours (s) Interval 56.22 to 79.53	—	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

Population: Safety Analysis Set - sub-groups with data at relevant time points

The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).

Outcome measures

Outcome measures
Measure	Study Participants n=16 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=37 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=18 Participants	SC 20% Adjusted 1 Week n=59 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin)	2.82 mg/L Interval 2.2 to 3.61	3.13 mg/L Interval 2.31 to 4.26	3.97 mg/L Interval 3.14 to 5.01	3.71 mg/L Interval 3.15 to 4.37	—	—

SECONDARY outcome

Timeframe: 29 weeks

Population: Pharmacokinetics interim analysis set to determine the Individually Adapted Dose for Epoch 4

There is a high degree of variability in catabolism of immunoglobulin G (IgG) between individuals. To address this, trough levels immediately prior to the 9th weekly infusion in Epoch 3 were measured. The ratio of the measured trough levels on subcutaneous (SC) (Epoch 3) and intravenous (IV) administration (Epoch1) were compared to the expected trough level determined in Epoch 2. This was used to determine the Individually Adapted Dose to be used in Epoch 4. This was an interim study analysis.

Outcome measures

Outcome measures
Measure	Study Participants n=15 Participants	Subcutaneous 20% - Epochs 2 Thru 4 \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 0.93 or more	1.16 Correction factor	—	—	—	—	—
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 0.94	1.14 Correction factor	—	—	—	—	—
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 0.95 to 0.96	1.12 Correction factor	—	—	—	—	—
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 0.97 to 0.98	1.11 Correction factor	—	—	—	—	—
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 0.99 to 1.01	1.10 Correction factor	—	—	—	—	—
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 1.02 to 1.04	1.09 Correction factor	—	—	—	—	—
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 1.05 to 1.08	1.08 Correction factor	—	—	—	—	—
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 1.09 to 1.13	1.07 Correction factor	—	—	—	—	—
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 1.14 to 1.19	1.06 Correction factor	—	—	—	—	—
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 1.20 to 1.26	1.05 Correction factor	—	—	—	—	—
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 1.27 to 1.33	1.04 Correction factor	—	—	—	—	—
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 1.34 to 1.40	1.03 Correction factor	—	—	—	—	—
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 1.41 to 1.47	1.02 Correction factor	—	—	—	—	—
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 1.48 to 1.55	1.01 Correction factor	—	—	—	—	—
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) Trough Level Ratio: 1.56 to 1.63	1.00 Correction factor	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 20 months per subject (throughout entire study)

Population: Safety Analysis Set

Number of related SAEs and AEs divided by number of participants

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant Non-SAEs - Including infections	1.039 Adverse events per participant	2.122 Adverse events per participant	—	—	—	—
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant Non-SAEs - Excluding infections	1.039 Adverse events per participant	2.122 Adverse events per participant	—	—	—	—
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant SAEs - Including infections	0.013 Adverse events per participant	0 Adverse events per participant	—	—	—	—
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant SAEs - Excluding infections	0.013 Adverse events per participant	0 Adverse events per participant	—	—	—	—

SECONDARY outcome

Timeframe: Up to 20 months per subject (throughout entire study)

Population: Safety Analysis Set

Number of related SAEs and AEs divided by number of subjects and divided by number of infusions

Outcome measures

Outcome measures
Measure	Study Participants n=324 Infusions	Subcutaneous 20% - Epochs 2 Thru 4 n=4327 Infusions \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion Non-SAEs - Including Infections	0.247 Adverse events per infusion	0.036 Adverse events per infusion	—	—	—	—
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion Non-SAEs -Excluding Infections	0.247 Adverse events per infusion	0.036 Adverse events per infusion	—	—	—	—
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion SAEs - Including Infections	0.003 Adverse events per infusion	0 Adverse events per infusion	—	—	—	—
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion SAEs -Excluding Infections	0.003 Adverse events per infusion	0 Adverse events per infusion	—	—	—	—

SECONDARY outcome

Timeframe: Up to 20 months per subject (throughout entire study)

Population: Safety Analysis Set

Number of all SAEs and AEs divided by number of participants

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant Non-SAEs - Including infections	3.325 Adverse events per participant	9.014 Adverse events per participant	—	—	—	—
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant Non-SAEs - Excluding infections	2.338 Adverse events per participant	6.297 Adverse events per participant	—	—	—	—
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant SAEs - Including infections	0.013 Adverse events per participant	0.027 Adverse events per participant	—	—	—	—
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant SAEs - Excluding infections	0.013 Adverse events per participant	0.014 Adverse events per participant	—	—	—	—

SECONDARY outcome

Timeframe: Up to 20 months per subject (throughout entire study)

Population: Safety Analysis Set

Number of all SAEs and AEs divided by number of infusions

Outcome measures

Outcome measures
Measure	Study Participants n=324 Infusions	Subcutaneous 20% - Epochs 2 Thru 4 n=4327 Infusions \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion Non-SAEs - Including infections	0.390 Adverse events per infusion	0.114 Adverse events per infusion	—	—	—	—
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion Non-SAEs - Excluding infections	0.296 Adverse events per infusion	0.079 Adverse events per infusion	—	—	—	—
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion SAEs - including infections	0.003 Adverse events per infusion	0.000 Adverse events per infusion	—	—	—	—
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion SAEs - Excluding infections	0.003 Adverse events per infusion	0.000 Adverse events per infusion	—	—	—	—

SECONDARY outcome

Timeframe: Within 72 hours of completion of infusion

Population: Safety Analysis Set

Number of AEs that begin during or within 72 hours of completion of infusion divided by number of participants

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant Non-SAEs - Including infections	1.377 Adverse events per participant	4.581 Adverse events per participant	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant Non-SAEs - Excluding infections	1.260 Adverse events per participant	3.703 Adverse events per participant	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant SAEs - Including infections	0.013 Adverse events per participant	0 Adverse events per participant	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant SAEs - Excluding infections	0.013 Adverse events per participant	0 Adverse events per participant	—	—	—	—

SECONDARY outcome

Timeframe: Within 72 hours of completion of infusion

Population: Safety Analysis Set

Number of AEs that begin during or within 72 hours of completion of infusion divided by the number of infusions

Outcome measures

Outcome measures
Measure	Study Participants n=324 Infusions	Subcutaneous 20% - Epochs 2 Thru 4 n=4327 Infusions \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion Non-SAEs - Including infections	0.327 Adverse events per infusion	0.078 Adverse events per infusion	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion Non-SAEs - Excluding infections	0.299 Adverse events per infusion	0.063 Adverse events per infusion	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion SAEs - Including infections	0.003 Adverse events per infusion	0 Adverse events per infusion	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion SAEs - Excluding infections	0.003 Adverse events per infusion	0 Adverse events per infusion	—	—	—	—

SECONDARY outcome

Timeframe: Within 24 hours of completion of infusion

Population: Safety Analysis Set

Number of AEs that begin during or within 24 hours of completion of infusion divided by number of participants

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant Non-SAEs - Including infections	0.961 Adverse events per participant	3.365 Adverse events per participant	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant Non-SAEs - Excluding infections	0.948 Adverse events per participant	3.027 Adverse events per participant	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant SAEs - Including infections	0 Adverse events per participant	0 Adverse events per participant	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant SAEs - Excluding infections	0 Adverse events per participant	0 Adverse events per participant	—	—	—	—

SECONDARY outcome

Timeframe: Within 24 hours of completion of infusion

Population: Safety Analysis Set

Number of AEs that begin during or within 24 hours of completion of infusion divided by number of infusions

Outcome measures

Outcome measures
Measure	Study Participants n=324 Infusions	Subcutaneous 20% - Epochs 2 Thru 4 n=4327 Infusions \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion Non-SAEs - Including infections	0.228 Adverse events per infusion	0.058 Adverse events per infusion	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion Non-SAEs - Excluding infections	0.225 Adverse events per infusion	0.052 Adverse events per infusion	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion SAEs - Including infections	0 Adverse events per infusion	0 Adverse events per infusion	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion SAEs - Excluding infections	0 Adverse events per infusion	0 Adverse events per infusion	—	—	—	—

SECONDARY outcome

Timeframe: Within 1 hour of completion of infusion

Population: Safety Analysis Set

Number of AEs that begin during or within 1 hour of completion of infusion divided by number of participants

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant Non-SAEs - Including infections	0.662 Adverse events per participant	1.865 Adverse events per participant	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant Non-SAEs - Excluding infections	0.662 Adverse events per participant	1.797 Adverse events per participant	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant SAEs - Including infections	0 Adverse events per participant	0 Adverse events per participant	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant SAEs - Excluding infections	0 Adverse events per participant	0 Adverse events per participant	—	—	—	—

SECONDARY outcome

Timeframe: Within 1 hour of completion of infusion

Population: Safety Analysis Set

Number of AEs that begin during or within 1 hour of completion of infusion divided by number of infusions

Outcome measures

Outcome measures
Measure	Study Participants n=324 Infusions	Subcutaneous 20% - Epochs 2 Thru 4 n=4327 Infusions \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Non-SAEs - Including infections	0.157 Adverse events per infusion	0.032 Adverse events per infusion	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Non-SAEs - Excluding infections	0.157 Adverse events per infusion	0.031 Adverse events per infusion	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion SAEs - Including infections	0 Adverse events per infusion	0 Adverse events per infusion	—	—	—	—
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion SAEs - Excluding infections	0 Adverse events per infusion	0 Adverse events per infusion	—	—	—	—

SECONDARY outcome

Timeframe: Within 72 hours post infusion for Temporally Associated AEs; End of each Study Epoch (Epoch 1, Epoch 2, Epoch 3, and Epoch 4) for Causally Related AEs

Population: Safety Analysis Set

The total number of all AEs (including and excluding infections) that begin during infusion or within 72 hours of completion of an infusion ("temporally associated") plus the total number of AEs (including and excluding infections) starting more than 72 hours following the completion of an infusion determined by the investigator to be at least possibly related to the study drug("related"), divided by the total number of infusions

Outcome measures

Outcome measures
Measure	Study Participants n=324 Infusions	Subcutaneous 20% - Epochs 2 Thru 4 n=4327 Infusions \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion Non-SAEs - Including infections	0.336 Adverse events per infusion	0.079 Adverse events per infusion	—	—	—	—
Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion Non-SAEs - Excluding infections	0.309 Adverse events per infusion	0.064 Adverse events per infusion	—	—	—	—
Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion SAEs - Including infections	0.003 Adverse events per infusion	0 Adverse events per infusion	—	—	—	—
Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion SAEs - Excluding infections	0.003 Adverse events per infusion	0 Adverse events per infusion	—	—	—	—

SECONDARY outcome

Timeframe: Up to 20 months (throughout entire study)

Population: Safety Analysis Set

The number of infusions associated with local non-SAEs divided by the total number of infusions.

Outcome measures

Outcome measures
Measure	Study Participants n=324 Infusions	Subcutaneous 20% - Epochs 2 Thru 4 n=4327 Infusions \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Percentage of Infusions Associated With One or More Local Non-serious Adverse Events (Non-SAEs)	0.9 Percent of infusions	1.8 Percent of infusions	—	—	—	—

SECONDARY outcome

Timeframe: Up to 20 months (throughout entire study)

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs)	3.9 Percent of participants	31.1 Percent of participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to 20 months (throughout entire study)

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Study Participants n=324 Infusions	Subcutaneous 20% - Epochs 2 Thru 4 n=4327 Infusions \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs Infusion rate reduced	4 Infusions	5 Infusions	—	—	—	—
Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs Infusion interrupted	5 Infusions	2 Infusions	—	—	—	—
Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs Infusion stopped	0 Infusions	1 Infusions	—	—	—	—

SECONDARY outcome

Timeframe: Up to 20 months (throughout entire study)

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs Infusion rate reduced	1.3 Percent of participants	5.4 Percent of participants	—	—	—	—
Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs Infusion interrupted	6.5 Percent of participants	1.4 Percent of participants	—	—	—	—
Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs Infusion stopped	0.0 Percent of participants	1.4 Percent of participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to 20 months (throughout entire study)

Population: Safety Analysis Set

An infusion will be deemed as tolerated unless one of the following occurs: 1. Any serious related AE(s) 2. Any non-serious local or systemic related AE(s) that prevent(s) completion of infusion 3. Any severe non-serious local or systemic related AE(s) that occur within 60 minutes of completion of the infusion

Outcome measures

Outcome measures
Measure	Study Participants n=324 Infusions	Subcutaneous 20% - Epochs 2 Thru 4 n=4327 Infusions \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Percentage of Infusions Tolerated With Intravenous or Subcutaneous Administration	100 Percent of infusions	100 Percent of infusions	—	—	—	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=72 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=2 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=3 Participants	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 0	61 Participants	1 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 1	10 Participants	1 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 3	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=70 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=2 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=2 Participants	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 3	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 0	62 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 1	5 Participants	2 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 2	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=69 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=2 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=3 Participants	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 0	59 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 1	9 Participants	2 Participants	2 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 2	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=41 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=3 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=1 Participants	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 0	38 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 1	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 2	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 3	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=37 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=3 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week n=1 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 0	35 Participants	2 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 1	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=34 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=1 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week n=1 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 0	32 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 1	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=72 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=1 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=3 Participants	SC 20% Adjusted 1 Week n=1 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 0	69 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 1	2 Participants	0 Participants	2 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 2	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 3	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=71 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=2 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=1 Participants	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 0	67 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 1	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 2	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=71 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=3 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 0	69 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 1	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 2	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=42 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=3 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 0	41 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 1	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 3	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=39 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=1 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=1 Participants	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 0	37 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 1	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=35 Participants	Subcutaneous 20% - Epochs 2 Thru 4 \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=1 Participants	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 0	35 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=71 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=4 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=1 Participants	SC 20% Adjusted 1 Week n=1 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 0	61 Participants	3 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 1	8 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 2	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=66 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=6 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=2 Participants	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 0	53 Participants	3 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 1	9 Participants	2 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 2	4 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 3	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=66 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=5 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=3 Participants	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 1	9 Participants	2 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 0	55 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 2	2 Participants	2 Participants	2 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=43 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=2 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 0	40 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 1	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 2	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=39 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=2 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 0	36 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 1	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 2	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=33 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=3 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 0	32 Participants	2 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 1	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=39 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=35 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=3 Participants	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 0	32 Participants	5 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 1	7 Participants	28 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 2	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=46 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=23 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=3 Participants	SC 20% Adjusted 1 Week n=2 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 0	35 Participants	2 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 1	11 Participants	19 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 2	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 3	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=38 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=32 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=2 Participants	SC 20% Adjusted 1 Week n=2 Participants	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 0	32 Participants	4 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 1	6 Participants	26 Participants	2 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 2	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=27 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=18 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 0	18 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 1	9 Participants	17 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=22 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=19 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 0	18 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 1	4 Participants	18 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=18 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=17 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=1 Participants	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 0	13 Participants	6 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 1	5 Participants	11 Participants	1 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 0	77 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=74 Participants	Subcutaneous 20% - Epochs 2 Thru 4 \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 0	73 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 1	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=74 Participants	Subcutaneous 20% - Epochs 2 Thru 4 \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 0	72 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 1	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=45 Participants	Subcutaneous 20% - Epochs 2 Thru 4 \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 0	45 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=41 Participants	Subcutaneous 20% - Epochs 2 Thru 4 \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 0	41 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

Population: Safety Analysis Set

Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.

Outcome measures

Outcome measures
Measure	Study Participants n=36 Participants	Subcutaneous 20% - Epochs 2 Thru 4 \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 0	36 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 Maximum Post-Infusion Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Epoch 1: 3 week IV interval- weeks 0, 10. Epoch 1: 4 week IV interval- weeks 0, 9. Epoch 3: Subcutaneous (SC) week 9. Epoch 4: SC weeks 17, 18, 40

Population: Safety Analysis Set

Laboratory tests for confirmation of potential hemolysis include Coomb's test, haptoglobin, free hemoglobin, reticulocyte count, lactate dehydrogenase (LDH), and urine hemosiderin.

Outcome measures

Outcome measures
Measure	Study Participants n=77 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=74 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week	SC 20% Adjusted 1 Week	SC 20% Individualized 1 Week	Change End Epoch 1 to End Epoch 4 Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Number of Participants With Laboratory Confirmed Hemolysis That Occurred Following Investigational Product Administration	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to 20 months (throughout entire study)

Population: Safety Analysis Set (subset of participants aged 2 to 7 years)

The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \& school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.

Outcome measures

Outcome measures
Measure	Study Participants n=6 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=6 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=6 Participants	SC 20% Adjusted 1 Week n=6 Participants	SC 20% Individualized 1 Week n=6 Participants	Change End Epoch 1 to End Epoch 4 n=6 Participants Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years Physical Functioning	95.31 Score on a scale Interval 68.75 to 100.0	93.75 Score on a scale Interval 56.25 to 100.0	96.88 Score on a scale Interval 62.5 to 100.0	92.19 Score on a scale Interval 75.0 to 100.0	1.56 Score on a scale Interval -3.13 to 9.38	1.56 Score on a scale Interval -12.5 to 18.75
Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years Emotional Functioning	95.00 Score on a scale Interval 70.0 to 95.0	85.00 Score on a scale Interval 50.0 to 95.0	82.50 Score on a scale Interval 60.0 to 100.0	77.50 Score on a scale Interval 55.0 to 85.0	0.00 Score on a scale Interval -5.0 to 10.0	-2.50 Score on a scale Interval -20.0 to 10.0
Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years Social Functioning	95.00 Score on a scale Interval 65.0 to 100.0	95.00 Score on a scale Interval 25.0 to 100.0	97.50 Score on a scale Interval 25.0 to 100.0	87.50 Score on a scale Interval 50.0 to 100.0	0.00 Score on a scale Interval -5.0 to 10.0	0.00 Score on a scale Interval -15.0 to 25.0
Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years School Functioning	85.00 Score on a scale Interval 55.0 to 100.0	75.00 Score on a scale Interval 30.0 to 83.33	81.67 Score on a scale Interval 40.0 to 100.0	67.50 Score on a scale Interval 25.0 to 91.67	7.50 Score on a scale Interval 0.0 to 25.0	-5.00 Score on a scale Interval -10.0 to 8.33
Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years Psychosocial Health Summary	91.67 Score on a scale Interval 65.0 to 98.08	83.33 Score on a scale Interval 38.33 to 92.31	84.17 Score on a scale Interval 41.67 to 100.0	77.50 Score on a scale Interval 46.67 to 90.38	2.50 Score on a scale Interval 0.0 to 11.67	-3.33 Score on a scale Interval -8.33 to 8.33
Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years Physical Health Summary	95.31 Score on a scale Interval 68.75 to 100.0	93.75 Score on a scale Interval 56.25 to 100.0	96.88 Score on a scale Interval 62.5 to 100.0	92.19 Score on a scale Interval 75.0 to 100.0	1.56 Score on a scale Interval -3.13 to 9.38	1.56 Score on a scale Interval -12.5 to 18.75
Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years Total Score	92.93 Score on a scale Interval 69.57 to 98.81	86.96 Score on a scale Interval 59.78 to 94.05	88.04 Score on a scale Interval 60.87 to 100.0	82.61 Score on a scale Interval 60.87 to 94.05	1.63 Score on a scale Interval 0.0 to 10.87	0.00 Score on a scale Interval -5.43 to 4.35

SECONDARY outcome

Timeframe: Up to 20 months (throughout entire study)

Population: Safety Analysis Set participants aged 8 to 13 with scores at each respective time point.

The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \& school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.

Outcome measures

Outcome measures
Measure	Study Participants n=14 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=15 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=15 Participants	SC 20% Adjusted 1 Week n=14 Participants	SC 20% Individualized 1 Week n=15 Participants	Change End Epoch 1 to End Epoch 4 n=14 Participants Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age Physical Functioning	89.06 Score on a scale Interval 81.25 to 100.0	90.63 Score on a scale Interval 78.13 to 100.0	87.50 Score on a scale Interval 75.0 to 100.0	93.75 Score on a scale Interval 71.88 to 100.0	0.00 Score on a scale Interval -3.13 to 9.38	6.25 Score on a scale Interval 0.0 to 15.63
Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age Emotional Functioning	87.50 Score on a scale Interval 75.0 to 100.0	80.00 Score on a scale Interval 70.0 to 90.0	80.00 Score on a scale Interval 70.0 to 95.0	87.50 Score on a scale Interval 65.0 to 95.0	0.00 Score on a scale Interval -5.0 to 5.0	10.00 Score on a scale Interval -5.0 to 15.0
Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age Social Functioning	87.50 Score on a scale Interval 80.0 to 100.0	95.00 Score on a scale Interval 80.0 to 100.0	95.00 Score on a scale Interval 85.0 to 100.0	95.00 Score on a scale Interval 85.0 to 100.0	0.00 Score on a scale Interval 0.0 to 5.0	0.00 Score on a scale Interval 0.0 to 5.0
Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age School Functioning	75.00 Score on a scale Interval 55.0 to 90.0	80.00 Score on a scale Interval 60.0 to 85.0	75.00 Score on a scale Interval 55.0 to 85.0	70.00 Score on a scale Interval 55.0 to 85.0	0.00 Score on a scale Interval -10.0 to 10.0	-2.50 Score on a scale Interval -15.0 to 10.0
Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age Psychosocial Health Summary	80.83 Score on a scale Interval 76.67 to 91.67	83.33 Score on a scale Interval 71.67 to 91.67	81.67 Score on a scale Interval 75.0 to 93.33	81.67 Score on a scale Interval 78.33 to 91.67	0.00 Score on a scale Interval -3.33 to 8.33	3.33 Score on a scale Interval -1.67 to 10.0
Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age Physical Health Summary	89.06 Score on a scale Interval 81.25 to 100.0	90.63 Score on a scale Interval 78.13 to 100.0	87.50 Score on a scale Interval 75.0 to 100.0	93.75 Score on a scale Interval 71.88 to 100.0	0.00 Score on a scale Interval -3.13 to 9.38	6.25 Score on a scale Interval 0.0 to 15.63
Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age Total Score	86.41 Score on a scale Interval 82.61 to 94.57	89.13 Score on a scale Interval 69.57 to 91.3	81.52 Score on a scale Interval 76.09 to 93.48	85.87 Score on a scale Interval 79.35 to 92.39	1.09 Score on a scale Interval -1.09 to 7.61	2.17 Score on a scale Interval -3.26 to 10.87

SECONDARY outcome

Timeframe: Up to 20 months (throughout entire study)

Population: Safety Analysis Set participants aged 14 years and older with scores at each respective time point.

The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both sub-scores and summary scores.

Outcome measures

Outcome measures
Measure	Study Participants n=56 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=53 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=49 Participants	SC 20% Adjusted 1 Week n=48 Participants	SC 20% Individualized 1 Week n=49 Participants	Change End Epoch 1 to End Epoch 4 n=48 Participants Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older Physical Functioning	48.61 Scores on a scale Interval 46.51 to 52.82	52.82 Scores on a scale Interval 44.41 to 54.93	50.72 Scores on a scale Interval 48.61 to 52.82	50.72 Scores on a scale Interval 46.51 to 54.93	0.00 Scores on a scale Interval -2.1 to 0.0	0.00 Scores on a scale Interval -2.1 to 2.1
Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older Role-Physical	44.61 Scores on a scale Interval 37.26 to 49.51	42.16 Scores on a scale Interval 37.26 to 51.96	49.51 Scores on a scale Interval 42.16 to 54.4	47.06 Scores on a scale Interval 44.61 to 51.96	2.45 Scores on a scale Interval 0.0 to 4.9	2.45 Scores on a scale Interval 0.0 to 4.9
Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older Bodily Pain	43.95 Scores on a scale Interval 41.41 to 51.13	45.64 Scores on a scale Interval 37.18 to 50.29	50.29 Scores on a scale Interval 41.83 to 51.13	46.06 Scores on a scale Interval 41.83 to 51.13	4.23 Scores on a scale Interval 0.0 to 4.65	0.00 Scores on a scale Interval 0.0 to 4.65
Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older General Health	38.63 Scores on a scale Interval 33.87 to 41.02	41.02 Scores on a scale Interval 33.87 to 44.83	38.63 Scores on a scale Interval 36.25 to 45.78	38.63 Scores on a scale Interval 36.25 to 45.78	0.95 Scores on a scale Interval -1.43 to 2.38	0.72 Scores on a scale Interval -2.38 to 2.38
Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older Vitality	42.72 Scores on a scale Interval 39.6 to 48.97	42.72 Scores on a scale Interval 36.48 to 48.97	45.85 Scores on a scale Interval 39.6 to 52.09	48.97 Scores on a scale Interval 42.72 to 52.09	3.12 Scores on a scale Interval 0.0 to 3.12	1.56 Scores on a scale Interval 0.0 to 6.24
Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older Social Functioning	45.94 Scores on a scale Interval 40.49 to 51.4	45.94 Scores on a scale Interval 40.49 to 51.4	51.40 Scores on a scale Interval 45.94 to 51.4	51.40 Scores on a scale Interval 45.94 to 56.85	0.00 Scores on a scale Interval 0.0 to 0.0	0.00 Scores on a scale Interval 0.0 to 5.45
Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older Role-Emotional	51.99 Scores on a scale Interval 44.22 to 55.88	55.88 Scores on a scale Interval 48.1 to 55.88	51.99 Scores on a scale Interval 48.1 to 55.88	53.94 Scores on a scale Interval 44.22 to 55.88	0.00 Scores on a scale Interval 0.0 to 0.0	0.00 Scores on a scale Interval 0.0 to 0.0
Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older Mental Health	50.01 Scores on a scale Interval 47.19 to 52.82	52.82 Scores on a scale Interval 47.19 to 55.64	50.01 Scores on a scale Interval 47.19 to 52.82	52.82 Scores on a scale Interval 50.01 to 55.64	0.00 Scores on a scale Interval -2.82 to 2.82	1.41 Scores on a scale Interval -2.82 to 2.82
Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older Physical Component Summary	41.57 Scores on a scale Interval 38.01 to 47.02	39.93 Scores on a scale Interval 37.57 to 47.98	46.13 Scores on a scale Interval 43.0 to 50.84	46.07 Scores on a scale Interval 42.38 to 49.25	1.22 Scores on a scale Interval -0.51 to 3.29	0.89 Scores on a scale Interval -0.37 to 2.49
Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older Mental Component Summary	49.92 Scores on a scale Interval 45.53 to 51.78	49.45 Scores on a scale Interval 46.87 to 53.58	49.70 Scores on a scale Interval 46.37 to 54.06	51.59 Scores on a scale Interval 48.03 to 54.35	0.57 Scores on a scale Interval -2.17 to 2.39	1.31 Scores on a scale Interval -3.69 to 4.4

SECONDARY outcome

Timeframe: Up to 20 months per subject (throughout entire study)

Population: Safety Analysis Set - participants aged 2-12 years old with data (scores) at relevant time points

TSQM; for the age group 2 to 12 years the observer will be a parent. Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.

Outcome measures

Outcome measures
Measure	Study Participants n=16 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=16 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=16 Participants	SC 20% Adjusted 1 Week n=16 Participants	SC 20% Individualized 1 Week n=16 Participants	Change End Epoch 1 to End Epoch 4 n=16 Participants Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old Effectiveness	83.33 Score on a scale Interval 77.78 to 100.0	88.89 Score on a scale Interval 83.33 to 100.0	83.33 Score on a scale Interval 66.67 to 100.0	91.67 Score on a scale Interval 72.22 to 100.0	0.00 Score on a scale Interval -11.11 to 0.0	0.00 Score on a scale Interval -5.56 to 5.56
Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old Convenience	75.00 Score on a scale Interval 55.56 to 88.89	72.22 Score on a scale Interval 66.67 to 83.33	80.56 Score on a scale Interval 77.78 to 100.0	77.78 Score on a scale Interval 77.78 to 94.44	5.56 Score on a scale Interval 0.0 to 27.78	5.56 Score on a scale Interval 0.0 to 16.67
Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old Global Satisfaction	85.71 Score on a scale Interval 78.57 to 100.0	92.86 Score on a scale Interval 71.43 to 100.0	100.00 Score on a scale Interval 71.43 to 100.0	89.29 Score on a scale Interval 71.43 to 100.0	0.00 Score on a scale Interval 0.0 to 7.14	0.00 Score on a scale Interval 0.0 to 7.14

SECONDARY outcome

Timeframe: Up to 20 months per subject (throughout entire study)

Population: Safety Analysis Set - participants aged 13 years and older with data (scores) at relevant time points

TSQM; for the age group 13 years and older the observer will be the participant. Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.

Outcome measures

Outcome measures
Measure	Study Participants n=61 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=58 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=54 Participants	SC 20% Adjusted 1 Week n=53 Participants	SC 20% Individualized 1 Week n=54 Participants	Change End Epoch 1 to End Epoch 4 n=53 Participants Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older Effectiveness	77.78 Score on a scale Interval 72.22 to 83.33	80.56 Score on a scale Interval 72.22 to 88.89	83.33 Score on a scale Interval 77.78 to 88.89	83.33 Score on a scale Interval 77.78 to 88.89	0.00 Score on a scale Interval 0.0 to 5.56	0.00 Score on a scale Interval 0.0 to 5.56
Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older Convenience	66.67 Score on a scale Interval 61.11 to 77.78	66.67 Score on a scale Interval 55.56 to 72.22	83.33 Score on a scale Interval 72.22 to 83.33	83.33 Score on a scale Interval 77.78 to 88.89	11.11 Score on a scale Interval 5.56 to 16.67	11.11 Score on a scale Interval 5.56 to 16.67
Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older Global Satisfaction	85.71 Score on a scale Interval 78.57 to 92.86	85.71 Score on a scale Interval 78.57 to 92.86	92.86 Score on a scale Interval 78.57 to 92.86	92.86 Score on a scale Interval 85.71 to 92.86	0.00 Score on a scale Interval 0.0 to 7.14	0.00 Score on a scale Interval 0.0 to 7.14

SECONDARY outcome

Timeframe: Up to 20 months (throughout entire study)

Population: Safety Analysis Set - participants aged 2-12 years old with data (scores) at relevant time points

For the age group 2 to 12 years the respondent will be a parent. Each of the four domains has a separate score, each has a different range as follows: Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment.

Outcome measures

Outcome measures
Measure	Study Participants n=16 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=16 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=15 Participants	SC 20% Adjusted 1 Week n=16 Participants	SC 20% Individualized 1 Week n=15 Participants	Change End Epoch 1 to End Epoch 4 n=16 Participants Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Life Quality Index - 2 to 12 Years Old Treatment Interference	32.0 Score on a scale Interval 27.0 to 40.0	31.0 Score on a scale Interval 30.0 to 41.0	35.0 Score on a scale Interval 31.0 to 39.0	34.5 Score on a scale Interval 30.0 to 39.0	0.0 Score on a scale Interval -2.0 to 5.0	-0.5 Score on a scale Interval -2.0 to 9.0
Life Quality Index - 2 to 12 Years Old Therapy-related Problems	23.0 Score on a scale Interval 20.0 to 24.0	23.0 Score on a scale Interval 22.0 to 26.0	22.0 Score on a scale Interval 20.0 to 24.0	21.5 Score on a scale Interval 21.0 to 25.0	0.0 Score on a scale Interval -2.0 to 0.0	-1.0 Score on a scale Interval -3.0 to 0.0
Life Quality Index - 2 to 12 Years Old Therapy Settings	18.0 Score on a scale Interval 17.0 to 21.0	18.0 Score on a scale Interval 16.0 to 20.0	19.0 Score on a scale Interval 18.0 to 21.0	20.0 Score on a scale Interval 17.0 to 21.0	0.0 Score on a scale Interval 0.0 to 3.0	1.0 Score on a scale Interval -1.0 to 3.0
Life Quality Index - 2 to 12 Years Old Costs	9.0 Score on a scale Interval 8.0 to 11.0	11.0 Score on a scale Interval 10.0 to 13.0	11.0 Score on a scale Interval 11.0 to 12.0	10.5 Score on a scale Interval 9.0 to 13.0	1.0 Score on a scale Interval 0.0 to 2.0	-0.5 Score on a scale Interval -1.0 to 2.0

SECONDARY outcome

Timeframe: Up to 20 months per subject (throughout entire study)

Population: Safety Analysis Set - participants aged 13 years and older with data (scores) at relevant time points

For the age group 13 years and older the respondent will be the participant. Each of the four domains has a separate score, each has a different range as follows: Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment.

Outcome measures

Outcome measures
Measure	Study Participants n=61 Participants	Subcutaneous 20% - Epochs 2 Thru 4 n=58 Participants \- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.	SC 20% 145% IV 1 Week n=54 Participants	SC 20% Adjusted 1 Week n=52 Participants	SC 20% Individualized 1 Week n=54 Participants	Change End Epoch 1 to End Epoch 4 n=52 Participants Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Life Quality Index - 13 Years and Older Treatment Interference	34.0 Score on a scale Interval 30.0 to 37.0	34.5 Score on a scale Interval 32.0 to 36.0	37.0 Score on a scale Interval 35.0 to 39.0	38.5 Score on a scale Interval 34.0 to 40.0	1.0 Score on a scale Interval 0.0 to 4.0	3.0 Score on a scale Interval 0.0 to 5.0
Life Quality Index - 13 Years and Older Therapy-related Problems	23.0 Score on a scale Interval 22.0 to 24.0	22.5 Score on a scale Interval 21.0 to 24.0	24.0 Score on a scale Interval 22.0 to 25.0	24.0 Score on a scale Interval 23.0 to 25.0	0.0 Score on a scale Interval -1.0 to 2.0	1.0 Score on a scale Interval -1.0 to 2.0
Life Quality Index - 13 Years and Older Therapy Settings	18.0 Score on a scale Interval 16.0 to 19.0	17.0 Score on a scale Interval 16.0 to 18.0	20.0 Score on a scale Interval 19.0 to 20.0	20.0 Score on a scale Interval 19.0 to 21.0	1.0 Score on a scale Interval 0.0 to 3.0	2.0 Score on a scale Interval 0.0 to 3.0
Life Quality Index - 13 Years and Older Costs	8.0 Score on a scale Interval 7.0 to 10.0	10.0 Score on a scale Interval 9.0 to 10.0	11.5 Score on a scale Interval 10.0 to 13.0	13.0 Score on a scale Interval 11.0 to 14.0	1.0 Score on a scale Interval 0.0 to 2.0	1.5 Score on a scale Interval 1.0 to 3.0

Adverse Events

Study Epoch 1: Intravenous 10% Treatment

Serious events: 1 serious events

Other events: 46 other events

Deaths: 0 deaths

Study Epochs 2-4: Subcutaneous 20% Treatment

Serious events: 2 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Study Epoch 1: Intravenous 10% Treatment n=77 participants at risk	Study Epochs 2-4: Subcutaneous 20% Treatment n=74 participants at risk
Nervous system disorders Headache	1.3% 1/77 • Number of events 1 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	0.00% 0/74 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Infections and infestations Pneumonia	0.00% 0/77 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	1.4% 1/74 • Number of events 1 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinima	0.00% 0/77 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	1.4% 1/74 • Number of events 1 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks

Other adverse events

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Baxalta's agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or ≤15 months after study completion. Baxalta requires a review of results communications (eg, for confidential information) ≥30 days prior to submission or communication. Baxalta may request an additional delay of ≤60 days eg, for intellectual property protection.
Publication restrictions are in place

Restriction type: OTHER

Measure	Study Epoch 1: Intravenous 10% Treatment n=77 participants at risk	Study Epochs 2-4: Subcutaneous 20% Treatment n=74 participants at risk
Infections and infestations Sinusitis	9.1% 7/77 • Number of events 8 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	24.3% 18/74 • Number of events 29 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Infections and infestations Acute sinusitis	7.8% 6/77 • Number of events 8 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	20.3% 15/74 • Number of events 22 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Infections and infestations Upper respiratory tract infection	10.4% 8/77 • Number of events 8 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	18.9% 14/74 • Number of events 21 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
General disorders Infusion site pain	0.00% 0/77 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	18.9% 14/74 • Number of events 34 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Nervous system disorders Headache	29.9% 23/77 • Number of events 44 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	16.2% 12/74 • Number of events 54 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Gastrointestinal disorders Nausea	7.8% 6/77 • Number of events 11 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	14.9% 11/74 • Number of events 21 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Nervous system disorders Bronchitis	3.9% 3/77 • Number of events 3 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	14.9% 11/74 • Number of events 14 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Gastrointestinal disorders Diarrhoea	5.2% 4/77 • Number of events 4 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	10.8% 8/74 • Number of events 11 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Respiratory, thoracic and mediastinal disorders Cough	2.6% 2/77 • Number of events 2 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	10.8% 8/74 • Number of events 9 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
General disorders Infusion site erythema	0.00% 0/77 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	10.8% 8/74 • Number of events 23 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
General disorders Fatigue	6.5% 5/77 • Number of events 6 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	9.5% 7/74 • Number of events 12 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Infections and infestations Nasopharyngitis	5.2% 4/77 • Number of events 4 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	9.5% 7/74 • Number of events 7 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Respiratory, thoracic and mediastinal disorders Asthma	3.9% 3/77 • Number of events 3 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	9.5% 7/74 • Number of events 15 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Gastrointestinal disorders Vomiting	9.1% 7/77 • Number of events 7 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	8.1% 6/74 • Number of events 8 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.3% 1/77 • Number of events 1 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	8.1% 6/74 • Number of events 7 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Psychiatric disorders Insomnia	0.00% 0/77 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	8.1% 6/74 • Number of events 7 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Infections and infestations Viral upper respiratory tract infection	6.5% 5/77 • Number of events 5 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	6.8% 5/74 • Number of events 9 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Infections and infestations Chronic sinusitis	1.3% 1/77 • Number of events 3 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	6.8% 5/74 • Number of events 7 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Infections and infestations Gastroenteritis	1.3% 1/77 • Number of events 1 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	6.8% 5/74 • Number of events 5 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
General disorders Oedema peripheral	0.00% 0/77 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	6.8% 5/74 • Number of events 5 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
General disorders Pyrexia	5.2% 4/77 • Number of events 5 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	5.4% 4/74 • Number of events 8 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.9% 3/77 • Number of events 4 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	5.4% 4/74 • Number of events 4 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Musculoskeletal and connective tissue disorders Myalgia	2.6% 2/77 • Number of events 4 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	5.4% 4/74 • Number of events 6 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Infections and infestations Gastroenteritis viral	2.6% 2/77 • Number of events 2 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	5.4% 4/74 • Number of events 5 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Infections and infestations Pharyngitis	1.3% 1/77 • Number of events 1 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	5.4% 4/74 • Number of events 7 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Nervous system disorders Migraine	1.3% 1/77 • Number of events 4 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	5.4% 4/74 • Number of events 6 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Skin and subcutaneous tissue disorders Rash	1.3% 1/77 • Number of events 1 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	5.4% 4/74 • Number of events 4 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Nervous system disorders Dizziness	0.00% 0/77 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	5.4% 4/74 • Number of events 9 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
General disorders Infusion site pruritus	0.00% 0/77 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	5.4% 4/74 • Number of events 8 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/77 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	5.4% 4/74 • Number of events 5 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks
Nervous system disorders Somnolence	5.2% 4/77 • Number of events 9 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks	2.7% 2/74 • Number of events 3 • Throughout the 4 Study Epochs. Epoch 1: 13 weeks. Epoch 2: 12-16 weeks Epoch 3: 12 weeks Epoch 4: 40 weeks