Trial Outcomes & Findings for Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients (NCT NCT03961009)
NCT ID: NCT03961009
Last Updated: 2025-04-13
Results Overview
Incidence rate was defined as the mean number of acute serious bacterial infections (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) per participant-year according to pre-specified criteria.
COMPLETED
PHASE3
47 participants
Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
2025-04-13
Participant Flow
This study was conducted at 11 sites in the United States from 30 April 2019 (first participant first visit) to 21 December 2020 (last participant last visit).
A total of 59 participants were screened, out of which 47 participants were enrolled and received the treatment in this study.
Participant milestones
| Measure |
Kedrion IVIG 10%
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 milligrams per kilogram (mg/kg) body weight on every 21 or 28 days for period of 48 weeks.
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|---|---|
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Overall Study
STARTED
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47
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Overall Study
COMPLETED
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47
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients
Baseline characteristics by cohort
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
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|---|---|
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Age, Continuous
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52.6 years
STANDARD_DEVIATION 12.90 • n=5 Participants
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Sex: Female, Male
Female
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30 Participants
n=5 Participants
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Sex: Female, Male
Male
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17 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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44 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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45 Participants
n=5 Participants
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Race/Ethnicity, Customized
Mexican
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
White and African American
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: The FAS included all participants who had received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.
Incidence rate was defined as the mean number of acute serious bacterial infections (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) per participant-year according to pre-specified criteria.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
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|---|---|
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Incidence Rate of Acute Serious Bacterial Infections (ABSIs)
21-day dosing schedule
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0.0 infections per participant-year
Standard Deviation 0.0
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Incidence Rate of Acute Serious Bacterial Infections (ABSIs)
28-day dosing schedule
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0.0 infections per participant-year
Standard Deviation 0.0
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SECONDARY outcome
Timeframe: At baseline, Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: FAS included all participants who have received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.
The serum IgG trough levels were collected and analyzed at a central laboratory.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
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|---|---|
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Serum Immunoglobulin G (IgG) Trough Levels
Baseline
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10.317 grams per liter (g/L)
Standard Deviation 3.1342
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Serum Immunoglobulin G (IgG) Trough Levels
21-day dosing schedule: Week 51
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11.433 grams per liter (g/L)
Standard Deviation 1.7935
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Serum Immunoglobulin G (IgG) Trough Levels
28-day dosing schedule: Week 52
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10.297 grams per liter (g/L)
Standard Deviation 2.1167
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SECONDARY outcome
Timeframe: At baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)Population: FAS included all participants who have received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.
IgG subclasses levels (IgG1, IgG2, IgG3, IgG4) were collected and analyzed at a central laboratory.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
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|---|---|
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG1: 28-day dosing schedule: Week 32
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5.679 g/L
Standard Deviation 1.3965
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG1: 21-day dosing schedule: Week 30
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5.979 g/L
Standard Deviation 0.9430
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG3: 28-day dosing schedule: Week 16
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0.351 g/L
Standard Deviation 0.3459
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG3: 21-day dosing schedule: Week 18
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0.271 g/L
Standard Deviation 0.1239
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG3: 28-day dosing schedule: Week 32
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0.352 g/L
Standard Deviation 0.3461
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG3: 21-day dosing schedule: Week 30
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0.249 g/L
Standard Deviation 0.0885
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG4: 21-day dosing schedule: Week 30
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0.2838 g/L
Standard Deviation 0.06412
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG4: 28-day dosing schedule: Week 48
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0.2396 g/L
Standard Deviation 0.09355
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG4: 21-day dosing schedule: Week 48
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0.2950 g/L
Standard Deviation 0.05381
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG1: Baseline
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5.798 g/L
Standard Deviation 1.7504
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG1: 28-day dosing schedule: Week 16
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5.605 g/L
Standard Deviation 1.6115
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG1: 21-day dosing schedule: Week 18
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5.968 g/L
Standard Deviation 1.5094
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG1: 28-day dosing schedule: Week 48
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5.634 g/L
Standard Deviation 1.4139
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG1: 21-day dosing schedule: Week 48
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6.210 g/L
Standard Deviation 0.9430
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG2: Baseline
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3.527 g/L
Standard Deviation 0.9635
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG2: 28-day dosing schedule: Week 16
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3.419 g/L
Standard Deviation 0.8803
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG2: 21-day dosing schedule: Week 18
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4.113 g/L
Standard Deviation 1.0155
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG2: 28-day dosing schedule: Week 32
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3.458 g/L
Standard Deviation 0.7705
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG2: 21-day dosing schedule: Week 30
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4.079 g/L
Standard Deviation 0.4975
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG2: 28-day dosing schedule: Week 48
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3.475 g/L
Standard Deviation 0.7848
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG2: 21-day dosing schedule: Week 48
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4.234 g/L
Standard Deviation 0.5649
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG3: Baseline
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0.405 g/L
Standard Deviation 0.3109
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG3: 28-day dosing schedule: Week 48
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0.329 g/L
Standard Deviation 0.3268
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG3: 21-day dosing schedule: Week 48
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0.253 g/L
Standard Deviation 0.0658
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG4: Baseline
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0.2213 g/L
Standard Deviation 0.12779
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG4: 28-day dosing schedule: Week 16
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0.2388 g/L
Standard Deviation 0.09656
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG4: 21-day dosing schedule: Week 18
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0.2744 g/L
Standard Deviation 0.06415
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Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG4: 28-day dosing schedule: Week 32
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0.2425 g/L
Standard Deviation 0.09290
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SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: FAS included all participants who have received at least 1 dose of study medication.
Number of participants with Total IgG trough levels \<= 6 g/L criteria were reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
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|---|---|
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Number of Participants With Total Immunoglobulin G (IgG) Trough Levels Less Than or Equal to (<=) 6 Grams/Liter (g/L) Criteria
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1 Participants
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SECONDARY outcome
Timeframe: Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)Population: FAS included all participants who have received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.
The anti-tetanus toxoid antibody levels were collected and analyzed at a central laboratory. This antibody level was measured in international units per milliliter (IU/mL).
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
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|---|---|
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Anti-Tetanus Toxoid Antibody Levels
Baseline
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2.526 IU/mL
Standard Deviation 1.4158
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Anti-Tetanus Toxoid Antibody Levels
28-day dosing schedule: Week 16
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2.589 IU/mL
Standard Deviation 2.0770
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Anti-Tetanus Toxoid Antibody Levels
21-day dosing schedule: Week 18
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2.654 IU/mL
Standard Deviation 0.9853
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Anti-Tetanus Toxoid Antibody Levels
28-day dosing schedule: Week 32
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2.345 IU/mL
Standard Deviation 0.8820
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Anti-Tetanus Toxoid Antibody Levels
21-day dosing schedule: Week 30
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2.643 IU/mL
Standard Deviation 0.9374
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Anti-Tetanus Toxoid Antibody Levels
28-day dosing schedule: Week 48
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2.207 IU/mL
Standard Deviation 0.8565
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Anti-Tetanus Toxoid Antibody Levels
21-day dosing schedule: Week 48
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3.299 IU/mL
Standard Deviation 1.3307
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SECONDARY outcome
Timeframe: Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)Population: FAS included all participants who have received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.
Anti-pneumococcal capsular polysaccharide antibody levels for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 were collected and analyzed at a central laboratory.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 12
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0.75 milligrams per liter (mg/L)
Standard Deviation 1.201
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 17
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3.25 milligrams per liter (mg/L)
Standard Deviation 3.146
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 22
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1.33 milligrams per liter (mg/L)
Standard Deviation 1.968
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 22
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0.84 milligrams per liter (mg/L)
Standard Deviation 0.938
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 22
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2.36 milligrams per liter (mg/L)
Standard Deviation 3.554
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 22
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0.83 milligrams per liter (mg/L)
Standard Deviation 0.698
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 23
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1.37 milligrams per liter (mg/L)
Standard Deviation 2.064
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 3
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4.69 milligrams per liter (mg/L)
Standard Deviation 7.854
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 34
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1.83 milligrams per liter (mg/L)
Standard Deviation 2.663
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 5
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5.41 milligrams per liter (mg/L)
Standard Deviation 7.414
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 51
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2.82 milligrams per liter (mg/L)
Standard Deviation 5.468
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 54
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2.33 milligrams per liter (mg/L)
Standard Deviation 2.575
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 54
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5.04 milligrams per liter (mg/L)
Standard Deviation 6.363
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 56
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2.17 milligrams per liter (mg/L)
Standard Deviation 5.089
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 68
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1.08 milligrams per liter (mg/L)
Standard Deviation 1.095
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 68
|
0.93 milligrams per liter (mg/L)
Standard Deviation 0.918
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 68
|
1.36 milligrams per liter (mg/L)
Standard Deviation 1.260
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 68
|
1.33 milligrams per liter (mg/L)
Standard Deviation 1.233
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 70
|
3.53 milligrams per liter (mg/L)
Standard Deviation 5.776
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 70
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1.48 milligrams per liter (mg/L)
Standard Deviation 0.988
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 43
|
1.08 milligrams per liter (mg/L)
Standard Deviation 0.568
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 19
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3.71 milligrams per liter (mg/L)
Standard Deviation 5.275
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 19
|
4.95 milligrams per liter (mg/L)
Standard Deviation 8.597
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 19
|
3.20 milligrams per liter (mg/L)
Standard Deviation 1.074
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 19
|
3.71 milligrams per liter (mg/L)
Standard Deviation 4.200
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 19
|
2.88 milligrams per liter (mg/L)
Standard Deviation 0.686
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 19
|
4.25 milligrams per liter (mg/L)
Standard Deviation 7.328
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 19
|
2.86 milligrams per liter (mg/L)
Standard Deviation 0.958
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 70
|
1.98 milligrams per liter (mg/L)
Standard Deviation 2.911
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 70
|
1.43 milligrams per liter (mg/L)
Standard Deviation 1.100
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 70
|
3.56 milligrams per liter (mg/L)
Standard Deviation 5.360
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 70
|
1.53 milligrams per liter (mg/L)
Standard Deviation 1.128
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 70
|
3.19 milligrams per liter (mg/L)
Standard Deviation 3.978
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 8
|
2.10 milligrams per liter (mg/L)
Standard Deviation 2.650
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 8
|
1.67 milligrams per liter (mg/L)
Standard Deviation 1.258
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 8
|
3.51 milligrams per liter (mg/L)
Standard Deviation 3.440
|
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 8
|
1.86 milligrams per liter (mg/L)
Standard Deviation 1.822
|
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 8
|
3.66 milligrams per liter (mg/L)
Standard Deviation 4.268
|
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 8
|
1.82 milligrams per liter (mg/L)
Standard Deviation 1.593
|
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 8
|
3.63 milligrams per liter (mg/L)
Standard Deviation 3.479
|
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 9
|
0.96 milligrams per liter (mg/L)
Standard Deviation 0.694
|
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 9
|
0.77 milligrams per liter (mg/L)
Standard Deviation 0.510
|
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Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 9
|
1.03 milligrams per liter (mg/L)
Standard Deviation 0.560
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 9
|
0.81 milligrams per liter (mg/L)
Standard Deviation 0.587
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 9
|
0.99 milligrams per liter (mg/L)
Standard Deviation 0.503
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 9
|
0.75 milligrams per liter (mg/L)
Standard Deviation 0.433
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 9
|
1.03 milligrams per liter (mg/L)
Standard Deviation 0.486
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 1
|
2.66 milligrams per liter (mg/L)
Standard Deviation 4.820
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 1
|
1.55 milligrams per liter (mg/L)
Standard Deviation 1.481
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 1
|
4.89 milligrams per liter (mg/L)
Standard Deviation 5.740
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 1
|
1.66 milligrams per liter (mg/L)
Standard Deviation 2.114
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 1
|
4.74 milligrams per liter (mg/L)
Standard Deviation 5.692
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 1
|
1.49 milligrams per liter (mg/L)
Standard Deviation 1.707
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 1
|
4.28 milligrams per liter (mg/L)
Standard Deviation 4.926
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 12
|
0.81 milligrams per liter (mg/L)
Standard Deviation 1.103
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 12
|
0.58 milligrams per liter (mg/L)
Standard Deviation 0.175
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 12
|
0.86 milligrams per liter (mg/L)
Standard Deviation 1.280
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 12
|
0.55 milligrams per liter (mg/L)
Standard Deviation 0.120
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 12
|
0.82 milligrams per liter (mg/L)
Standard Deviation 1.159
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 12
|
0.59 milligrams per liter (mg/L)
Standard Deviation 0.090
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 14
|
9.04 milligrams per liter (mg/L)
Standard Deviation 20.383
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 14
|
11.88 milligrams per liter (mg/L)
Standard Deviation 29.791
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 14
|
6.11 milligrams per liter (mg/L)
Standard Deviation 3.302
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 14
|
11.96 milligrams per liter (mg/L)
Standard Deviation 26.509
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 14
|
5.76 milligrams per liter (mg/L)
Standard Deviation 2.752
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 14
|
13.02 milligrams per liter (mg/L)
Standard Deviation 34.794
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 14
|
6.14 milligrams per liter (mg/L)
Standard Deviation 3.408
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 17
|
2.55 milligrams per liter (mg/L)
Standard Deviation 4.249
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 17
|
2.08 milligrams per liter (mg/L)
Standard Deviation 3.977
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 17
|
1.89 milligrams per liter (mg/L)
Standard Deviation 2.952
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 17
|
3.38 milligrams per liter (mg/L)
Standard Deviation 4.058
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 17
|
1.76 milligrams per liter (mg/L)
Standard Deviation 3.043
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 17
|
3.09 milligrams per liter (mg/L)
Standard Deviation 3.111
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 2
|
2.38 milligrams per liter (mg/L)
Standard Deviation 2.294
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 2
|
2.04 milligrams per liter (mg/L)
Standard Deviation 1.618
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 2
|
3.34 milligrams per liter (mg/L)
Standard Deviation 3.701
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 2
|
2.11 milligrams per liter (mg/L)
Standard Deviation 1.502
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 2
|
3.48 milligrams per liter (mg/L)
Standard Deviation 4.071
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 2
|
2.01 milligrams per liter (mg/L)
Standard Deviation 1.283
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 2
|
3.35 milligrams per liter (mg/L)
Standard Deviation 3.342
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 20
|
2.71 milligrams per liter (mg/L)
Standard Deviation 2.296
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 20
|
2.63 milligrams per liter (mg/L)
Standard Deviation 3.007
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 20
|
3.05 milligrams per liter (mg/L)
Standard Deviation 1.425
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 20
|
2.76 milligrams per liter (mg/L)
Standard Deviation 3.153
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 20
|
3.16 milligrams per liter (mg/L)
Standard Deviation 1.614
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 20
|
2.51 milligrams per liter (mg/L)
Standard Deviation 2.779
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 20
|
3.05 milligrams per liter (mg/L)
Standard Deviation 1.295
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 22
|
2.78 milligrams per liter (mg/L)
Standard Deviation 4.627
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 22
|
0.88 milligrams per liter (mg/L)
Standard Deviation 0.670
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 22
|
2.51 milligrams per liter (mg/L)
Standard Deviation 3.652
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 23
|
1.65 milligrams per liter (mg/L)
Standard Deviation 2.336
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 23
|
1.42 milligrams per liter (mg/L)
Standard Deviation 2.501
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 23
|
1.28 milligrams per liter (mg/L)
Standard Deviation 0.696
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 23
|
1.34 milligrams per liter (mg/L)
Standard Deviation 0.607
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 23
|
1.47 milligrams per liter (mg/L)
Standard Deviation 2.270
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 23
|
1.50 milligrams per liter (mg/L)
Standard Deviation 0.733
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 26
|
1.72 milligrams per liter (mg/L)
Standard Deviation 1.910
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 26
|
1.32 milligrams per liter (mg/L)
Standard Deviation 1.578
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 26
|
1.83 milligrams per liter (mg/L)
Standard Deviation 2.050
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 26
|
1.36 milligrams per liter (mg/L)
Standard Deviation 1.515
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 26
|
1.70 milligrams per liter (mg/L)
Standard Deviation 1.505
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 26
|
1.39 milligrams per liter (mg/L)
Standard Deviation 1.549
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 26
|
1.73 milligrams per liter (mg/L)
Standard Deviation 1.482
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 3
|
2.41 milligrams per liter (mg/L)
Standard Deviation 5.964
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 3
|
1.41 milligrams per liter (mg/L)
Standard Deviation 2.362
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 3
|
4.74 milligrams per liter (mg/L)
Standard Deviation 7.812
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 3
|
1.42 milligrams per liter (mg/L)
Standard Deviation 2.526
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 3
|
4.24 milligrams per liter (mg/L)
Standard Deviation 6.480
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 3
|
1.12 milligrams per liter (mg/L)
Standard Deviation 1.287
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 34
|
1.34 milligrams per liter (mg/L)
Standard Deviation 1.718
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 34
|
3.33 milligrams per liter (mg/L)
Standard Deviation 4.843
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 34
|
1.30 milligrams per liter (mg/L)
Standard Deviation 1.524
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 34
|
3.73 milligrams per liter (mg/L)
Standard Deviation 6.610
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 34
|
1.35 milligrams per liter (mg/L)
Standard Deviation 1.585
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 34
|
3.04 milligrams per liter (mg/L)
Standard Deviation 4.276
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 4
|
0.88 milligrams per liter (mg/L)
Standard Deviation 1.366
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 4
|
0.54 milligrams per liter (mg/L)
Standard Deviation 0.896
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 4
|
0.57 milligrams per liter (mg/L)
Standard Deviation 0.576
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 4
|
1.07 milligrams per liter (mg/L)
Standard Deviation 1.292
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 4
|
0.66 milligrams per liter (mg/L)
Standard Deviation 0.434
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 4
|
0.89 milligrams per liter (mg/L)
Standard Deviation 1.187
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 4
|
0.68 milligrams per liter (mg/L)
Standard Deviation 0.466
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 43
|
1.36 milligrams per liter (mg/L)
Standard Deviation 0.713
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 43
|
1.07 milligrams per liter (mg/L)
Standard Deviation 0.665
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 43
|
1.51 milligrams per liter (mg/L)
Standard Deviation 0.645
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 43
|
1.43 milligrams per liter (mg/L)
Standard Deviation 0.468
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 43
|
1.12 milligrams per liter (mg/L)
Standard Deviation 0.605
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 43
|
1.61 milligrams per liter (mg/L)
Standard Deviation 0.482
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 5
|
3.64 milligrams per liter (mg/L)
Standard Deviation 5.551
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 5
|
2.68 milligrams per liter (mg/L)
Standard Deviation 3.650
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 5
|
6.56 milligrams per liter (mg/L)
Standard Deviation 9.390
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 5
|
2.65 milligrams per liter (mg/L)
Standard Deviation 3.081
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 5
|
6.51 milligrams per liter (mg/L)
Standard Deviation 10.172
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 5
|
2.44 milligrams per liter (mg/L)
Standard Deviation 3.145
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 51
|
1.66 milligrams per liter (mg/L)
Standard Deviation 0.777
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 51
|
5.96 milligrams per liter (mg/L)
Standard Deviation 8.691
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 51
|
1.65 milligrams per liter (mg/L)
Standard Deviation 0.786
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 51
|
5.70 milligrams per liter (mg/L)
Standard Deviation 7.914
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 51
|
1.58 milligrams per liter (mg/L)
Standard Deviation 0.843
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 51
|
5.86 milligrams per liter (mg/L)
Standard Deviation 8.456
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 54
|
3.04 milligrams per liter (mg/L)
Standard Deviation 4.819
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 54
|
2.95 milligrams per liter (mg/L)
Standard Deviation 5.542
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 54
|
4.86 milligrams per liter (mg/L)
Standard Deviation 5.637
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 54
|
2.53 milligrams per liter (mg/L)
Standard Deviation 3.181
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 54
|
4.13 milligrams per liter (mg/L)
Standard Deviation 3.700
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 56
|
3.41 milligrams per liter (mg/L)
Standard Deviation 8.495
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 56
|
2.55 milligrams per liter (mg/L)
Standard Deviation 6.989
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 56
|
5.84 milligrams per liter (mg/L)
Standard Deviation 9.970
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 56
|
5.38 milligrams per liter (mg/L)
Standard Deviation 8.242
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 56
|
2.54 milligrams per liter (mg/L)
Standard Deviation 8.116
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 56
|
6.00 milligrams per liter (mg/L)
Standard Deviation 10.338
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Baseline: Serotype 57
|
5.73 milligrams per liter (mg/L)
Standard Deviation 8.398
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 57
|
5.11 milligrams per liter (mg/L)
Standard Deviation 8.435
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 57
|
23.40 milligrams per liter (mg/L)
Standard Deviation 48.403
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 32: Serotype 57
|
5.46 milligrams per liter (mg/L)
Standard Deviation 9.059
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 30: Serotype 57
|
7.00 milligrams per liter (mg/L)
Standard Deviation 10.268
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 57
|
5.31 milligrams per liter (mg/L)
Standard Deviation 9.379
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 48: Serotype 57
|
8.17 milligrams per liter (mg/L)
Standard Deviation 12.789
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 16: Serotype 68
|
0.86 milligrams per liter (mg/L)
Standard Deviation 0.567
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
21-day dosing schedule: Week 18: Serotype 68
|
1.66 milligrams per liter (mg/L)
Standard Deviation 1.555
|
|
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
28-day dosing schedule: Week 48: Serotype 68
|
0.76 milligrams per liter (mg/L)
Standard Deviation 0.524
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)Population: As per change in planned analysis, the anti-measles antibody level test was not performed.
The anti-measles antibody levels were collected and analyzed at a central laboratory.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 32 and 48 (28 -day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)Population: FAS included all participants who had received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.
The anti-haemophilus influenza type B antibody levels were collected and analyzed at central laboratory.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Anti-Haemophilus Influenza Type B Antibody Levels
Baseline
|
2.010 micrograms per milliliter (mcg/mL)
Standard Deviation 1.1641
|
|
Anti-Haemophilus Influenza Type B Antibody Levels
28-day dosing schedule: Week 16
|
2.547 micrograms per milliliter (mcg/mL)
Standard Deviation 1.7879
|
|
Anti-Haemophilus Influenza Type B Antibody Levels
21-day dosing schedule: Week 18
|
2.489 micrograms per milliliter (mcg/mL)
Standard Deviation 0.9027
|
|
Anti-Haemophilus Influenza Type B Antibody Levels
28-day dosing schedule: Week 32
|
2.277 micrograms per milliliter (mcg/mL)
Standard Deviation 1.3112
|
|
Anti-Haemophilus Influenza Type B Antibody Levels
21-day dosing schedule: Week 30
|
2.888 micrograms per milliliter (mcg/mL)
Standard Deviation 0.8676
|
|
Anti-Haemophilus Influenza Type B Antibody Levels
28-day dosing schedule: Week 48
|
2.183 micrograms per milliliter (mcg/mL)
Standard Deviation 1.1944
|
|
Anti-Haemophilus Influenza Type B Antibody Levels
21-day dosing schedule: Week 48
|
2.606 micrograms per milliliter (mcg/mL)
Standard Deviation 0.8433
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: FAS included all participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Incidence rate was defined as the mean number of any infection other than acute serious bacterial infections (bacterial pneumonia, bacteraemia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) per participant-year. Incidence rate of any infection other than acute bacterial serious infections collected by the participant/participants parent(s)/legal guardian(s) in the participant diary or during clinic visit was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Incidence Rate of Any Infection Other Than Acute Serious Bacterial Infections
21-day dosing schedule
|
4.2 infections per participant year
Standard Deviation 2.05
|
|
Incidence Rate of Any Infection Other Than Acute Serious Bacterial Infections
28-day dosing schedule
|
1.6 infections per participant year
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: FAS included all participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Duration of any infection other than serious acute bacterial infections (in days) was calculated as date of stop of infection - date of start of infection + 1. Duration of any infection other than serious acute bacterial infections collected by the by the participant/participants parent(s)/legal guardian(s) in the participant diary or during clinic visit was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Duration of Any Infection Other Than Acute Serious Bacterial Infections
21-day dosing schedule
|
42.9 days
Standard Deviation 66.66
|
|
Duration of Any Infection Other Than Acute Serious Bacterial Infections
28-day dosing schedule
|
25.3 days
Standard Deviation 52.14
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: FAS included all participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Incidence rate was defined as the mean number of fever episodes per participant-year. Incidence rate of fever episodes collected by the participant/participant's parent(s)/legal guardian(s) in the participant diary or during clinic visit were reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Incidence Rate of Fever Episodes
21-day dosing schedule
|
0.0 fever episodes per participant year
Standard Deviation 0.0
|
|
Incidence Rate of Fever Episodes
28-day dosing schedule
|
0.2 fever episodes per participant year
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: FAS included all participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who had fever episodes and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Duration of fever episodes in participants was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=7 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Duration of Fever Episodes in Participants
28-day dosing schedule
|
3.0 days
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: FAS included all participants who received at least 1 dose of study. Here, "Overall Number of Participants Analyzed" signifies those participants who were hospitalized and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Duration of overall participants hospitalization was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=4 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Duration of Overall Participants Hospitalization
21-day dosing schedule
|
6.0 days
|
|
Duration of Overall Participants Hospitalization
28-day dosing schedule
|
3.3 days
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: FAS included all participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who were hospitalized due to infection.
Duration of participants hospitalization due to infection was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: FAS included all participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Incidence rate was defined as the mean number of antibiotics episodes per participant year. Incidence rate of participants on antibiotics for treatment of any kind of infections was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Incidence Rate of Antibiotics Episodes for Treatment of Any Kind of Infections
21-day dosing schedule
|
3.8 antibiotics episodes/participant year
Standard Deviation 1.95
|
|
Incidence Rate of Antibiotics Episodes for Treatment of Any Kind of Infections
28-day dosing schedule
|
2.1 antibiotics episodes/participant year
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: FAS included all participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who took antibiotics to treat infections and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Duration of participants on antibiotics for treatment of any kind of infection was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=36 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Duration of Participants on Antibiotics for Treatment of Any Kind of Infection
21-day dosing schedule
|
13.1 days
Standard Deviation 5.72
|
|
Duration of Participants on Antibiotics for Treatment of Any Kind of Infection
28-day dosing schedule
|
13.3 days
Standard Deviation 35.86
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: FAS included all participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who had missed school/work/other major activities due to infections and, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Duration of missed school/work/other major activities due to infections was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=9 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Duration of Missed School/Work/Other Major Activities Due to Infections
21-day dosing schedule
|
25.3 days
Standard Deviation 25.11
|
|
Duration of Missed School/Work/Other Major Activities Due to Infections
28-day dosing schedule
|
4.7 days
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: Baseline, Week 24 (21-day dosing schedule and 28-day dosing schedule), Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: The FAS included all participants who received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
23-item PedsQL generic core scales was a modular approach to measure health-related Quality of Life (QoL) in healthy children, adolescents and those with acute and chronic health conditions. The total scale score (23 items) consisted of Physical Health Summary Score (8 items) and Psychosocial Health SummaryScore (15 items). Physical health summary included Physical Functioning (8 items) and Psychosocial health summary score included Emotional Functioning (5 items), Social Functioning (5 items) and School Functioning (5 items). Items were scored on a 5 point Likert-type response scale: 0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; and 4=almost always a problem). Once scored, items were reverse scored and linearly transformed to a 0-100 scale, where higher scores indicated better QoL. The overall range for total PedsQL score (23 items) was 0 to 100, with higher score indicated better QoL. Data for 18-25 years and \>25 years age group was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Pediatric Quality of Life Inventory (PedsQL) Score
Baseline (18 to 25 years)
|
87.5 score on a scale
Standard Deviation 16.14
|
|
Pediatric Quality of Life Inventory (PedsQL) Score
21-day dosing schedule: Week 24 (18 to 25 years)
|
68.5 score on a scale
|
|
Pediatric Quality of Life Inventory (PedsQL) Score
21-day dosing schedule: Week 51 (18 to 25 years)
|
58.7 score on a scale
|
|
Pediatric Quality of Life Inventory (PedsQL) Score
28-day dosing schedule: Week 24 (18 to 25 years)
|
100.0 score on a scale
|
|
Pediatric Quality of Life Inventory (PedsQL) Score
28-day dosing schedule: Week 52 (18 to 25 years)
|
100.0 score on a scale
|
|
Pediatric Quality of Life Inventory (PedsQL) Score
Baseline (> 25 years)
|
76.2 score on a scale
Standard Deviation 16.53
|
|
Pediatric Quality of Life Inventory (PedsQL) Score
21-day dosing schedule: Week 24 (> 25 years)
|
65.1 score on a scale
Standard Deviation 15.92
|
|
Pediatric Quality of Life Inventory (PedsQL) Score
21-day dosing schedule: Week 51 (> 25 years)
|
70.3 score on a scale
Standard Deviation 18.93
|
|
Pediatric Quality of Life Inventory (PedsQL) Score
28-day dosing schedule: Week 24 (> 25 years)
|
78.3 score on a scale
Standard Deviation 17.02
|
|
Pediatric Quality of Life Inventory (PedsQL) Score
28-day dosing schedule: Week 52 (> 25 years)
|
77.8 score on a scale
Standard Deviation 18.42
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: The SAF included all participants who had received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAE was defined as an AE with an onset that occurs after receiving study drug. Any TEAE included participants with both serious and non-serious TEAEs.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with TEAEs: 21-day dosing schedule:
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with TEAEs: 28-day dosing schedule
|
38 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with Serious TEAEs: 21-day dosing schedule
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with Serious TEAEs: 28-day dosing schedule
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: The SAF included all participants who had received at least 1 dose of study medication. "Overall Number of Participants Analyzed" signifies those participants who had TEAEs and "Number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. A SAE was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. A TEAE was defined as an AE with an onset that occurs after receiving study drug. Number of TEAEs and Serious TEAEs were reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=46 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Number of TEAEs and Serious TEAEs
TEAEs: 21-day dosing schedule
|
79 adverse events
|
|
Number of TEAEs and Serious TEAEs
TEAEs: 28-day dosing schedule
|
324 adverse events
|
|
Number of TEAEs and Serious TEAEs
Serious TEAEs: 21-day dosing schedule
|
1 adverse events
|
|
Number of TEAEs and Serious TEAEs
Serious TEAEs: 28-day dosing schedule
|
4 adverse events
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: The SAF included all participants who have received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who had drug related infusion AEs and "Number Anlyazed" signifies those who were evaluable at specified time points as per dosing schedule.
An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Number of drug related infusion AEs were reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=19 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Number of Drug Related Infusion Adverse Events (AEs)
21-day dosing schedule
|
3 adverse events
|
|
Number of Drug Related Infusion Adverse Events (AEs)
28-day dosing schedule
|
60 adverse events
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: The SAF included all participants who have received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.
Percentage of participants who experienced at least one drug related infusion AEs were reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Percentage of Participants Who Experienced at Least One Drug Related Infusion Adverse Events (AEs)
21-day dosing schedule
|
25.0 percentage of participants
|
|
Percentage of Participants Who Experienced at Least One Drug Related Infusion Adverse Events (AEs)
28-day dosing schedule
|
43.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: The SAF included all participants who have received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.
Number of infusions with decreased infusion rate due to AEs were reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=643 Infusions
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Number of Infusions With Decreased Infusion Rate Due to Adverse Events (AEs)
21-day dosing schedule
|
0 Infusions
|
|
Number of Infusions With Decreased Infusion Rate Due to Adverse Events (AEs)
28-day dosing schedule
|
9 Infusions
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: The SAF included all participants who have received at least 1 dose of study medication.
The number of infusions with one or more infusion associated AEs were reported collectively for 21 and 28-day dosing schedule up to Week 52.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=643 Infusions
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Number of Infusions With One or More Infusion Associated Adverse Events (AEs)
|
80 Infusions
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: SAF included all participants who have received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.
Vital signs included body temperature, systolic and diastolic blood pressure, heart rate and weight. The systolic and diastolic blood pressure and pulse rate was measured after the participants have in a rested at least 3 minutes in seated position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in vital signs were reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
21-day dosing schedule
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
28-day dosing schedule
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: The SAF included all participants who have received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.
Physical examination included the examination of general appearance, skin, neck, eyes, ears, nose, throat, cardiovascular assessment including rhythm, and presence of other cardiac abnormalities (for example gallops, murmurs, cardiomegaly), respiratory system, gastrointestinal system, genitourinary system and musculoskeletal system. Clinical significance was decided by the investigator. The number of participants with clinically significant changes from baseline in physical examination were reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Examinations
21-day dosing schedule
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Examinations
28-day dosing schedule
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)Population: The SAF included all participants who have received at least 1 dose of study medication. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per the dosing schedule.
Laboratory parameters included chemistry, hematology and urinalysis. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in laboratory parameters were reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
Hematology: 21-day dosing schedule
|
3 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
Hematology: 28-day dosing schedule
|
7 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
Chemistry: 21-day dosing schedule
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
Chemistry: 28-day dosing schedule
|
5 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
Urinalysis: 21-day dosing schedule
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
Urinalysis: 28-day dosing schedule
|
4 Participants
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)Population: SAF included all participants who have received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies those participants with Coombs Test and "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Intravascular hemolysis testing was performed by using coomb's test. The coomb's assessment was performed at a central laboratory.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=46 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Number of Participants With Positive Coomb's Test at Week 16 (28-day Dosing Schedule) and Week 18 (21-day Dosing Schedule)
28-day dosing schedule: Week 16
|
14 Participants
|
|
Number of Participants With Positive Coomb's Test at Week 16 (28-day Dosing Schedule) and Week 18 (21-day Dosing Schedule)
21-day dosing schedule: Week 18
|
4 Participants
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)Population: The FAS included all participants who received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Number of participants with positive urine hemosiderin test were reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Number of Participants With Positive Urine Hemosiderin Test
28-day dosing schedule: Week 16
|
0 Participants
|
|
Number of Participants With Positive Urine Hemosiderin Test
21-day dosing schedule: Week 18
|
0 Participants
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)Population: The FAS included all participants who received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Number of participants with plasma-free haemoglobin level more than or equal to (\>=) 69 milligrams per deciliter (mg/dL) were consisdered as abormal and were reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Number of Participants With Abnormal Plasma-free Haemoglobin Level
28-day dosing schedule: Week 16
|
10 Participants
|
|
Number of Participants With Abnormal Plasma-free Haemoglobin Level
21-day dosing schedule : Week 18
|
2 Participants
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)Population: The FAS included all participants who received at least 1 dose of study medication. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Number of participants with abnormal serum haptoglobin level were reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=47 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Number of Participants With Abnormal Serum Haptoglobin Level
28-day dosing schedule: Week 16
|
10 Participants
|
|
Number of Participants With Abnormal Serum Haptoglobin Level
21-day dosing schedule: Week 18
|
0 Participants
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: Pharmacokinetic (PK) Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule)/7th infusion (21-day infusion schedule). This set included all participants following principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Cmax was obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Total Immunoglobulin G (IgG)
Baseline corrected: 28-day dosing schedule: Week 16
|
1280 milligrams per deciliter (mg/dL)
Standard Deviation 433
|
|
Maximum Observed Serum Concentration (Cmax) of Total Immunoglobulin G (IgG)
Baseline corrected: 21-day dosing schedule: Week 18
|
1520 milligrams per deciliter (mg/dL)
Standard Deviation 185
|
|
Maximum Observed Serum Concentration (Cmax) of Total Immunoglobulin G (IgG)
Baseline uncorrected: 28-day dosing schedule: Week 16
|
2300 milligrams per deciliter (mg/dL)
Standard Deviation 466
|
|
Maximum Observed Serum Concentration (Cmax) of Total Immunoglobulin G (IgG)
Baseline uncorrected: 21-day dosing schedule: Week 18
|
2680 milligrams per deciliter (mg/dL)
Standard Deviation 282
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Elimination Half-Life (t1/2) of Total IgG
Baseline corrected: 28-day dosing schedule: Week 16
|
158 hours
Standard Deviation 48.4
|
|
Elimination Half-Life (t1/2) of Total IgG
Baseline corrected: 21-day dosing schedule: Week 18
|
107 hours
Standard Deviation 45.4
|
|
Elimination Half-Life (t1/2) of Total IgG
Baseline uncorrected: 28-day dosing schedule: Week 16
|
896 hours
Standard Deviation 269
|
|
Elimination Half-Life (t1/2) of Total IgG
Baseline uncorrected: 21-day dosing schedule: Week 18
|
587 hours
Standard Deviation 58.2
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. Both baseline corrected and un-corrected data was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Total IgG
Baseline corrected: 28-day dosing schedule: Week 16
|
9520 day*milligram per deciliter (day*mg/dL)
Standard Deviation 3310
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Total IgG
Baseline corrected: 21-day dosing schedule: Week 18
|
8380 day*milligram per deciliter (day*mg/dL)
Standard Deviation 1670
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Total IgG
Baseline uncorrected: 28-day dosing schedule: Week 16
|
37300 day*milligram per deciliter (day*mg/dL)
Standard Deviation 7720
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Total IgG
Baseline uncorrected: 21-day dosing schedule: Week 18
|
31700 day*milligram per deciliter (day*mg/dL)
Standard Deviation 6030
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=22 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total IgG
Baseline corrected: 28-day dosing schedule: Week 16
|
2710.991 hr*g/L
Standard Deviation 733.1555
|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total IgG
Baseline corrected: 21-day dosing schedule: Week 18
|
2435.562 hr*g/L
Standard Deviation 471.842
|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total IgG
Baseline uncorrected: 28-day dosing schedule: Week 16
|
22065.3148 hr*g/L
Standard Deviation 5061.15798
|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total IgG
Baseline uncorrected: 21-day dosing schedule: Week 18
|
18292.68 hr*g/L
Standard Deviation 2869.244
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule. Both baseline corrected and un-corrected data was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Total IgG
Baseline corrected: 28-day dosing schedule: Week 16
|
9840 day*mg/dL
Standard Deviation 3330
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Total IgG
Baseline corrected: 21-day dosing schedule: Week 18
|
8860 day*mg/dL
Standard Deviation 1630
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Total IgG
Baseline uncorrected: 28-day dosing schedule: Week 16
|
38000 day*mg/dL
Standard Deviation 6500
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Total IgG
Baseline uncorrected: 21-day dosing schedule: Week 18
|
34000 day*mg/dL
Standard Deviation 3630
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Vd was defined as the the theoretical volume in which the total amount of total IgG would need to be uniformly distributed to produce the desired blood concentration of a total IgG. Both baseline corrected and un-corrected data was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Volume of Distribution (Vd) of Total IgG
Baseline corrected: 28-day dosing schedule: Week 16
|
0.532 deciliters per kilogram (dL/kg)
Standard Deviation 0.108
|
|
Volume of Distribution (Vd) of Total IgG
Baseline corrected: 21-day dosing schedule: Week 18
|
0.563 deciliters per kilogram (dL/kg)
Standard Deviation 0.161
|
|
Volume of Distribution (Vd) of Total IgG
Baseline uncorrected: 28-day dosing schedule: Week 16
|
0.697 deciliters per kilogram (dL/kg)
Standard Deviation 0.118
|
|
Volume of Distribution (Vd) of Total IgG
Baseline uncorrected: 21-day dosing schedule: Week 18
|
0.667 deciliters per kilogram (dL/kg)
Standard Deviation 0.0398
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Clearance of a total IgG was a measure of the rate at which a total IgG is metabolized or eliminated by normal biological processes. CLss of total IgG was measured in milliliters per hour per kilogram (mL/hr/kg). Both baseline corrected and un-corrected data was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Steady State Clearance (CLss) of Total IgG
Baseline corrected: 28-day dosing schedule: Week 16
|
0.0559 dL/day/kg
Standard Deviation 0.0102
|
|
Steady State Clearance (CLss) of Total IgG
Baseline corrected: 21-day dosing schedule: Week 18
|
0.0763 dL/day/kg
Standard Deviation 0.00342
|
|
Steady State Clearance (CLss) of Total IgG
Baseline uncorrected: 28-day dosing schedule: Week 16
|
0.0140 dL/day/kg
Standard Deviation 0.00355
|
|
Steady State Clearance (CLss) of Total IgG
Baseline uncorrected: 21-day dosing schedule: Week 18
|
0.0193 dL/day/kg
Standard Deviation 0.00305
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Minimum Observed Serum Concentration (Cmin) of Total IgG
Baseline corrected: 28-day dosing schedule: Week 16
|
0.00 mg/dL
Standard Deviation 0.00
|
|
Minimum Observed Serum Concentration (Cmin) of Total IgG
Baseline corrected: 21-day dosing schedule: Week 18
|
0.00 mg/dL
Standard Deviation 0.00
|
|
Minimum Observed Serum Concentration (Cmin) of Total IgG
Baseline uncorrected: 28-day dosing schedule: Week 16
|
994 mg/dL
Standard Deviation 200
|
|
Minimum Observed Serum Concentration (Cmin) of Total IgG
Baseline uncorrected: 21-day dosing schedule: Week 18
|
1140 mg/dL
Standard Deviation 150
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Tmax was obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Total IgG
Baseline corrected: 28-day dosing schedule: Week 16
|
0.515 hours
Interval 0.5 to 23.8
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Total IgG
Baseline corrected: 21-day dosing schedule: Week 18
|
0.530 hours
Interval 0.5 to 2.02
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Total IgG
Baseline uncorrected: 28-day dosing schedule: Week 16
|
0.515 hours
Interval 0.5 to 23.8
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Total IgG
Baseline uncorrected: 21-day dosing schedule: Week 18
|
0.530 hours
Interval 0.5 to 2.02
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Elimination Rate Constant (Kel) of Total IgG
Baseline corrected: 28-day dosing schedule: Week 16
|
0.0048 1/hour
Standard Deviation 0.00156
|
|
Elimination Rate Constant (Kel) of Total IgG
Baseline corrected: 21-day dosing schedule: Week 18
|
0.00743 1/hour
Standard Deviation 0.00300
|
|
Elimination Rate Constant (Kel) of Total IgG
Baseline uncorrected: 28-day dosing schedule: Week 16
|
0.000845 1/hour
Standard Deviation 0.000270
|
|
Elimination Rate Constant (Kel) of Total IgG
Baseline uncorrected: 21-day dosing schedule: Week 18
|
0.00119 1/hour
Standard Deviation 0.000117
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule)/7th infusion (21-day infusion schedule). This set included all participants following principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Average concentration of total IgG over the dosing interval (Cavg) was reported. Both baseline corrected and un-corrected data was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Average Concentration of Total IgG Over the Dosing Interval (Cavg)
Baseline corrected: 28-day dosing schedule: Week 16
|
354 mg/dL
Standard Deviation 117
|
|
Average Concentration of Total IgG Over the Dosing Interval (Cavg)
Baseline corrected: 21-day dosing schedule: Week 18
|
424 mg/dL
Standard Deviation 78.6
|
|
Average Concentration of Total IgG Over the Dosing Interval (Cavg)
Baseline uncorrected: 28-day dosing schedule: Week 16
|
1370 mg/dL
Standard Deviation 239
|
|
Average Concentration of Total IgG Over the Dosing Interval (Cavg)
Baseline uncorrected: 21-day dosing schedule: Week 18
|
1630 mg/dL
Standard Deviation 175
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
The peak trough fluctuation within complete dosing interval at steady state of total IgG was reported. Both baseline corrected and un-corrected data was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Percentage Peak Trough Fluctuation of Total IgG
Baseline corrected: 28-day dosing schedule: Week 16
|
364 percent fluctuation
Standard Deviation 70.7
|
|
Percentage Peak Trough Fluctuation of Total IgG
Baseline corrected: 21-day dosing schedule: Week 18
|
360 percent fluctuation
Standard Deviation 56.3
|
|
Percentage Peak Trough Fluctuation of Total IgG
Baseline uncorrected: 28-day dosing schedule: Week 16
|
94.3 percent fluctuation
Standard Deviation 30.6
|
|
Percentage Peak Trough Fluctuation of Total IgG
Baseline uncorrected: 21-day dosing schedule: Week 18
|
95.0 percent fluctuation
Standard Deviation 7.92
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Cmax was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Tetanus Toxoid Antibodies
28-day dosing schedule: Week 16
|
6.533 IU/mL
Standard Deviation 2.9955
|
|
Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Tetanus Toxoid Antibodies
21-day dosing schedule: Week 18
|
7.400 IU/mL
Standard Deviation 2.0988
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=21 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Elimination Half-Life (t1/2) of Antigen-Specific Tetanus Toxoid Antibodies
28-day dosing schedule: Week 16
|
618.97 hours
Standard Deviation 320.008
|
|
Elimination Half-Life (t1/2) of Antigen-Specific Tetanus Toxoid Antibodies
21-day dosing schedule: Week 18
|
1097.75 hours
Standard Deviation 1061.343
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. The AUC0-t of antigen-specific tetanus toxoid antibodies was measured in hour\*international units per milliliter (hr\*IU/mL).
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Tetanus Toxoid Antibodies
28-day dosing schedule: Week 16
|
2037.7497 hr*IU/mL
Standard Deviation 568.85079
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Tetanus Toxoid Antibodies
21-day dosing schedule: Week 18
|
1805.9758 hr*IU/mL
Standard Deviation 210.37005
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=21 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Tetanus Toxoid Antibodies
28-day dosing schedule: Week 16
|
4171.4977 hour*microgram per milliliter(hr*mcg/mL)
Standard Deviation 2513.60199
|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Tetanus Toxoid Antibodies
21-day dosing schedule: Week 18
|
10142.0162 hour*microgram per milliliter(hr*mcg/mL)
Standard Deviation 12855.54687
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=21 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Tetanus Toxoid Antibodies
28-day dosing schedule: Week 16
|
1997.8829 hr*IU/mL
Standard Deviation 526.07254
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Tetanus Toxoid Antibodies
21-day dosing schedule: Week 18
|
1934.6533 hr*IU/mL
Standard Deviation 317.07241
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Vd was defined as the the theoretical volume in which the total amount of antigen-specific tetanus toxoid antibodies would need to be uniformly distributed to produce the desired blood concentration of antigen-specific tetanus toxoid antibodies. The Vd of antigen-specific tetanus toxoid antibodies was measured in milligrams\*milliliter per international unit\*kilogram (mg\*mL/IU\*kg).
Outcome measures
| Measure |
Kedrion IVIG 10%
n=21 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Volume of Distribution (Vd) of Antigen-Specific Tetanus Toxoid Antibodies
28-day dosing schedule: Week 16
|
263.3132 mg*mL/IU*kg
Standard Deviation 157.80776
|
|
Volume of Distribution (Vd) of Antigen-Specific Tetanus Toxoid Antibodies
21-day dosing schedule: Week 18
|
688.4792 mg*mL/IU*kg
Standard Deviation 792.01235
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Clearance of a antigen-specific tetanus toxoid antibodies was a measure of the rate at which a antigen-specific tetanus toxoid antibodies are metabolized or eliminated by normal biological processes. The CLss of antigen-specific tetanus toxoid antibodies was reported. The CLss of antigen-specific tetanus toxoid antibodies was measured in milligrams\*milliliter per hour\*international unit\*kilogram (mg\*mL/hr\*IU\*kg).
Outcome measures
| Measure |
Kedrion IVIG 10%
n=21 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Steady State Clearance (CLss) of Antigen-Specific Tetanus Toxoid Antibodies
28-day dosing schedule: Week 16
|
0.2741 mg*mL/hr*IU*kg
Standard Deviation 0.06916
|
|
Steady State Clearance (CLss) of Antigen-Specific Tetanus Toxoid Antibodies
21-day dosing schedule: Week 18
|
0.3724 mg*mL/hr*IU*kg
Standard Deviation 0.05201
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Tetanus Toxoid Antibodies
28-day dosing schedule: Week 16
|
1.833 IU/mL
Standard Deviation 0.5531
|
|
Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Tetanus Toxoid Antibodies
21-day dosing schedule: Week 18
|
2.240 IU/mL
Standard Deviation 0.4827
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Tmax was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Tetanus Toxoid Antibodies
28-day dosing schedule: Week 16
|
2.000 hours
Interval 0.48 to 168.0
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Tetanus Toxoid Antibodies
21-day dosing schedule: Week 18
|
70.450 hours
Interval 1.97 to 71.25
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=11 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Elimination Rate Constant (Kel) of Antigen-Specific Tetanus Toxoid Antibodies
28-day dosing schedule: Week 16
|
0.0014 1/hour
Standard Deviation 0.00062
|
|
Elimination Rate Constant (Kel) of Antigen-Specific Tetanus Toxoid Antibodies
21-day dosing schedule: Week 18
|
0.0011 1/hour
Standard Deviation 0.00065
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Average concentration of antigen-specific tetanus toxoid antibodies over the dosing interval (Cavg) was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=21 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Average Concentration of Antigen-Specific Tetanus Toxoid Antibodies Over the Dosing Interval (Cavg)
28-day dosing schedule: Week 16
|
2.9730 IU/mL
Standard Deviation 0.78285
|
|
Average Concentration of Antigen-Specific Tetanus Toxoid Antibodies Over the Dosing Interval (Cavg)
21-day dosing schedule: Week 18
|
3.8386 IU/mL
Standard Deviation 0.62911
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
The peak trough fluctuation within complete dosing interval at steady state of antigen-specific tetanus toxoid antibodies was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=21 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Percentage Peak Trough Fluctuation of Antigen-Specific Tetanus Toxoid Antibodies
28-day dosing schedule: Week 16
|
154.7237 percent fluctuation
Standard Deviation 63.56527
|
|
Percentage Peak Trough Fluctuation of Antigen-Specific Tetanus Toxoid Antibodies
21-day dosing schedule: Week 18
|
145.9127 percent fluctuation
Standard Deviation 55.92179
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Cmax was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=22 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies
28-day dosing schedule: Week 16
|
0.682 milligram per deciliter (mg/dL)
Standard Deviation 0.204
|
|
Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies
21-day dosing schedule: Week 18
|
0.787 milligram per deciliter (mg/dL)
Standard Deviation 0.141
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time pointsas per dosing schedule.
t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=15 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Elimination Half-Life (t1/2) of Antigen-Specific Haemophilus Influenza Type B Antibodies
28-day dosing schedule: Week 16
|
682 hours
Standard Deviation 488
|
|
Elimination Half-Life (t1/2) of Antigen-Specific Haemophilus Influenza Type B Antibodies
21-day dosing schedule: Week 18
|
364 hours
Standard Deviation 52.2
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. AUC0-t of antigen-specific haemophilus influenza Type B Antibodies was measured in hour\*microgram per milliliter (hr\*mcg/mL).
Outcome measures
| Measure |
Kedrion IVIG 10%
n=22 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Haemophilus Influenza Type B Antibodies
28-day dosing schedule: Week 16
|
9.80 day*mg/dL
Standard Deviation 4.35
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Haemophilus Influenza Type B Antibodies
21-day dosing schedule: Week 18
|
8.80 day*mg/dL
Standard Deviation 3.02
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=20 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Haemophilus Influenza Type B Antibodies
28-day dosing schedule: Week 16
|
5087.4141 hr*mcg/mL
Standard Deviation 3563.09258
|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Haemophilus Influenza Type B Antibodies
21-day dosing schedule: Week 18
|
4223.1698 hr*mcg/mL
Standard Deviation 493.35835
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=21 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Haemophilus Influenza Type B Antibodies
28-day dosing schedule: Week 16
|
9.80 day*mg/dL
Standard Deviation 4.35
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Haemophilus Influenza Type B Antibodies
21-day dosing schedule: Week 18
|
9.90 day*mg/dL
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Vd was defined as the the theoretical volume in which the total amount of antigen-specific haemophilus influenza type B antibodies would need to be uniformly distributed to produce the desired blood concentration of a antigen-specific haemophilus influenza type B antibodies.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=20 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Volume of Distribution (Vd) of Antigen-Specific Haemophilus Influenza Type B Antibodies
28-day dosing schedule: Week 16
|
245966.4231 milligrams per kilogram (mL/kg)
Standard Deviation 160457.69395
|
|
Volume of Distribution (Vd) of Antigen-Specific Haemophilus Influenza Type B Antibodies
21-day dosing schedule: Week 18
|
182273.0408 milligrams per kilogram (mL/kg)
Standard Deviation 88143.84190
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Clearance of antigen-specific haemophilus influenza type B antibodies was a measure of the rate at which antigen-specific haemophilus influenza type B antibodies were metabolized or eliminated by normal biological processes. CLss of antigen-specific haemophilus influenza type B antibodies was measured in milliliter per hour per kilogram (mL/hr/kg).
Outcome measures
| Measure |
Kedrion IVIG 10%
n=20 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Steady State Clearance (CLss) of Antigen-Specific Haemophilus Influenza Type B Antibodies
28-day dosing schedule: Week 16
|
253.5539 mL/hr/kg
Standard Deviation 75.88763
|
|
Steady State Clearance (CLss) of Antigen-Specific Haemophilus Influenza Type B Antibodies
21-day dosing schedule: Week 18
|
299.5030 mL/hr/kg
Standard Deviation 100.44087
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=22 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Haemophilus Influenza Type B Antibodies
28-day dosing schedule: Week 16
|
0.215 mg/dL
Standard Deviation 0.134
|
|
Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Haemophilus Influenza Type B Antibodies
21-day dosing schedule: Week 18
|
0.225 mg/dL
Standard Deviation 0.0623
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Tmax was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=22 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies
28-day dosing schedule: Week 16
|
0.500 hours
Interval 0.48 to 24.3
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies
21-day dosing schedule: Week 18
|
2.02 hours
Interval 0.5 to 502.0
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Terminal Elimination Rate Constant (lambda z) derived if data allowed based on PK acceptance criteria
Outcome measures
| Measure |
Kedrion IVIG 10%
n=15 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Terminal Elimination Rate Constant (Lambda z) of Antigen-Specific Haemophilus Influenza Type B Antibodies
28-day dosing schedule: Week 16
|
0.00148 1/hour
Standard Deviation 0.000815
|
|
Terminal Elimination Rate Constant (Lambda z) of Antigen-Specific Haemophilus Influenza Type B Antibodies
21-day dosing schedule: Week 18
|
0.00192 1/hour
Standard Deviation 0.000276
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Average concentration of antigen-specific haemophilus influenza type B antibodies over the dosing interval (Cavg) was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=21 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Average Concentration of Antigen-Specific Haemophilus Influenza Type B Antibodies Over the Dosing Interval (Cavg)
28-day dosing schedule: Week 16
|
0.352 mg/dL
Standard Deviation 0.155
|
|
Average Concentration of Antigen-Specific Haemophilus Influenza Type B Antibodies Over the Dosing Interval (Cavg)
21-day dosing schedule: Week 18
|
0.474 mg/dL
Standard Deviation 0.0971
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
The peak trough fluctuation within complete dosing interval at steady state of antigen-specific haemophilus influenza type B antibodies was reported.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=21 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Percentage Peak Trough Fluctuation of Antigen-Specific Haemophilus Influenza Type B Antibodies
28-day dosing schedule: Week 16
|
141 percent fluctuation
Standard Deviation 72.8
|
|
Percentage Peak Trough Fluctuation of Antigen-Specific Haemophilus Influenza Type B Antibodies
21-day dosing schedule: Week 18
|
88.1 percent fluctuation
Standard Deviation 66.9
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: Pharmacokinetic (PK) Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule)/7th infusion (21-day infusion schedule). This set included all participants following principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Cmax was obtained directly from the concentration versus time curve. The Cmax for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8, serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 1
|
3.478 mg/L
Standard Deviation 2.7623
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 12
|
1.256 mg/L
Standard Deviation 1.2458
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 14
|
20.378 mg/L
Standard Deviation 46.3772
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 17
|
4.350 mg/L
Standard Deviation 5.6783
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 19
|
7.767 mg/L
Standard Deviation 8.5255
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 2
|
3.822 mg/L
Standard Deviation 1.2758
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 20
|
4.728 mg/L
Standard Deviation 3.0665
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 22
|
2.050 mg/L
Standard Deviation 1.3382
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 23
|
3.039 mg/L
Standard Deviation 3.3482
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 26
|
2.433 mg/L
Standard Deviation 1.3569
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 3
|
2.933 mg/L
Standard Deviation 1.6150
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 4
|
0.685 mg/L
Standard Deviation 0.2410
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 34
|
2.472 mg/L
Standard Deviation 0.9940
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 43
|
2.572 mg/L
Standard Deviation 1.1108
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 5
|
5.217 mg/L
Standard Deviation 4.0965
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 51
|
3.611 mg/L
Standard Deviation 1.3788
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 54
|
4.806 mg/L
Standard Deviation 2.0783
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 56
|
5.778 mg/L
Standard Deviation 11.7004
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 57
|
12.511 mg/L
Standard Deviation 21.4792
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 68
|
1.806 mg/L
Standard Deviation 0.8033
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 70
|
3.228 mg/L
Standard Deviation 1.6080
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 8
|
3.683 mg/L
Standard Deviation 2.6600
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 9
|
1.583 mg/L
Standard Deviation 0.7148
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 1
|
8.440 mg/L
Standard Deviation 8.3182
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 12
|
1.140 mg/L
Standard Deviation 0.1673
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 14
|
11.280 mg/L
Standard Deviation 3.5053
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 17
|
5.860 mg/L
Standard Deviation 4.0930
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 19
|
6.440 mg/L
Standard Deviation 1.0691
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 2
|
6.180 mg/L
Standard Deviation 4.6370
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 20
|
5.580 mg/L
Standard Deviation 1.8754
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 22
|
4.420 mg/L
Standard Deviation 5.4422
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 23
|
2.360 mg/L
Standard Deviation 0.8620
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 26
|
3.340 mg/L
Standard Deviation 2.5373
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 3
|
9.720 mg/L
Standard Deviation 12.7874
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 34
|
5.060 mg/L
Standard Deviation 6.2843
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 4
|
0.980 mg/L
Standard Deviation 0.6301
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 43
|
2.660 mg/L
Standard Deviation 0.7403
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 5
|
10.160 mg/L
Standard Deviation 12.4969
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 51
|
11.700 mg/L
Standard Deviation 14.2886
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 54
|
9.820 mg/L
Standard Deviation 10.6338
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 56
|
13.300 mg/L
Standard Deviation 19.3380
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 57
|
5.825 mg/L
Standard Deviation 0.9878
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 68
|
2.460 mg/L
Standard Deviation 1.7009
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 70
|
6.260 mg/L
Standard Deviation 7.0741
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 8
|
6.120 mg/L
Standard Deviation 4.5510
|
|
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 9
|
1.980 mg/L
Standard Deviation 0.7294
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The t1/2 for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=13 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 4
|
522.15 hours
Standard Deviation 39.466
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 5
|
632.03 hours
Standard Deviation 220.955
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 51
|
794.63 hours
Standard Deviation 474.015
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 23
|
837.29 hours
Standard Deviation 476.321
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 26
|
638.60 hours
Standard Deviation 285.966
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 3
|
626.69 hours
Standard Deviation 275.200
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 34
|
680.14 hours
Standard Deviation 400.291
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 43
|
573.32 hours
Standard Deviation 191.776
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 17
|
568.11 hours
Standard Deviation 184.079
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 19
|
794.76 hours
Standard Deviation 365.625
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 2
|
943.63 hours
Standard Deviation 597.812
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 20
|
977.87 hours
Standard Deviation 511.568
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 22
|
574.22 hours
Standard Deviation 258.366
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 54
|
1184.97 hours
Standard Deviation 1088.054
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 12
|
415.27 hours
Standard Deviation 104.179
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 1
|
533.06 hours
Standard Deviation 279.860
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 70
|
709.41 hours
Standard Deviation 282.061
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 8
|
562.30 hours
Standard Deviation 138.178
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 9
|
555.66 hours
Standard Deviation 274.555
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 1
|
813.74 hours
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 12
|
498.21 hours
Standard Deviation 105.271
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 14
|
1467.24 hours
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 17
|
1161.62 hours
Standard Deviation 409.606
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 19
|
839.73 hours
Standard Deviation 867.812
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 2
|
860.60 hours
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 20
|
779.88 hours
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 22
|
966.61 hours
Standard Deviation 104.462
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 23
|
805.76 hours
Standard Deviation 155.609
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 26
|
900.44 hours
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 3
|
292.95 hours
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 34
|
820.04 hours
Standard Deviation 92.314
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 4
|
638.35 hours
Standard Deviation 549.756
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 43
|
295.34 hours
Standard Deviation 120.334
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 5
|
825.99 hours
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 51
|
813.32 hours
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 54
|
754.20 hours
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 56
|
931.50 hours
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 68
|
259.63 hours
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 70
|
1437.71 hours
Standard Deviation 1083.055
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 8
|
616.54 hours
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 9
|
890.30 hours
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 14
|
737.33 hours
Standard Deviation 293.005
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 56
|
527.75 hours
Standard Deviation 144.729
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 57
|
1346.21 hours
Standard Deviation 1574.359
|
|
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 68
|
688.31 hours
Standard Deviation 354.982
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. AUC0-t of antigen-pneumococcal capsular polysaccharide was measured in hour\*microgram per milliliter (hr\*mcg/mL). The AUC0-t for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 57
|
1946.7526 hr*mg/L
Standard Deviation 134.44174
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 1
|
1267.2703 hr*mg/L
Standard Deviation 1231.86109
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 12
|
481.8080 hr*mg/L
Standard Deviation 615.13837
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 14
|
7680.6757 hr*mg/L
Standard Deviation 17443.37339
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 17
|
1707.2987 hr*mg/L
Standard Deviation 2326.27590
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 19
|
3264.5178 hr*mg/L
Standard Deviation 4922.67289
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 2
|
1462.1037 hr*mg/L
Standard Deviation 491.94211
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 20
|
1776.5915 hr*mg/L
Standard Deviation 1472.71297
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 22
|
767.3831 hr*mg/L
Standard Deviation 752.08067
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 23
|
1206.7604 hr*mg/L
Standard Deviation 1547.47617
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 26
|
929.6216 hr*mg/L
Standard Deviation 696.05624
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 3
|
940.1352 hr*mg/L
Standard Deviation 397.58653
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 34
|
916.8877 hr*mg/L
Standard Deviation 339.74807
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 4
|
245.8296 hr*mg/L
Standard Deviation 89.81281
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 43
|
901.9934 hr*mg/L
Standard Deviation 415.28147
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 5
|
1882.0174 hr*mg/L
Standard Deviation 1606.54653
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 51
|
1313.1756 hr*mg/L
Standard Deviation 285.57756
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 54
|
1659.0010 hr*mg/L
Standard Deviation 487.17054
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 56
|
2361.1009 hr*mg/L
Standard Deviation 5435.67901
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 57
|
5140.5242 hr*mg/L
Standard Deviation 10426.05050
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 68
|
637.6826 hr*mg/L
Standard Deviation 180.23219
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 70
|
1239.3842 hr*mg/L
Standard Deviation 746.05163
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 8
|
1396.1732 hr*mg/L
Standard Deviation 1343.80361
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 9
|
545.3315 hr*mg/L
Standard Deviation 201.37388
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 1
|
3361.3444 hr*mg/L
Standard Deviation 3529.24121
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 12
|
364.7574 hr*mg/L
Standard Deviation 66.07380
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 14
|
4026.2582 hr*mg/L
Standard Deviation 1827.76472
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 17
|
2327.4433 hr*mg/L
Standard Deviation 1869.77732
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 19
|
2139.8818 hr*mg/L
Standard Deviation 546.99394
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 2
|
2388.1819 hr*mg/L
Standard Deviation 2054.90148
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 20
|
2088.0431 hr*mg/L
Standard Deviation 956.15600
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 22
|
1728.1721 hr*mg/L
Standard Deviation 2363.07921
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 23
|
826.4154 hr*mg/L
Standard Deviation 390.75602
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 26
|
1199.7678 hr*mg/L
Standard Deviation 1115.65007
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 3
|
3834.6179 hr*mg/L
Standard Deviation 5425.47048
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 34
|
2095.6088 hr*mg/L
Standard Deviation 2982.98719
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 4
|
363.5605 hr*mg/L
Standard Deviation 289.99268
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 43
|
919.1971 hr*mg/L
Standard Deviation 290.08829
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 5
|
4050.8597 hr*mg/L
Standard Deviation 5582.10279
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 51
|
4775.1477 hr*mg/L
Standard Deviation 6034.17097
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 54
|
3849.0042 hr*mg/L
Standard Deviation 4696.54103
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 56
|
5069.9328 hr*mg/L
Standard Deviation 7483.01937
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 68
|
900.2735 hr*mg/L
Standard Deviation 757.57732
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 70
|
2385.0419 hr*mg/L
Standard Deviation 3013.20369
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 8
|
2555.3317 hr*mg/L
Standard Deviation 2162.87976
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 9
|
707.9849 hr*mg/L
Standard Deviation 310.25117
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The AUC0-inf for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20 serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=3 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 1
|
835.7493 hr*mg/L
|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 17
|
815.5984 hr*mg/L
|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 22
|
706.0824 hr*mg/L
Standard Deviation 101.30543
|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 3
|
753.3039 hr*mg/L
|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 56
|
871.0663 hr*mg/L
|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 9
|
494.5129 hr*mg/L
|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 43
|
1072.8342 hr*mg/L
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule. The AUCtau for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=21 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 1
|
1295.2208 hr*mg/L
Standard Deviation 1284.98717
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 12
|
496.5246 hr*mg/L
Standard Deviation 652.01919
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 14
|
7938.1617 hr*mg/L
Standard Deviation 18005.53693
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 17
|
1128.6509 hr*mg/L
Standard Deviation 606.69308
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 19
|
2051.7286 hr*mg/L
Standard Deviation 805.43957
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 2
|
1437.7169 hr*mg/L
Standard Deviation 551.52102
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 20
|
1738.1297 hr*mg/L
Standard Deviation 1558.89268
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 22
|
759.1847 hr*mg/L
Standard Deviation 785.00558
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 23
|
1221.7947 hr*mg/L
Standard Deviation 1608.36169
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 26
|
929.6706 hr*mg/L
Standard Deviation 739.10055
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 3
|
902.9745 hr*mg/L
Standard Deviation 415.50944
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 34
|
879.5261 hr*mg/L
Standard Deviation 347.31703
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 4
|
241.3102 hr*mg/L
Standard Deviation 93.08585
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 43
|
934.7032 hr*mg/L
Standard Deviation 507.01946
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 5
|
1525.6893 hr*mg/L
Standard Deviation 617.53144
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 51
|
1327.8807 hr*mg/L
Standard Deviation 304.68999
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 54
|
1665.6043 hr*mg/L
Standard Deviation 473.20463
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 56
|
2456.3187 hr*mg/L
Standard Deviation 5608.60157
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 57
|
5157.6297 hr*mg/L
Standard Deviation 10068.88936
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 68
|
646.0577 hr*mg/L
Standard Deviation 303.83828
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 70
|
1242.0569 hr*mg/L
Standard Deviation 791.72945
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 8
|
1112.3875 hr*mg/L
Standard Deviation 364.77366
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 9
|
549.2854 hr*mg/L
Standard Deviation 205.21945
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 1
|
3427.1894 hr*mg/L
Standard Deviation 4395.22135
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 12
|
340.6625 hr*mg/L
Standard Deviation 40.16239
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 14
|
4203.7328 hr*mg/L
Standard Deviation 2074.59529
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 17
|
2120.4069 hr*mg/L
Standard Deviation 1774.61729
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 19
|
2588.0431 hr*mg/L
Standard Deviation 884.21458
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 2
|
1995.4796 hr*mg/L
Standard Deviation 1312.64625
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 20
|
2571.9984 hr*mg/L
Standard Deviation 1782.65587
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 22
|
860.7046 hr*mg/L
Standard Deviation 377.70459
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 23
|
1074.8702 hr*mg/L
Standard Deviation 591.84867
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 26
|
1640.1471 hr*mg/L
Standard Deviation 1585.98684
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 3
|
6340.4080 hr*mg/L
Standard Deviation 9208.98601
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 34
|
871.0315 hr*mg/L
Standard Deviation 46.94825
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 4
|
464.1417 hr*mg/L
Standard Deviation 438.74819
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 43
|
971.2482 hr*mg/L
Standard Deviation 311.33350
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 5
|
1536.7299 hr*mg/L
Standard Deviation 239.98044
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 51
|
5984.7197 hr*mg/L
Standard Deviation 8063.82766
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 54
|
4422.4410 hr*mg/L
Standard Deviation 5245.59189
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 56
|
6780.9969 hr*mg/L
Standard Deviation 9967.85603
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 57
|
2280.6541 hr*mg/L
Standard Deviation 245.58661
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 68
|
1209.1992 hr*mg/L
Standard Deviation 1169.34365
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 70
|
1136.7545 hr*mg/L
Standard Deviation 243.27839
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 8
|
2145.6232 hr*mg/L
Standard Deviation 1950.12455
|
|
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 9
|
764.0375 hr*mg/L
Standard Deviation 331.36438
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Vd was defined as the the theoretical volume in which the total amount of anti-pneumococcal capsular polysaccharide would need to be uniformly distributed to produce the desired blood concentration of a anti-pneumococcal capsular polysaccharide. The Vd for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=3 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Volume of Distribution (Vd) of of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 1
|
329057.3200 mL/kg
|
|
Volume of Distribution (Vd) of of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 17
|
341197.1700 mL/kg
|
|
Volume of Distribution (Vd) of of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 22
|
231539.8050 mL/kg
Standard Deviation 104298.38458
|
|
Volume of Distribution (Vd) of of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 3
|
226738.9500 mL/kg
|
|
Volume of Distribution (Vd) of of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 56
|
342896.0600 mL/kg
|
|
Volume of Distribution (Vd) of of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 9
|
526016.9000 mL/kg
|
|
Volume of Distribution (Vd) of of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 43
|
283171.4700 mL/kg
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Clearance of a anti-pneumococcal capsular polysaccharide antibodies was a measure of the rate at which a anti-pneumococcal capsular polysaccharide antibodies are metabolized or eliminated by normal biological processes. The CLss of anti-pneumococcal capsular polysaccharide antibodies was reported. The CLss of anti-pneumococcal capsular polysaccharide antibodies was measured in milligrams\*milliliter per hour\*international unit\*kilogram (mg\*mL/hr\*IU\*kg). The CLss for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=3 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Steady State Clearance (CLss) of Anti-pneumococcal Capsular Polysaccharide Antibodies (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 1
|
860.4600 mg*mL/hr*IU*kg
|
|
Steady State Clearance (CLss) of Anti-pneumococcal Capsular Polysaccharide Antibodies (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 17
|
862.3000 mg*mL/hr*IU*kg
|
|
Steady State Clearance (CLss) of Anti-pneumococcal Capsular Polysaccharide Antibodies (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 22
|
604.0850 mg*mL/hr*IU*kg
Standard Deviation 190.31779
|
|
Steady State Clearance (CLss) of Anti-pneumococcal Capsular Polysaccharide Antibodies (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 3
|
705.5700 mg*mL/hr*IU*kg
|
|
Steady State Clearance (CLss) of Anti-pneumococcal Capsular Polysaccharide Antibodies (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 56
|
854.8300 mg*mL/hr*IU*kg
|
|
Steady State Clearance (CLss) of Anti-pneumococcal Capsular Polysaccharide Antibodies (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 9
|
1441.7300 mg*mL/hr*IU*kg
|
|
Steady State Clearance (CLss) of Anti-pneumococcal Capsular Polysaccharide Antibodies (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 43
|
849.0400 mg*mL/hr*IU*kg
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "number analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve. The Cmin for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 1
|
1.167 mg/L
Standard Deviation 0.7577
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 12
|
0.528 mg/L
Standard Deviation 0.8259
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 14
|
8.361 mg/L
Standard Deviation 19.9012
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 17
|
2.328 mg/L
Standard Deviation 4.4311
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 19
|
3.783 mg/L
Standard Deviation 6.2568
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 2
|
1.656 mg/L
Standard Deviation 0.8487
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 20
|
1.689 mg/L
Standard Deviation 0.7522
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 22
|
0.817 mg/L
Standard Deviation 1.0257
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 23
|
1.228 mg/L
Standard Deviation 1.8588
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 26
|
0.978 mg/L
Standard Deviation 0.6804
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 3
|
0.950 mg/L
Standard Deviation 0.5924
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 34
|
1.033 mg/L
Standard Deviation 0.6903
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 4
|
0.277 mg/L
Standard Deviation 0.1235
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 43
|
0.983 mg/L
Standard Deviation 0.6600
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 5
|
2.306 mg/L
Standard Deviation 3.2598
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 51
|
1.406 mg/L
Standard Deviation 0.4771
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 54
|
1.733 mg/L
Standard Deviation 0.6598
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 56
|
2.750 mg/L
Standard Deviation 6.7280
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 57
|
5.422 mg/L
Standard Deviation 10.7795
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 68
|
0.728 mg/L
Standard Deviation 0.4390
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 70
|
1.350 mg/L
Standard Deviation 0.9931
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 8
|
1.294 mg/L
Standard Deviation 0.6476
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 9
|
0.517 mg/L
Standard Deviation 0.2550
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18 : Serotype 1
|
5.400 mg/L
Standard Deviation 6.4211
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18 : Serotype 12
|
0.440 mg/L
Standard Deviation 0.1817
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18 : Serotype 14
|
5.880 mg/L
Standard Deviation 4.0084
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18 : Serotype 17
|
3.700 mg/L
Standard Deviation 3.3978
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18 : Serotype 19
|
2.940 mg/L
Standard Deviation 1.3107
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18 : Serotype 2
|
3.600 mg/L
Standard Deviation 3.6159
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18 : Serotype 20
|
3.120 mg/L
Standard Deviation 1.8992
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18 : Serotype 22
|
2.520 mg/L
Standard Deviation 3.6486
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18 : Serotype 23
|
1.200 mg/L
Standard Deviation 0.8660
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 26
|
1.740 mg/L
Standard Deviation 1.9191
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 3
|
5.920 mg/L
Standard Deviation 8.6126
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 34
|
3.220 mg/L
Standard Deviation 5.0226
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 4
|
0.520 mg/L
Standard Deviation 0.5630
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 43
|
1.300 mg/L
Standard Deviation 0.8031
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 5
|
6.240 mg/L
Standard Deviation 9.6619
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 51
|
7.620 mg/L
Standard Deviation 10.4406
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 54
|
5.980 mg/L
Standard Deviation 8.1515
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 56
|
7.820 mg/L
Standard Deviation 12.0038
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 57
|
2.375 mg/L
Standard Deviation 0.5909
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 68
|
1.400 mg/L
Standard Deviation 1.5700
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 70
|
3.920 mg/L
Standard Deviation 5.6971
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 8
|
4.260 mg/L
Standard Deviation 4.2846
|
|
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 9
|
1.040 mg/L
Standard Deviation 0.6804
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Tmax was obtained directly from the concentration versus time curve. The Tmax for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=23 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 54
|
0.642 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 9
|
0.500 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18 Serotype 14
|
70.450 hours
Interval 0.5 to 334.37
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18 Serotype 1
|
71.250 hours
Interval 1.78 to 334.37
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18 Serotype 12
|
1.783 hours
Interval 0.5 to 334.37
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 56
|
1.633 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 57
|
0.642 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 68
|
0.650 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 70
|
0.500 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 8
|
0.542 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 1
|
0.542 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 12
|
0.517 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 14
|
1.417 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 17
|
1.992 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 19
|
0.642 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 2
|
1.458 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 22
|
0.500 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 23
|
0.642 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 26
|
0.642 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 3
|
0.517 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 34
|
1.758 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 4
|
0.500 hours
Interval 0.48 to 24.1
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 43
|
1.750 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 5
|
0.642 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 51
|
0.650 hours
Interval 0.48 to 529.75
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 17
|
71.250 hours
Interval 1.78 to 337.3
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 19
|
1.967 hours
Interval 0.53 to 334.37
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 2
|
71.250 hours
Interval 1.78 to 337.3
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 20
|
2.050 hours
Interval 1.78 to 457.0
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 22
|
71.250 hours
Interval 1.78 to 337.3
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 23
|
2.050 hours
Interval 0.5 to 334.37
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 26
|
71.250 hours
Interval 1.78 to 334.37
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 3
|
71.250 hours
Interval 2.05 to 457.0
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 34
|
1.967 hours
Interval 0.53 to 334.37
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 4
|
1.783 hours
Interval 0.5 to 334.37
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 43
|
1.967 hours
Interval 0.53 to 457.0
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 5
|
71.250 hours
Interval 1.78 to 337.3
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 51
|
71.250 hours
Interval 0.53 to 334.37
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 54
|
71.250 hours
Interval 1.78 to 334.37
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 56
|
71.250 hours
Interval 1.78 to 334.37
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 57
|
70.850 hours
Interval 0.53 to 334.37
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 68
|
24.700 hours
Interval 0.5 to 334.37
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 70
|
1.967 hours
Interval 0.48 to 71.25
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 8
|
2.050 hours
Interval 1.78 to 334.37
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 9
|
70.450 hours
Interval 0.53 to 334.37
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The Kel for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20 serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=12 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 1
|
0.0016 1/hour
Standard Deviation 0.00081
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 12
|
0.0017 1/hour
Standard Deviation 0.00037
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 14
|
0.0011 1/hour
Standard Deviation 0.00037
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 17
|
0.0014 1/hour
Standard Deviation 0.00069
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 19
|
0.0010 1/hour
Standard Deviation 0.00039
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 2
|
0.0010 1/hour
Standard Deviation 0.00054
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 20
|
0.0009 1/hour
Standard Deviation 0.00063
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 22
|
0.0015 1/hour
Standard Deviation 0.00082
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 23
|
0.0010 1/hour
Standard Deviation 0.00038
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 26
|
0.0013 1/hour
Standard Deviation 0.00057
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 3
|
0.0014 1/hour
Standard Deviation 0.00078
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 34
|
0.0013 1/hour
Standard Deviation 0.00068
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 4
|
0.0013 1/hour
Standard Deviation 0.00011
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 43
|
0.0013 1/hour
Standard Deviation 0.00041
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 5
|
0.0012 1/hour
Standard Deviation 0.00036
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 51
|
0.0012 1/hour
Standard Deviation 0.00072
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 54
|
0.0009 1/hour
Standard Deviation 0.00052
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 56
|
0.0014 1/hour
Standard Deviation 0.00053
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 57
|
0.0010 1/hour
Standard Deviation 0.00059
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 68
|
0.0012 1/hour
Standard Deviation 0.00051
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 70
|
0.0011 1/hour
Standard Deviation 0.00047
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 8
|
0.0013 1/hour
Standard Deviation 0.00043
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 9
|
0.0015 1/hour
Standard Deviation 0.00083
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 1
|
0.0009 1/hour
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 12
|
0.0014 1/hour
Standard Deviation 0.00030
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 14
|
0.0005 1/hour
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 17
|
0.0006 1/hour
Standard Deviation 0.00022
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 19
|
0.0018 1/hour
Standard Deviation 0.00183
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 2
|
0.0008 1/hour
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 20
|
0.0009 1/hour
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 22
|
0.0007 1/hour
Standard Deviation 0.00008
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 23
|
0.0009 1/hour
Standard Deviation 0.00017
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 26
|
0.0008 1/hour
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 3
|
0.0024 1/hour
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 34
|
0.0009 1/hour
Standard Deviation 0.00010
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 4
|
0.0016 1/hour
Standard Deviation 0.00094
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 43
|
0.0026 1/hour
Standard Deviation 0.00104
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 5
|
0.0008 1/hour
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 51
|
0.0009 1/hour
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 54
|
0.0009 1/hour
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 56
|
0.0007 1/hour
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 68
|
0.0027 1/hour
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 70
|
0.0007 1/hour
Standard Deviation 0.00051
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 8
|
0.0011 1/hour
|
|
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 9
|
0.0008 1/hour
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
Average concentration of anti-pneumococcal capsular polysaccharide over the dosing interval (Cavg) was reported. The Cavg for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=21 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 1
|
1.9274 mg/L
Standard Deviation 1.91218
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 12
|
0.7389 mg/L
Standard Deviation 0.97027
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 14
|
11.8127 mg/L
Standard Deviation 26.793
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 17
|
1.7723 mg/L
Standard Deviation 0.86237
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 19
|
3.2992 mg/L
Standard Deviation 1.55795
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 2
|
2.2719 mg/L
Standard Deviation 0.84758
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 20
|
2.6925 mg/L
Standard Deviation 2.27169
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 22
|
1.1703 mg/L
Standard Deviation 1.14923
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 23
|
1.8608 mg/L
Standard Deviation 2.37096
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 26
|
1.4473 mg/L
Standard Deviation 1.09160
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 3
|
1.4018 mg/L
Standard Deviation 0.57076
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 34
|
1.4310 mg/L
Standard Deviation 0.67369
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 4
|
0.3715 mg/L
Standard Deviation 0.13038
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 43
|
1.3909 mg/L
Standard Deviation 0.75449
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 5
|
2.2704 mg/L
Standard Deviation 0.91895
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 51
|
1.9760 mg/L
Standard Deviation 0.45341
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 54
|
2.4786 mg/L
Standard Deviation 0.70417
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 56
|
3.6552 mg/L
Standard Deviation 8.34613
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 57
|
7.7851 mg/L
Standard Deviation 14.9518
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 68
|
1.0037 mg/L
Standard Deviation 0.43741
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 70
|
1.8656 mg/L
Standard Deviation 1.16519
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 8
|
1.6553 mg/L
Standard Deviation 0.54282
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 9
|
0.8174 mg/L
Standard Deviation 0.30539
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 1
|
6.8000 mg/L
Standard Deviation 8.72068
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 12
|
0.6759 mg/L
Standard Deviation 0.07969
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 14
|
8.3407 mg/L
Standard Deviation 4.11626
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 17
|
3.3332 mg/L
Standard Deviation 2.49783
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 19
|
4.1177 mg/L
Standard Deviation 1.24514
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 2
|
3.1566 mg/L
Standard Deviation 1.78858
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 20
|
4.0521 mg/L
Standard Deviation 2.44372
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 22
|
1.3653 mg/L
Standard Deviation 0.45325
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 23
|
1.6720 mg/L
Standard Deviation 0.80975
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 26
|
2.5183 mg/L
Standard Deviation 2.29821
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 3
|
9.6039 mg/L
Standard Deviation 13.55999
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 34
|
1.4352 mg/L
Standard Deviation 0.21030
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 4
|
0.7559 mg/L
Standard Deviation 0.61634
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 43
|
1.9271 mg/L
Standard Deviation 0.61773
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 5
|
3.0491 mg/L
Standard Deviation 0.47615
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 51
|
11.8744 mg/L
Standard Deviation 15.99966
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 54
|
8.7747 mg/L
Standard Deviation 10.40792
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 56
|
13.4544 mg/L
Standard Deviation 19.77749
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 57
|
3.7348 mg/L
Standard Deviation 0.38721
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 68
|
1.8682 mg/L
Standard Deviation 1.69358
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 70
|
2.0323 mg/L
Standard Deviation 0.31507
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 8
|
4.2572 mg/L
Standard Deviation 3.86929
|
|
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 9
|
1.5159 mg/L
Standard Deviation 0.65747
|
SECONDARY outcome
Timeframe: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusionPopulation: PK evaluation set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points as per dosing schedule.
The peak trough fluctuation within complete dosing interval at steady state of anti-pneumococcal capsular polysaccharide was reported. The peak trough fluctuation for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Outcome measures
| Measure |
Kedrion IVIG 10%
n=22 Participants
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 26
|
122.7546 percent fluctuation
Standard Deviation 65.89653
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 23
|
116.7754 percent fluctuation
Standard Deviation 45.77432
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 3
|
139.1737 percent fluctuation
Standard Deviation 50.45738
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 34
|
112.0465 percent fluctuation
Standard Deviation 48.26345
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 4
|
117.2909 percent fluctuation
Standard Deviation 65.62829
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 43
|
125.0358 percent fluctuation
Standard Deviation 49.91946
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 5
|
124.7428 percent fluctuation
Standard Deviation 49.15063
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 1
|
128.3177 percent fluctuation
Standard Deviation 62.60668
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 51
|
110.9231 percent fluctuation
Standard Deviation 48.65621
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 54
|
123.3022 percent fluctuation
Standard Deviation 53.42626
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 56
|
116.6480 percent fluctuation
Standard Deviation 52.81535
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 57
|
111.5242 percent fluctuation
Standard Deviation 42.65179
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 68
|
114.0701 percent fluctuation
Standard Deviation 58.01418
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 70
|
109.4081 percent fluctuation
Standard Deviation 43.80010
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 8
|
117.3221 percent fluctuation
Standard Deviation 38.97972
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 9
|
130.6095 percent fluctuation
Standard Deviation 65.79680
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 1
|
81.4603 percent fluctuation
Standard Deviation 40.27141
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 12
|
102.9813 percent fluctuation
Standard Deviation 10.00904
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 14
|
73.9639 percent fluctuation
Standard Deviation 29.28795
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 17
|
76.0492 percent fluctuation
Standard Deviation 42.17688
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 19
|
94.4390 percent fluctuation
Standard Deviation 30.99072
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 2
|
80.1377 percent fluctuation
Standard Deviation 36.22955
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 20
|
83.5202 percent fluctuation
Standard Deviation 42.23144
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 22
|
91.9216 percent fluctuation
Standard Deviation 20.16314
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 23
|
84.5653 percent fluctuation
Standard Deviation 31.15550
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 26
|
88.7836 percent fluctuation
Standard Deviation 30.46916
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 3
|
90.4017 percent fluctuation
Standard Deviation 39.81294
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 34
|
91.6269 percent fluctuation
Standard Deviation 16.96157
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 4
|
79.5022 percent fluctuation
Standard Deviation 41.16158
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 43
|
81.6962 percent fluctuation
Standard Deviation 28.91186
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 5
|
88.6356 percent fluctuation
Standard Deviation 17.56577
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 51
|
71.0749 percent fluctuation
Standard Deviation 31.74626
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 54
|
72.7200 percent fluctuation
Standard Deviation 31.26330
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 56
|
82.4508 percent fluctuation
Standard Deviation 27.11113
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 57
|
98.1611 percent fluctuation
Standard Deviation 9.69314
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 68
|
82.9015 percent fluctuation
Standard Deviation 37.95746
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 70
|
91.3286 percent fluctuation
Standard Deviation 19.12896
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 8
|
65.5637 percent fluctuation
Standard Deviation 36.02827
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
21-day dosing schedule: Week 18: Serotype 9
|
75.8333 percent fluctuation
Standard Deviation 30.77330
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 12
|
125.2166 percent fluctuation
Standard Deviation 64.54247
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 14
|
107.5731 percent fluctuation
Standard Deviation 40.60933
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 17
|
103.6118 percent fluctuation
Standard Deviation 35.89546
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 19
|
110.9054 percent fluctuation
Standard Deviation 50.44522
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 2
|
105.2306 percent fluctuation
Standard Deviation 55.00248
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 20
|
114.6004 percent fluctuation
Standard Deviation 41.03380
|
|
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
28-day dosing schedule: Week 16: Serotype 22
|
128.1639 percent fluctuation
Standard Deviation 58.30342
|
Adverse Events
Kedrion IVIG 10%
Serious adverse events
| Measure |
Kedrion IVIG 10%
n=47 participants at risk
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.1%
1/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.1%
1/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.1%
1/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
2.1%
1/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
2.1%
1/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Kedrion IVIG 10%
n=47 participants at risk
Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
|
|---|---|
|
Nervous system disorders
Headache
|
40.4%
19/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
25.5%
12/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
23.4%
11/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Nervous system disorders
Sinusitis
|
23.4%
11/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
upper respiratory tract infection
|
17.0%
8/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
17.0%
8/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.9%
7/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
12.8%
6/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Investigations
Coombs direct test positive
|
12.8%
6/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
12.8%
6/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
8.5%
4/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.5%
4/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Influenzae
|
6.4%
3/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
6.4%
3/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.4%
3/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Toothache
|
6.4%
3/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.4%
3/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
General disorders
Chills
|
6.4%
3/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
General disorders
Pain
|
6.4%
3/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.4%
3/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
6.4%
3/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.4%
3/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.4%
3/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
3/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
6.4%
3/47 • Up to study termination visit (Week 52)
The SAF included all participants who had received at least 1 dose of study medication.
|
Additional Information
Dr. Mirella Calcinai, MD, Clinical Research Director
Kedrion S.p.A
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the Investigators can be divulged to third parties from the trial team only after Kedrion's approval.
- Publication restrictions are in place
Restriction type: OTHER