Primary Immunodeficiency Disease
Conditions
Keywords
Immunoglobulin, Kedrion IVIg10%, IgG antibodies, Agammaglobulinemia, Hypogammaglobulinemia
Brief summary
The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).
Interventions
BIOLOGICALKedrion IVIG 10%
Kedrion intravenous immunoglobulin (IVIg) 10%
Sponsors
Kedrion S.p.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent/assent obtained from participant/participant's parent(s) or legally acceptable representative indicating that they understand the purpose of and procedures required for the study and are willing to participate in it. * Confirmed clinical diagnosis of a PID, requiring treatment with IVIg and have documented agammaglobulinemia (defined as the total absence of one or more classes of antibodies) or hypogammaglobulinemia (defined as low levels of one or more classes \[that is at least 2 standard deviations under the mean level per age\]) * Male or female, ages 2 to 70 years at screening * Received 200 to 800 mg/kg of a commercially available IVIg therapy in the range of 21- or 28-day intervals (±3 days or ±4 days, respectively) for at least 3 infusion cycles prior to screening * At least 2 documented IgG trough levels while receiving an IVIg, of greater than or equals to (\>=) 6 gram per liter (g/L) obtained at 2 infusion cycles within 12 months (1 must be within 6 months) prior to Informed Consent Form (ICF) signature * Participant is willing to comply all requirements of the protocol. * Females of child-bearing potential with a negative urine pregnancy test and who agree to employ adequate birth control measures during the study * Authorization to access personal health information * Participant previously participating in a clinical trial with another experimental IVIg may be enrolled if they have received stable commercially available IVIg therapy for at least 3 infusion cycles (21 or 28 days) prior to screening * Participant currently on treatment with any subcutaneous immunoglobulin (SCIG) can be enrolled if they are switched to stable commercially available IVIg therapy for at least 3 infusion cycles (21 or 28 days) prior to screening
Exclusion criteria
* Newly diagnosed PID and and naïve to IgG replacement therapy * Dysgammaglobulinemia (defined as a deficiency in one or more classes of antibodies, but not severe enough to require substitutive therapy) or isolated IgG subclass deficiency or profound primary T-cell deficiency (defined as the absence or severe reduction of T lymphocytes \[CD3+ \<300 cells per cubic millimeter (cell/mm3)\] and an absent or particularly low proliferative response \[10% of the lower normal range\] to phytohaemagglutinin P \[PHA\]) * Has history of severe or serious reactions or hypersensitivity to IVIg or other injectable forms of IgG * Has history of thrombotic events (including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction), as defined by at least 1 event in participant's lifetime * Has IgA deficiency with documented antibodies to IgA * Have received blood products that have not undergone viral inactivation measures within 12 months prior to Informed Consent Form (ICF) signature * Has significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia * Has an acute infection as documented by culture or diagnostic imaging and/or a body temperature \>= 38 degree Celsius (°C) (\>=100.4 degree Fahrenheit (°F) within 7 days prior to screening * Has acquired immunodeficiency syndrome (AIDS) and/or hepatitis B/C active disease at ICF signature * Has levels of Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), 2.5 times of the upper limit of normal for the laboratory designated for the study * Using an implanted venous access device * Has profound anemia (haemoglobin less than10 gram per deciliter \[g/dl\]) or persistent severe neutropenia (\<= 1000 neutrophils per millimeter cube (mm\^3) or lymphopenia of less than 500 cells per microliter * Have severe chronic condition such as renal failure (creatinine concentration \> 2.0 times the upper limit of normal) with proteinuria, congestive heart failure (New York Heart Association III/IV), cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g., atrial fibrillation), unstable or advanced ischemic heart disease, hyper viscosity, or any other condition that the Investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial. Normal values for serum creatinine are the following: a) Female (18+ years): 45 - 84 micromole per liter (mcmol/L) or 0.51 - 0.95 milligrams per deciliter (mg/dl); b) Male (18+ years): 59 - 103 mcmol/L or 0.67 - 1.17 mg/dl * Has history of a malignant disease other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin within 24 months prior to ICF signature * Has history of pharmacoresistant epilepsy or multiple episodes of migraine (defined as at least 1 episode within 6 months of ICF signature) not completely controlled by medication * Participants must not be receiving steroids (oral or parenteral daily dose of \>= 0.15 milligram per kilogram per day (mg/kg/day) of prednisone or equivalent) or other immunosuppressive drugs or chemotherapy * Females who are pregnant, breast feeding or planning a pregnancy during the course of the study. Women who become pregnant during the study will be withdrawn from the study * Has participated in another clinical study within 3 weeks prior to study ICF signature * Has history of drug or alcohol abuse within the 6 months before screening * Has Employed or a direct relative of an employee of the CRO, the study site, or the Sponsor * Previously treated under this protocol * Unable to provide informed consent or provide informed consent by a legally authorized representative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Acute Serious Bacterial Infections (ABSIs) | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Incidence rate was defined as the mean number of acute serious bacterial infections (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) per participant-year according to pre-specified criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Immunoglobulin G (IgG) Trough Levels | At baseline, Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | The serum IgG trough levels were collected and analyzed at a central laboratory. |
| Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | At baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule) | IgG subclasses levels (IgG1, IgG2, IgG3, IgG4) were collected and analyzed at a central laboratory. |
| Number of Participants With Total Immunoglobulin G (IgG) Trough Levels Less Than or Equal to (<=) 6 Grams/Liter (g/L) Criteria | Up to 12 months | Number of participants with Total IgG trough levels \<= 6 g/L criteria were reported. |
| Anti-Tetanus Toxoid Antibody Levels | Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule) | The anti-tetanus toxoid antibody levels were collected and analyzed at a central laboratory. This antibody level was measured in international units per milliliter (IU/mL). |
| Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule) | Anti-pneumococcal capsular polysaccharide antibody levels for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 were collected and analyzed at a central laboratory. |
| Anti-Measles Antibody Levels | Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule) | The anti-measles antibody levels were collected and analyzed at a central laboratory. |
| Anti-Haemophilus Influenza Type B Antibody Levels | Baseline, Weeks 16, 32 and 48 (28 -day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule) | The anti-haemophilus influenza type B antibody levels were collected and analyzed at central laboratory. |
| Incidence Rate of Any Infection Other Than Acute Serious Bacterial Infections | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Incidence rate was defined as the mean number of any infection other than acute serious bacterial infections (bacterial pneumonia, bacteraemia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) per participant-year. Incidence rate of any infection other than acute bacterial serious infections collected by the participant/participants parent(s)/legal guardian(s) in the participant diary or during clinic visit was reported. |
| Duration of Any Infection Other Than Acute Serious Bacterial Infections | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Duration of any infection other than serious acute bacterial infections (in days) was calculated as date of stop of infection - date of start of infection + 1. Duration of any infection other than serious acute bacterial infections collected by the by the participant/participants parent(s)/legal guardian(s) in the participant diary or during clinic visit was reported. |
| Incidence Rate of Fever Episodes | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Incidence rate was defined as the mean number of fever episodes per participant-year. Incidence rate of fever episodes collected by the participant/participant's parent(s)/legal guardian(s) in the participant diary or during clinic visit were reported. |
| Duration of Fever Episodes in Participants | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Duration of fever episodes in participants was reported. |
| Duration of Overall Participants Hospitalization | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Duration of overall participants hospitalization was reported. |
| Duration of Participants Hospitalization Due to Infection | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Duration of participants hospitalization due to infection was reported. |
| Incidence Rate of Antibiotics Episodes for Treatment of Any Kind of Infections | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Incidence rate was defined as the mean number of antibiotics episodes per participant year. Incidence rate of participants on antibiotics for treatment of any kind of infections was reported. |
| Duration of Participants on Antibiotics for Treatment of Any Kind of Infection | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Duration of participants on antibiotics for treatment of any kind of infection was reported. |
| Duration of Missed School/Work/Other Major Activities Due to Infections | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Duration of missed school/work/other major activities due to infections was reported. |
| Pediatric Quality of Life Inventory (PedsQL) Score | Baseline, Week 24 (21-day dosing schedule and 28-day dosing schedule), Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | 23-item PedsQL generic core scales was a modular approach to measure health-related Quality of Life (QoL) in healthy children, adolescents and those with acute and chronic health conditions. The total scale score (23 items) consisted of Physical Health Summary Score (8 items) and Psychosocial Health SummaryScore (15 items). Physical health summary included Physical Functioning (8 items) and Psychosocial health summary score included Emotional Functioning (5 items), Social Functioning (5 items) and School Functioning (5 items). Items were scored on a 5 point Likert-type response scale: 0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; and 4=almost always a problem). Once scored, items were reverse scored and linearly transformed to a 0-100 scale, where higher scores indicated better QoL. The overall range for total PedsQL score (23 items) was 0 to 100, with higher score indicated better QoL. Data for 18-25 years and \>25 years age group was reported. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAE was defined as an AE with an onset that occurs after receiving study drug. Any TEAE included participants with both serious and non-serious TEAEs. |
| Number of TEAEs and Serious TEAEs | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. A SAE was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. A TEAE was defined as an AE with an onset that occurs after receiving study drug. Number of TEAEs and Serious TEAEs were reported. |
| Number of Drug Related Infusion Adverse Events (AEs) | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Number of drug related infusion AEs were reported. |
| Percentage of Participants Who Experienced at Least One Drug Related Infusion Adverse Events (AEs) | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Percentage of participants who experienced at least one drug related infusion AEs were reported. |
| Number of Infusions With Decreased Infusion Rate Due to Adverse Events (AEs) | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Number of infusions with decreased infusion rate due to AEs were reported. |
| Number of Infusions With One or More Infusion Associated Adverse Events (AEs) | Baseline up to Week 52 | The number of infusions with one or more infusion associated AEs were reported collectively for 21 and 28-day dosing schedule up to Week 52. |
| Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Vital signs included body temperature, systolic and diastolic blood pressure, heart rate and weight. The systolic and diastolic blood pressure and pulse rate was measured after the participants have in a rested at least 3 minutes in seated position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in vital signs were reported. |
| Number of Participants With Clinically Significant Changes From Baseline in Physical Examinations | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Physical examination included the examination of general appearance, skin, neck, eyes, ears, nose, throat, cardiovascular assessment including rhythm, and presence of other cardiac abnormalities (for example gallops, murmurs, cardiomegaly), respiratory system, gastrointestinal system, genitourinary system and musculoskeletal system. Clinical significance was decided by the investigator. The number of participants with clinically significant changes from baseline in physical examination were reported. |
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters | Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule) | Laboratory parameters included chemistry, hematology and urinalysis. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in laboratory parameters were reported. |
| Number of Participants With Positive Coomb's Test at Week 16 (28-day Dosing Schedule) and Week 18 (21-day Dosing Schedule) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule) | Intravascular hemolysis testing was performed by using coomb's test. The coomb's assessment was performed at a central laboratory. |
| Number of Participants With Positive Urine Hemosiderin Test | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule) | Number of participants with positive urine hemosiderin test were reported. |
| Number of Participants With Abnormal Plasma-free Haemoglobin Level | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule) | Number of participants with plasma-free haemoglobin level more than or equal to (\>=) 69 milligrams per deciliter (mg/dL) were consisdered as abormal and were reported. |
| Number of Participants With Abnormal Serum Haptoglobin Level | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule) | Number of participants with abnormal serum haptoglobin level were reported. |
| Maximum Observed Serum Concentration (Cmax) of Total Immunoglobulin G (IgG) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Cmax was obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported. |
| Elimination Half-Life (t1/2) of Total IgG | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported. |
| Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Total IgG | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. Both baseline corrected and un-corrected data was reported. |
| Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total IgG | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported. |
| Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Total IgG | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule. Both baseline corrected and un-corrected data was reported. |
| Volume of Distribution (Vd) of Total IgG | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Vd was defined as the the theoretical volume in which the total amount of total IgG would need to be uniformly distributed to produce the desired blood concentration of a total IgG. Both baseline corrected and un-corrected data was reported. |
| Steady State Clearance (CLss) of Total IgG | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Clearance of a total IgG was a measure of the rate at which a total IgG is metabolized or eliminated by normal biological processes. CLss of total IgG was measured in milliliters per hour per kilogram (mL/hr/kg). Both baseline corrected and un-corrected data was reported. |
| Minimum Observed Serum Concentration (Cmin) of Total IgG | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported. |
| Time to Reach the Maximum Serum Concentration (Tmax) of Total IgG | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Tmax was obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported. |
| Elimination Rate Constant (Kel) of Total IgG | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported. |
| Average Concentration of Total IgG Over the Dosing Interval (Cavg) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Average concentration of total IgG over the dosing interval (Cavg) was reported. Both baseline corrected and un-corrected data was reported. |
| Percentage Peak Trough Fluctuation of Total IgG | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | The peak trough fluctuation within complete dosing interval at steady state of total IgG was reported. Both baseline corrected and un-corrected data was reported. |
| Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Tetanus Toxoid Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Cmax was obtained directly from the concentration versus time curve. |
| Elimination Half-Life (t1/2) of Antigen-Specific Tetanus Toxoid Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. |
| Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Tetanus Toxoid Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. The AUC0-t of antigen-specific tetanus toxoid antibodies was measured in hour\*international units per milliliter (hr\*IU/mL). |
| Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Tetanus Toxoid Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. |
| Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Tetanus Toxoid Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule. |
| Volume of Distribution (Vd) of Antigen-Specific Tetanus Toxoid Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Vd was defined as the the theoretical volume in which the total amount of antigen-specific tetanus toxoid antibodies would need to be uniformly distributed to produce the desired blood concentration of antigen-specific tetanus toxoid antibodies. The Vd of antigen-specific tetanus toxoid antibodies was measured in milligrams\*milliliter per international unit\*kilogram (mg\*mL/IU\*kg). |
| Steady State Clearance (CLss) of Antigen-Specific Tetanus Toxoid Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Clearance of a antigen-specific tetanus toxoid antibodies was a measure of the rate at which a antigen-specific tetanus toxoid antibodies are metabolized or eliminated by normal biological processes. The CLss of antigen-specific tetanus toxoid antibodies was reported. The CLss of antigen-specific tetanus toxoid antibodies was measured in milligrams\*milliliter per hour\*international unit\*kilogram (mg\*mL/hr\*IU\*kg). |
| Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Tetanus Toxoid Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve. |
| Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Tetanus Toxoid Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Tmax was obtained directly from the concentration versus time curve. |
| Elimination Rate Constant (Kel) of Antigen-Specific Tetanus Toxoid Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. |
| Average Concentration of Antigen-Specific Tetanus Toxoid Antibodies Over the Dosing Interval (Cavg) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Average concentration of antigen-specific tetanus toxoid antibodies over the dosing interval (Cavg) was reported. |
| Percentage Peak Trough Fluctuation of Antigen-Specific Tetanus Toxoid Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | The peak trough fluctuation within complete dosing interval at steady state of antigen-specific tetanus toxoid antibodies was reported. |
| Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Cmax was obtained directly from the concentration versus time curve. |
| Elimination Half-Life (t1/2) of Antigen-Specific Haemophilus Influenza Type B Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. |
| Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Haemophilus Influenza Type B Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. AUC0-t of antigen-specific haemophilus influenza Type B Antibodies was measured in hour\*microgram per milliliter (hr\*mcg/mL). |
| Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Haemophilus Influenza Type B Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. |
| Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Haemophilus Influenza Type B Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule. |
| Volume of Distribution (Vd) of Antigen-Specific Haemophilus Influenza Type B Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Vd was defined as the the theoretical volume in which the total amount of antigen-specific haemophilus influenza type B antibodies would need to be uniformly distributed to produce the desired blood concentration of a antigen-specific haemophilus influenza type B antibodies. |
| Steady State Clearance (CLss) of Antigen-Specific Haemophilus Influenza Type B Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Clearance of antigen-specific haemophilus influenza type B antibodies was a measure of the rate at which antigen-specific haemophilus influenza type B antibodies were metabolized or eliminated by normal biological processes. CLss of antigen-specific haemophilus influenza type B antibodies was measured in milliliter per hour per kilogram (mL/hr/kg). |
| Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Haemophilus Influenza Type B Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve. |
| Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Tmax was obtained directly from the concentration versus time curve. |
| Terminal Elimination Rate Constant (Lambda z) of Antigen-Specific Haemophilus Influenza Type B Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Terminal Elimination Rate Constant (lambda z) derived if data allowed based on PK acceptance criteria |
| Average Concentration of Antigen-Specific Haemophilus Influenza Type B Antibodies Over the Dosing Interval (Cavg) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Average concentration of antigen-specific haemophilus influenza type B antibodies over the dosing interval (Cavg) was reported. |
| Percentage Peak Trough Fluctuation of Antigen-Specific Haemophilus Influenza Type B Antibodies | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | The peak trough fluctuation within complete dosing interval at steady state of antigen-specific haemophilus influenza type B antibodies was reported. |
| Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Cmax was obtained directly from the concentration versus time curve. The Cmax for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8, serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule. |
| Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The t1/2 for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule. |
| Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. AUC0-t of antigen-pneumococcal capsular polysaccharide was measured in hour\*microgram per milliliter (hr\*mcg/mL). The AUC0-t for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule. |
| Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The AUC0-inf for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20 serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule. |
| Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule. The AUCtau for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule. |
| Volume of Distribution (Vd) of of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Vd was defined as the the theoretical volume in which the total amount of anti-pneumococcal capsular polysaccharide would need to be uniformly distributed to produce the desired blood concentration of a anti-pneumococcal capsular polysaccharide. The Vd for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule. |
| Steady State Clearance (CLss) of Anti-pneumococcal Capsular Polysaccharide Antibodies (Overall SP Serotypes) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Clearance of a anti-pneumococcal capsular polysaccharide antibodies was a measure of the rate at which a anti-pneumococcal capsular polysaccharide antibodies are metabolized or eliminated by normal biological processes. The CLss of anti-pneumococcal capsular polysaccharide antibodies was reported. The CLss of anti-pneumococcal capsular polysaccharide antibodies was measured in milligrams\*milliliter per hour\*international unit\*kilogram (mg\*mL/hr\*IU\*kg). The CLss for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule. |
| Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve. The Cmin for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule. |
| Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Tmax was obtained directly from the concentration versus time curve. The Tmax for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule. |
| Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The Kel for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20 serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule. |
| Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | Average concentration of anti-pneumococcal capsular polysaccharide over the dosing interval (Cavg) was reported. The Cavg for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule. |
| Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion | The peak trough fluctuation within complete dosing interval at steady state of anti-pneumococcal capsular polysaccharide was reported. The peak trough fluctuation for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMedical Director
Kedrion SpA
Participant flow
Recruitment details
This study was conducted at 11 sites in the United States from 30 April 2019 (first participant first visit) to 21 December 2020 (last participant last visit).
Pre-assignment details
A total of 59 participants were screened, out of which 47 participants were enrolled and received the treatment in this study.
Participants by arm
| Arm | Count |
|---|---|
| Kedrion IVIG 10% 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. | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | Kedrion IVIG 10% |
|---|---|
| Age, Continuous | 52.6 years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized Mexican | 1 Participants |
| Race/Ethnicity, Customized White | 45 Participants |
| Race/Ethnicity, Customized White and African American | 1 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 38 / 47 |
| serious Total, serious adverse events | 4 / 47 |
Outcome results
Primary
Incidence Rate of Acute Serious Bacterial Infections (ABSIs)
Incidence rate was defined as the mean number of acute serious bacterial infections (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) per participant-year according to pre-specified criteria.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Incidence Rate of Acute Serious Bacterial Infections (ABSIs) | 21-day dosing schedule | 0.0 infections per participant-year | Standard Deviation 0 |
| Kedrion IVIG 10% | Incidence Rate of Acute Serious Bacterial Infections (ABSIs) | 28-day dosing schedule | 0.0 infections per participant-year | Standard Deviation 0 |
Secondary
Anti-Haemophilus Influenza Type B Antibody Levels
The anti-haemophilus influenza type B antibody levels were collected and analyzed at central laboratory.
Time frame: Baseline, Weeks 16, 32 and 48 (28 -day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Anti-Haemophilus Influenza Type B Antibody Levels | 28-day dosing schedule: Week 32 | 2.277 micrograms per milliliter (mcg/mL) | Standard Deviation 1.3112 |
| Kedrion IVIG 10% | Anti-Haemophilus Influenza Type B Antibody Levels | 21-day dosing schedule: Week 30 | 2.888 micrograms per milliliter (mcg/mL) | Standard Deviation 0.8676 |
| Kedrion IVIG 10% | Anti-Haemophilus Influenza Type B Antibody Levels | Baseline | 2.010 micrograms per milliliter (mcg/mL) | Standard Deviation 1.1641 |
| Kedrion IVIG 10% | Anti-Haemophilus Influenza Type B Antibody Levels | 28-day dosing schedule: Week 16 | 2.547 micrograms per milliliter (mcg/mL) | Standard Deviation 1.7879 |
| Kedrion IVIG 10% | Anti-Haemophilus Influenza Type B Antibody Levels | 21-day dosing schedule: Week 18 | 2.489 micrograms per milliliter (mcg/mL) | Standard Deviation 0.9027 |
| Kedrion IVIG 10% | Anti-Haemophilus Influenza Type B Antibody Levels | 28-day dosing schedule: Week 48 | 2.183 micrograms per milliliter (mcg/mL) | Standard Deviation 1.1944 |
| Kedrion IVIG 10% | 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
Anti-Measles Antibody Levels
The anti-measles antibody levels were collected and analyzed at a central laboratory.
Time frame: Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)
Population: As per change in planned analysis, the anti-measles antibody level test was not performed.
Secondary
Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
Anti-pneumococcal capsular polysaccharide antibody levels for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 were collected and analyzed at a central laboratory.
Time frame: Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 68 | 1.08 milligrams per liter (mg/L) | Standard Deviation 1.095 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 1 | 2.66 milligrams per liter (mg/L) | Standard Deviation 4.82 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 18: Serotype 1 | 4.89 milligrams per liter (mg/L) | Standard Deviation 5.74 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 12 | 0.81 milligrams per liter (mg/L) | Standard Deviation 1.103 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 28-day dosing schedule: Week 16: Serotype 12 | 0.75 milligrams per liter (mg/L) | Standard Deviation 1.201 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 28-day dosing schedule: Week 32: Serotype 12 | 0.86 milligrams per liter (mg/L) | Standard Deviation 1.28 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 30: Serotype 12 | 0.55 milligrams per liter (mg/L) | Standard Deviation 0.12 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 48: Serotype 12 | 0.59 milligrams per liter (mg/L) | Standard Deviation 0.09 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 14 | 9.04 milligrams per liter (mg/L) | Standard Deviation 20.383 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 17 | 2.55 milligrams per liter (mg/L) | Standard Deviation 4.249 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 18: Serotype 17 | 3.25 milligrams per liter (mg/L) | Standard Deviation 3.146 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 19 | 3.71 milligrams per liter (mg/L) | Standard Deviation 5.275 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 28-day dosing schedule: Week 32: Serotype 19 | 3.71 milligrams per liter (mg/L) | Standard Deviation 4.2 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 2 | 2.38 milligrams per liter (mg/L) | Standard Deviation 2.294 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 20 | 2.71 milligrams per liter (mg/L) | Standard Deviation 2.296 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 22 | 1.33 milligrams per liter (mg/L) | Standard Deviation 1.968 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 28-day dosing schedule: Week 16: Serotype 22 | 0.84 milligrams per liter (mg/L) | Standard Deviation 0.938 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 18: Serotype 22 | 2.36 milligrams per liter (mg/L) | Standard Deviation 3.554 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 28-day dosing schedule: Week 32: Serotype 22 | 0.83 milligrams per liter (mg/L) | Standard Deviation 0.698 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 28-day dosing schedule: Week 48: Serotype 22 | 0.88 milligrams per liter (mg/L) | Standard Deviation 0.67 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 23 | 1.65 milligrams per liter (mg/L) | Standard Deviation 2.336 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 28-day dosing schedule: Week 32: Serotype 23 | 1.37 milligrams per liter (mg/L) | Standard Deviation 2.064 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 28-day dosing schedule: Week 48: Serotype 23 | 1.47 milligrams per liter (mg/L) | Standard Deviation 2.27 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 26 | 1.72 milligrams per liter (mg/L) | Standard Deviation 1.91 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 18: Serotype 26 | 1.83 milligrams per liter (mg/L) | Standard Deviation 2.05 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 3 | 2.41 milligrams per liter (mg/L) | Standard Deviation 5.964 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 30: Serotype 3 | 4.24 milligrams per liter (mg/L) | Standard Deviation 6.48 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 48: Serotype 3 | 4.69 milligrams per liter (mg/L) | Standard Deviation 7.854 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 34 | 1.83 milligrams per liter (mg/L) | Standard Deviation 2.663 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 30: Serotype 34 | 3.73 milligrams per liter (mg/L) | Standard Deviation 6.61 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 4 | 0.88 milligrams per liter (mg/L) | Standard Deviation 1.366 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 43 | 1.36 milligrams per liter (mg/L) | Standard Deviation 0.713 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 5 | 3.64 milligrams per liter (mg/L) | Standard Deviation 5.551 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 28-day dosing schedule: Week 16: Serotype 5 | 2.68 milligrams per liter (mg/L) | Standard Deviation 3.65 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 18: Serotype 5 | 6.56 milligrams per liter (mg/L) | Standard Deviation 9.39 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 48: Serotype 5 | 5.41 milligrams per liter (mg/L) | Standard Deviation 7.414 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 51 | 2.82 milligrams per liter (mg/L) | Standard Deviation 5.468 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 54 | 3.04 milligrams per liter (mg/L) | Standard Deviation 4.819 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 28-day dosing schedule: Week 16: Serotype 54 | 2.33 milligrams per liter (mg/L) | Standard Deviation 2.575 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 18: Serotype 54 | 5.04 milligrams per liter (mg/L) | Standard Deviation 6.363 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 48: Serotype 54 | 4.13 milligrams per liter (mg/L) | Standard Deviation 3.7 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 56 | 3.41 milligrams per liter (mg/L) | Standard Deviation 8.495 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 18: Serotype 56 | 5.84 milligrams per liter (mg/L) | Standard Deviation 9.97 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 28-day dosing schedule: Week 32: Serotype 56 | 2.17 milligrams per liter (mg/L) | Standard Deviation 5.089 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 57 | 5.73 milligrams per liter (mg/L) | Standard Deviation 8.398 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 30: Serotype 68 | 1.36 milligrams per liter (mg/L) | Standard Deviation 1.26 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 70 | 1.98 milligrams per liter (mg/L) | Standard Deviation 2.911 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 28-day dosing schedule: Week 16: Serotype 70 | 1.43 milligrams per liter (mg/L) | Standard Deviation 1.1 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 18: Serotype 70 | 3.56 milligrams per liter (mg/L) | Standard Deviation 5.36 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 28-day dosing schedule: Week 48: Serotype 70 | 1.48 milligrams per liter (mg/L) | Standard Deviation 0.988 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 8 | 2.10 milligrams per liter (mg/L) | Standard Deviation 2.65 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 18: Serotype 8 | 3.51 milligrams per liter (mg/L) | Standard Deviation 3.44 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | Baseline: Serotype 9 | 0.96 milligrams per liter (mg/L) | Standard Deviation 0.694 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 28-day dosing schedule: Week 16: Serotype 9 | 0.77 milligrams per liter (mg/L) | Standard Deviation 0.51 |
| Kedrion IVIG 10% | Anti-Pneumococcal Capsular Polysaccharide Antibody Levels | 21-day dosing schedule: Week 18: Serotype 9 | 1.03 milligrams per liter (mg/L) | Standard Deviation 0.56 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
Secondary
Anti-Tetanus Toxoid Antibody Levels
The anti-tetanus toxoid antibody levels were collected and analyzed at a central laboratory. This antibody level was measured in international units per milliliter (IU/mL).
Time frame: Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Anti-Tetanus Toxoid Antibody Levels | Baseline | 2.526 IU/mL | Standard Deviation 1.4158 |
| Kedrion IVIG 10% | Anti-Tetanus Toxoid Antibody Levels | 28-day dosing schedule: Week 16 | 2.589 IU/mL | Standard Deviation 2.077 |
| Kedrion IVIG 10% | Anti-Tetanus Toxoid Antibody Levels | 21-day dosing schedule: Week 18 | 2.654 IU/mL | Standard Deviation 0.9853 |
| Kedrion IVIG 10% | Anti-Tetanus Toxoid Antibody Levels | 28-day dosing schedule: Week 32 | 2.345 IU/mL | Standard Deviation 0.882 |
| Kedrion IVIG 10% | Anti-Tetanus Toxoid Antibody Levels | 21-day dosing schedule: Week 30 | 2.643 IU/mL | Standard Deviation 0.9374 |
| Kedrion IVIG 10% | Anti-Tetanus Toxoid Antibody Levels | 28-day dosing schedule: Week 48 | 2.207 IU/mL | Standard Deviation 0.8565 |
| Kedrion IVIG 10% | Anti-Tetanus Toxoid Antibody Levels | 21-day dosing schedule: Week 48 | 3.299 IU/mL | Standard Deviation 1.3307 |
Secondary
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Haemophilus Influenza Type B Antibodies
AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Tetanus Toxoid Antibodies
AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule. The AUCtau for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 311.3335 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Total IgG
AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule. Both baseline corrected and un-corrected data was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, number analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Haemophilus Influenza Type B Antibodies
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Tetanus Toxoid Antibodies
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The AUC0-inf for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20 serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total IgG
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Kel, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. AUC0-t of antigen-specific haemophilus influenza Type B Antibodies was measured in hour\*microgram per milliliter (hr\*mcg/mL).
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Tetanus Toxoid Antibodies
Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. The AUC0-t of antigen-specific tetanus toxoid antibodies was measured in hour\*international units per milliliter (hr\*IU/mL).
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. AUC0-t of antigen-pneumococcal capsular polysaccharide was measured in hour\*microgram per milliliter (hr\*mcg/mL). The AUC0-t for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 2326.2759 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 10426.0505 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 66.0738 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 956.156 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Total IgG
Area under the serum concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. Both baseline corrected and un-corrected data was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, number analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Average Concentration of Antigen-Specific Haemophilus Influenza Type B Antibodies Over the Dosing Interval (Cavg)
Average concentration of antigen-specific haemophilus influenza type B antibodies over the dosing interval (Cavg) was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Average Concentration of Antigen-Specific Tetanus Toxoid Antibodies Over the Dosing Interval (Cavg)
Average concentration of antigen-specific tetanus toxoid antibodies over the dosing interval (Cavg) was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
Average concentration of anti-pneumococcal capsular polysaccharide over the dosing interval (Cavg) was reported. The Cavg for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 1.0916 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 0.2103 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Average Concentration of Total IgG Over the Dosing Interval (Cavg)
Average concentration of total IgG over the dosing interval (Cavg) was reported. Both baseline corrected and un-corrected data was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule)/7th infusion (21-day infusion schedule). This set included all participants following principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, number analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Average Concentration of Total IgG Over the Dosing Interval (Cavg) | Baseline corrected: 28-day dosing schedule: Week 16 | 354 mg/dL | Standard Deviation 117 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Average Concentration of Total IgG Over the Dosing Interval (Cavg) | Baseline uncorrected: 28-day dosing schedule: Week 16 | 1370 mg/dL | Standard Deviation 239 |
| Kedrion IVIG 10% | 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
Duration of Any Infection Other Than Acute Serious Bacterial Infections
Duration of any infection other than serious acute bacterial infections (in days) was calculated as date of stop of infection - date of start of infection + 1. Duration of any infection other than serious acute bacterial infections collected by the by the participant/participants parent(s)/legal guardian(s) in the participant diary or during clinic visit was reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Duration of Any Infection Other Than Acute Serious Bacterial Infections | 21-day dosing schedule | 42.9 days | Standard Deviation 66.66 |
| Kedrion IVIG 10% | Duration of Any Infection Other Than Acute Serious Bacterial Infections | 28-day dosing schedule | 25.3 days | Standard Deviation 52.14 |
Secondary
Duration of Fever Episodes in Participants
Duration of fever episodes in participants was reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Duration of Fever Episodes in Participants | 28-day dosing schedule | 3.0 days | Standard Deviation 2.24 |
| Unknown | Duration of Fever Episodes in Participants | 21-day dosing schedule | — days | — |
Secondary
Duration of Missed School/Work/Other Major Activities Due to Infections
Duration of missed school/work/other major activities due to infections was reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Duration of Missed School/Work/Other Major Activities Due to Infections | 21-day dosing schedule | 25.3 days | Standard Deviation 25.11 |
| Kedrion IVIG 10% | Duration of Missed School/Work/Other Major Activities Due to Infections | 28-day dosing schedule | 4.7 days | Standard Deviation 2.73 |
Secondary
Duration of Overall Participants Hospitalization
Duration of overall participants hospitalization was reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Duration of Overall Participants Hospitalization | 21-day dosing schedule | 6.0 days | — |
| Kedrion IVIG 10% | Duration of Overall Participants Hospitalization | 28-day dosing schedule | 3.3 days | Standard Deviation 1.53 |
Secondary
Duration of Participants Hospitalization Due to Infection
Duration of participants hospitalization due to infection was reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
Secondary
Duration of Participants on Antibiotics for Treatment of Any Kind of Infection
Duration of participants on antibiotics for treatment of any kind of infection was reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Duration of Participants on Antibiotics for Treatment of Any Kind of Infection | 21-day dosing schedule | 13.1 days | Standard Deviation 5.72 |
| Kedrion IVIG 10% | Duration of Participants on Antibiotics for Treatment of Any Kind of Infection | 28-day dosing schedule | 13.3 days | Standard Deviation 35.86 |
Secondary
Elimination Half-Life (t1/2) of Antigen-Specific Haemophilus Influenza Type B Antibodies
t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time pointsas per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Antigen-Specific Haemophilus Influenza Type B Antibodies | 28-day dosing schedule: Week 16 | 682 hours | Standard Deviation 488 |
Secondary
Elimination Half-Life (t1/2) of Antigen-Specific Tetanus Toxoid Antibodies
t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Antigen-Specific Tetanus Toxoid Antibodies | 28-day dosing schedule: Week 16 | 618.97 hours | Standard Deviation 320.008 |
| Kedrion IVIG 10% | 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
Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The t1/2 for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 279.86 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 275.2 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 1 | 813.74 hours | — |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 14 | 1467.24 hours | — |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 2 | 860.60 hours | — |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 20 | 779.88 hours | — |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 26 | 900.44 hours | — |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 3 | 292.95 hours | — |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 5 | 825.99 hours | — |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 51 | 813.32 hours | — |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 54 | 754.20 hours | — |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 56 | 931.50 hours | — |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 68 | 259.63 hours | — |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 8 | 616.54 hours | — |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 9 | 890.30 hours | — |
Secondary
Elimination Half-Life (t1/2) of Total IgG
t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Kel. Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Total IgG | Baseline corrected: 28-day dosing schedule: Week 16 | 158 hours | Standard Deviation 48.4 |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Total IgG | Baseline corrected: 21-day dosing schedule: Week 18 | 107 hours | Standard Deviation 45.4 |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Total IgG | Baseline uncorrected: 28-day dosing schedule: Week 16 | 896 hours | Standard Deviation 269 |
| Kedrion IVIG 10% | Elimination Half-Life (t1/2) of Total IgG | Baseline uncorrected: 21-day dosing schedule: Week 18 | 587 hours | Standard Deviation 58.2 |
Secondary
Elimination Rate Constant (Kel) of Antigen-Specific Tetanus Toxoid Antibodies
Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Antigen-Specific Tetanus Toxoid Antibodies | 28-day dosing schedule: Week 16 | 0.0014 1/hour | Standard Deviation 0.00062 |
| Kedrion IVIG 10% | 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
Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. The Kel for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20 serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 1 | 0.0009 1/hour | — |
| Kedrion IVIG 10% | 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 0.0003 |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 14 | 0.0005 1/hour | — |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 2 | 0.0008 1/hour | — |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 20 | 0.0009 1/hour | — |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 26 | 0.0008 1/hour | — |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 3 | 0.0024 1/hour | — |
| Kedrion IVIG 10% | 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 0.0001 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 5 | 0.0008 1/hour | — |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 51 | 0.0009 1/hour | — |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 54 | 0.0009 1/hour | — |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 56 | 0.0007 1/hour | — |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 68 | 0.0027 1/hour | — |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) | 21-day dosing schedule: Week 18: Serotype 8 | 0.0011 1/hour | — |
| Kedrion IVIG 10% | 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
Elimination Rate Constant (Kel) of Total IgG
Kel was the elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. Both baseline corrected and un-corrected data was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Total IgG | Baseline corrected: 28-day dosing schedule: Week 16 | 0.0048 1/hour | Standard Deviation 0.00156 |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Total IgG | Baseline corrected: 21-day dosing schedule: Week 18 | 0.00743 1/hour | Standard Deviation 0.003 |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Total IgG | Baseline uncorrected: 28-day dosing schedule: Week 16 | 0.000845 1/hour | Standard Deviation 0.00027 |
| Kedrion IVIG 10% | Elimination Rate Constant (Kel) of Total IgG | Baseline uncorrected: 21-day dosing schedule: Week 18 | 0.00119 1/hour | Standard Deviation 0.000117 |
Secondary
Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
IgG subclasses levels (IgG1, IgG2, IgG3, IgG4) were collected and analyzed at a central laboratory.
Time frame: At baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG1: Baseline | 5.798 g/L | Standard Deviation 1.7504 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG1: 28-day dosing schedule: Week 16 | 5.605 g/L | Standard Deviation 1.6115 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG1: 21-day dosing schedule: Week 18 | 5.968 g/L | Standard Deviation 1.5094 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG1: 28-day dosing schedule: Week 32 | 5.679 g/L | Standard Deviation 1.3965 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG1: 21-day dosing schedule: Week 30 | 5.979 g/L | Standard Deviation 0.943 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG1: 28-day dosing schedule: Week 48 | 5.634 g/L | Standard Deviation 1.4139 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG1: 21-day dosing schedule: Week 48 | 6.210 g/L | Standard Deviation 0.943 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG2: Baseline | 3.527 g/L | Standard Deviation 0.9635 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG2: 28-day dosing schedule: Week 16 | 3.419 g/L | Standard Deviation 0.8803 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG2: 21-day dosing schedule: Week 18 | 4.113 g/L | Standard Deviation 1.0155 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG2: 28-day dosing schedule: Week 32 | 3.458 g/L | Standard Deviation 0.7705 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG2: 21-day dosing schedule: Week 30 | 4.079 g/L | Standard Deviation 0.4975 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG2: 28-day dosing schedule: Week 48 | 3.475 g/L | Standard Deviation 0.7848 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG2: 21-day dosing schedule: Week 48 | 4.234 g/L | Standard Deviation 0.5649 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG3: Baseline | 0.405 g/L | Standard Deviation 0.3109 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG3: 28-day dosing schedule: Week 16 | 0.351 g/L | Standard Deviation 0.3459 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG3: 21-day dosing schedule: Week 18 | 0.271 g/L | Standard Deviation 0.1239 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG3: 28-day dosing schedule: Week 32 | 0.352 g/L | Standard Deviation 0.3461 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG3: 21-day dosing schedule: Week 30 | 0.249 g/L | Standard Deviation 0.0885 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG3: 28-day dosing schedule: Week 48 | 0.329 g/L | Standard Deviation 0.3268 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG3: 21-day dosing schedule: Week 48 | 0.253 g/L | Standard Deviation 0.0658 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG4: Baseline | 0.2213 g/L | Standard Deviation 0.12779 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG4: 28-day dosing schedule: Week 16 | 0.2388 g/L | Standard Deviation 0.09656 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG4: 21-day dosing schedule: Week 18 | 0.2744 g/L | Standard Deviation 0.06415 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG4: 28-day dosing schedule: Week 32 | 0.2425 g/L | Standard Deviation 0.0929 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG4: 21-day dosing schedule: Week 30 | 0.2838 g/L | Standard Deviation 0.06412 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG4: 28-day dosing schedule: Week 48 | 0.2396 g/L | Standard Deviation 0.09355 |
| Kedrion IVIG 10% | Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) | IgG4: 21-day dosing schedule: Week 48 | 0.2950 g/L | Standard Deviation 0.05381 |
Secondary
Incidence Rate of Antibiotics Episodes for Treatment of Any Kind of Infections
Incidence rate was defined as the mean number of antibiotics episodes per participant year. Incidence rate of participants on antibiotics for treatment of any kind of infections was reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Incidence Rate of Any Infection Other Than Acute Serious Bacterial Infections
Incidence rate was defined as the mean number of any infection other than acute serious bacterial infections (bacterial pneumonia, bacteraemia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) per participant-year. Incidence rate of any infection other than acute bacterial serious infections collected by the participant/participants parent(s)/legal guardian(s) in the participant diary or during clinic visit was reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Incidence Rate of Fever Episodes
Incidence rate was defined as the mean number of fever episodes per participant-year. Incidence rate of fever episodes collected by the participant/participant's parent(s)/legal guardian(s) in the participant diary or during clinic visit were reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Incidence Rate of Fever Episodes | 21-day dosing schedule | 0.0 fever episodes per participant year | Standard Deviation 0 |
| Kedrion IVIG 10% | Incidence Rate of Fever Episodes | 28-day dosing schedule | 0.2 fever episodes per participant year | Standard Deviation 0.42 |
Secondary
Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Cmax was obtained directly from the concentration versus time curve.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Tetanus Toxoid Antibodies
Cmax was obtained directly from the concentration versus time curve.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Cmax was obtained directly from the concentration versus time curve. The Cmax for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8, serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: Pharmacokinetic (PK) Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule)/7th infusion (21-day infusion schedule). This set included all participants following principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 4.551 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 1.615 |
| Kedrion IVIG 10% | 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 0.241 |
| Kedrion IVIG 10% | 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 0.994 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 1.608 |
| Kedrion IVIG 10% | 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 2.66 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 4.093 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 4.637 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 0.862 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 19.338 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
Secondary
Maximum Observed Serum Concentration (Cmax) of Total Immunoglobulin G (IgG)
Cmax was obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: Pharmacokinetic (PK) Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule)/7th infusion (21-day infusion schedule). This set included all participants following principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, number analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Tetanus Toxoid Antibodies
Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve. The Cmin for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, number analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 0.66 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 6.728 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 0.439 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 0.255 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 0.866 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 0.563 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 1.57 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Minimum Observed Serum Concentration (Cmin) of Total IgG
Cmin was minimum observed serum concentration obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, number analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Minimum Observed Serum Concentration (Cmin) of Total IgG | Baseline uncorrected: 21-day dosing schedule: Week 18 | 1140 mg/dL | Standard Deviation 150 |
| Kedrion IVIG 10% | Minimum Observed Serum Concentration (Cmin) of Total IgG | Baseline corrected: 28-day dosing schedule: Week 16 | 0.00 mg/dL | Standard Deviation 0 |
| Kedrion IVIG 10% | Minimum Observed Serum Concentration (Cmin) of Total IgG | Baseline corrected: 21-day dosing schedule: Week 18 | 0.00 mg/dL | Standard Deviation 0 |
| Kedrion IVIG 10% | Minimum Observed Serum Concentration (Cmin) of Total IgG | Baseline uncorrected: 28-day dosing schedule: Week 16 | 994 mg/dL | Standard Deviation 200 |
Secondary
Number of Drug Related Infusion Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Number of drug related infusion AEs were reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Kedrion IVIG 10% | Number of Drug Related Infusion Adverse Events (AEs) | 21-day dosing schedule | 3 adverse events |
| Kedrion IVIG 10% | Number of Drug Related Infusion Adverse Events (AEs) | 28-day dosing schedule | 60 adverse events |
Secondary
Number of Infusions With Decreased Infusion Rate Due to Adverse Events (AEs)
Number of infusions with decreased infusion rate due to AEs were reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Kedrion IVIG 10% | Number of Infusions With Decreased Infusion Rate Due to Adverse Events (AEs) | 28-day dosing schedule | 9 Infusions |
| Kedrion IVIG 10% | Number of Infusions With Decreased Infusion Rate Due to Adverse Events (AEs) | 21-day dosing schedule | 0 Infusions |
Secondary
Number of Infusions With One or More Infusion Associated Adverse Events (AEs)
The number of infusions with one or more infusion associated AEs were reported collectively for 21 and 28-day dosing schedule up to Week 52.
Time frame: Baseline up to Week 52
Population: The SAF included all participants who have received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Kedrion IVIG 10% | Number of Infusions With One or More Infusion Associated Adverse Events (AEs) | 80 Infusions |
Secondary
Number of Participants With Abnormal Plasma-free Haemoglobin Level
Number of participants with plasma-free haemoglobin level more than or equal to (\>=) 69 milligrams per deciliter (mg/dL) were consisdered as abormal and were reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kedrion IVIG 10% | Number of Participants With Abnormal Plasma-free Haemoglobin Level | 28-day dosing schedule: Week 16 | 10 Participants |
| Kedrion IVIG 10% | Number of Participants With Abnormal Plasma-free Haemoglobin Level | 21-day dosing schedule : Week 18 | 2 Participants |
Secondary
Number of Participants With Abnormal Serum Haptoglobin Level
Number of participants with abnormal serum haptoglobin level were reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kedrion IVIG 10% | Number of Participants With Abnormal Serum Haptoglobin Level | 28-day dosing schedule: Week 16 | 10 Participants |
| Kedrion IVIG 10% | Number of Participants With Abnormal Serum Haptoglobin Level | 21-day dosing schedule: Week 18 | 0 Participants |
Secondary
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
Laboratory parameters included chemistry, hematology and urinalysis. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in laboratory parameters were reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kedrion IVIG 10% | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters | Hematology: 21-day dosing schedule | 3 Participants |
| Kedrion IVIG 10% | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters | Hematology: 28-day dosing schedule | 7 Participants |
| Kedrion IVIG 10% | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters | Chemistry: 21-day dosing schedule | 1 Participants |
| Kedrion IVIG 10% | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters | Chemistry: 28-day dosing schedule | 5 Participants |
| Kedrion IVIG 10% | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters | Urinalysis: 21-day dosing schedule | 2 Participants |
| Kedrion IVIG 10% | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters | Urinalysis: 28-day dosing schedule | 4 Participants |
Secondary
Number of Participants With Clinically Significant Changes From Baseline in Physical Examinations
Physical examination included the examination of general appearance, skin, neck, eyes, ears, nose, throat, cardiovascular assessment including rhythm, and presence of other cardiac abnormalities (for example gallops, murmurs, cardiomegaly), respiratory system, gastrointestinal system, genitourinary system and musculoskeletal system. Clinical significance was decided by the investigator. The number of participants with clinically significant changes from baseline in physical examination were reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kedrion IVIG 10% | Number of Participants With Clinically Significant Changes From Baseline in Physical Examinations | 21-day dosing schedule | 0 Participants |
| Kedrion IVIG 10% | Number of Participants With Clinically Significant Changes From Baseline in Physical Examinations | 28-day dosing schedule | 0 Participants |
Secondary
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Vital signs included body temperature, systolic and diastolic blood pressure, heart rate and weight. The systolic and diastolic blood pressure and pulse rate was measured after the participants have in a rested at least 3 minutes in seated position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in vital signs were reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kedrion IVIG 10% | Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | 21-day dosing schedule | 0 Participants |
| Kedrion IVIG 10% | Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | 28-day dosing schedule | 0 Participants |
Secondary
Number of Participants With Positive Coomb's Test at Week 16 (28-day Dosing Schedule) and Week 18 (21-day Dosing Schedule)
Intravascular hemolysis testing was performed by using coomb's test. The coomb's assessment was performed at a central laboratory.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Number of Participants With Positive Urine Hemosiderin Test
Number of participants with positive urine hemosiderin test were reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kedrion IVIG 10% | Number of Participants With Positive Urine Hemosiderin Test | 28-day dosing schedule: Week 16 | 0 Participants |
| Kedrion IVIG 10% | Number of Participants With Positive Urine Hemosiderin Test | 21-day dosing schedule: Week 18 | 0 Participants |
Secondary
Number of Participants With Total Immunoglobulin G (IgG) Trough Levels Less Than or Equal to (<=) 6 Grams/Liter (g/L) Criteria
Number of participants with Total IgG trough levels \<= 6 g/L criteria were reported.
Time frame: Up to 12 months
Population: FAS included all participants who have received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Kedrion IVIG 10% | Number of Participants With Total Immunoglobulin G (IgG) Trough Levels Less Than or Equal to (<=) 6 Grams/Liter (g/L) Criteria | 1 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAE was defined as an AE with an onset that occurs after receiving study drug. Any TEAE included participants with both serious and non-serious TEAEs.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kedrion IVIG 10% | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Participants with TEAEs: 21-day dosing schedule: | 8 Participants |
| Kedrion IVIG 10% | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Participants with TEAEs: 28-day dosing schedule | 38 Participants |
| Kedrion IVIG 10% | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Participants with Serious TEAEs: 21-day dosing schedule | 1 Participants |
| Kedrion IVIG 10% | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Participants with Serious TEAEs: 28-day dosing schedule | 3 Participants |
Secondary
Number of TEAEs and Serious TEAEs
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. A SAE was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. A TEAE was defined as an AE with an onset that occurs after receiving study drug. Number of TEAEs and Serious TEAEs were reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Kedrion IVIG 10% | Number of TEAEs and Serious TEAEs | TEAEs: 21-day dosing schedule | 79 adverse events |
| Kedrion IVIG 10% | Number of TEAEs and Serious TEAEs | TEAEs: 28-day dosing schedule | 324 adverse events |
| Kedrion IVIG 10% | Number of TEAEs and Serious TEAEs | Serious TEAEs: 21-day dosing schedule | 1 adverse events |
| Kedrion IVIG 10% | Number of TEAEs and Serious TEAEs | Serious TEAEs: 28-day dosing schedule | 4 adverse events |
Secondary
Pediatric Quality of Life Inventory (PedsQL) Score
23-item PedsQL generic core scales was a modular approach to measure health-related Quality of Life (QoL) in healthy children, adolescents and those with acute and chronic health conditions. The total scale score (23 items) consisted of Physical Health Summary Score (8 items) and Psychosocial Health SummaryScore (15 items). Physical health summary included Physical Functioning (8 items) and Psychosocial health summary score included Emotional Functioning (5 items), Social Functioning (5 items) and School Functioning (5 items). Items were scored on a 5 point Likert-type response scale: 0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; and 4=almost always a problem). Once scored, items were reverse scored and linearly transformed to a 0-100 scale, where higher scores indicated better QoL. The overall range for total PedsQL score (23 items) was 0 to 100, with higher score indicated better QoL. Data for 18-25 years and \>25 years age group was reported.
Time frame: Baseline, Week 24 (21-day dosing schedule and 28-day dosing schedule), Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Pediatric Quality of Life Inventory (PedsQL) Score | 28-day dosing schedule: Week 24 (18 to 25 years) | 100.0 score on a scale | — |
| Kedrion IVIG 10% | Pediatric Quality of Life Inventory (PedsQL) Score | Baseline (18 to 25 years) | 87.5 score on a scale | Standard Deviation 16.14 |
| Kedrion IVIG 10% | Pediatric Quality of Life Inventory (PedsQL) Score | 21-day dosing schedule: Week 24 (18 to 25 years) | 68.5 score on a scale | — |
| Kedrion IVIG 10% | Pediatric Quality of Life Inventory (PedsQL) Score | 21-day dosing schedule: Week 51 (18 to 25 years) | 58.7 score on a scale | — |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | Pediatric Quality of Life Inventory (PedsQL) Score | 28-day dosing schedule: Week 52 (18 to 25 years) | 100.0 score on a scale | — |
| Kedrion IVIG 10% | Pediatric Quality of Life Inventory (PedsQL) Score | Baseline (> 25 years) | 76.2 score on a scale | Standard Deviation 16.53 |
Secondary
Percentage of Participants Who Experienced at Least One Drug Related Infusion Adverse Events (AEs)
Percentage of participants who experienced at least one drug related infusion AEs were reported.
Time frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Kedrion IVIG 10% | Percentage of Participants Who Experienced at Least One Drug Related Infusion Adverse Events (AEs) | 21-day dosing schedule | 25.0 percentage of participants |
| Kedrion IVIG 10% | Percentage of Participants Who Experienced at Least One Drug Related Infusion Adverse Events (AEs) | 28-day dosing schedule | 43.6 percentage of participants |
Secondary
Percentage Peak Trough Fluctuation of Antigen-Specific Haemophilus Influenza Type B Antibodies
The peak trough fluctuation within complete dosing interval at steady state of antigen-specific haemophilus influenza type B antibodies was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Percentage Peak Trough Fluctuation of Antigen-Specific Tetanus Toxoid Antibodies
The peak trough fluctuation within complete dosing interval at steady state of antigen-specific tetanus toxoid antibodies was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Percentage Peak Trough Fluctuation of Antigen-Specific Tetanus Toxoid Antibodies | 28-day dosing schedule: Week 16 | 154.7237 percent fluctuation | Standard Deviation 63.56527 |
| Kedrion IVIG 10% | 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
Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
The peak trough fluctuation within complete dosing interval at steady state of anti-pneumococcal capsular polysaccharide was reported. The peak trough fluctuation for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 65.7968 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 41.0338 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 43.8001 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 31.1555 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 31.2633 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 30.7733 |
Secondary
Percentage Peak Trough Fluctuation of Total IgG
The peak trough fluctuation within complete dosing interval at steady state of total IgG was reported. Both baseline corrected and un-corrected data was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, number analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Percentage Peak Trough Fluctuation of Total IgG | Baseline corrected: 28-day dosing schedule: Week 16 | 364 percent fluctuation | Standard Deviation 70.7 |
| Kedrion IVIG 10% | Percentage Peak Trough Fluctuation of Total IgG | Baseline corrected: 21-day dosing schedule: Week 18 | 360 percent fluctuation | Standard Deviation 56.3 |
| Kedrion IVIG 10% | Percentage Peak Trough Fluctuation of Total IgG | Baseline uncorrected: 28-day dosing schedule: Week 16 | 94.3 percent fluctuation | Standard Deviation 30.6 |
| Kedrion IVIG 10% | Percentage Peak Trough Fluctuation of Total IgG | Baseline uncorrected: 21-day dosing schedule: Week 18 | 95.0 percent fluctuation | Standard Deviation 7.92 |
Secondary
Serum Immunoglobulin G (IgG) Trough Levels
The serum IgG trough levels were collected and analyzed at a central laboratory.
Time frame: At baseline, Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Serum Immunoglobulin G (IgG) Trough Levels | Baseline | 10.317 grams per liter (g/L) | Standard Deviation 3.1342 |
| Kedrion IVIG 10% | Serum Immunoglobulin G (IgG) Trough Levels | 21-day dosing schedule: Week 51 | 11.433 grams per liter (g/L) | Standard Deviation 1.7935 |
| Kedrion IVIG 10% | Serum Immunoglobulin G (IgG) Trough Levels | 28-day dosing schedule: Week 52 | 10.297 grams per liter (g/L) | Standard Deviation 2.1167 |
Secondary
Steady State Clearance (CLss) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Clearance of antigen-specific haemophilus influenza type B antibodies was a measure of the rate at which antigen-specific haemophilus influenza type B antibodies were metabolized or eliminated by normal biological processes. CLss of antigen-specific haemophilus influenza type B antibodies was measured in milliliter per hour per kilogram (mL/hr/kg).
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Steady State Clearance (CLss) of Antigen-Specific Tetanus Toxoid Antibodies
Clearance of a antigen-specific tetanus toxoid antibodies was a measure of the rate at which a antigen-specific tetanus toxoid antibodies are metabolized or eliminated by normal biological processes. The CLss of antigen-specific tetanus toxoid antibodies was reported. The CLss of antigen-specific tetanus toxoid antibodies was measured in milligrams\*milliliter per hour\*international unit\*kilogram (mg\*mL/hr\*IU\*kg).
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Steady State Clearance (CLss) of Anti-pneumococcal Capsular Polysaccharide Antibodies (Overall SP Serotypes)
Clearance of a anti-pneumococcal capsular polysaccharide antibodies was a measure of the rate at which a anti-pneumococcal capsular polysaccharide antibodies are metabolized or eliminated by normal biological processes. The CLss of anti-pneumococcal capsular polysaccharide antibodies was reported. The CLss of anti-pneumococcal capsular polysaccharide antibodies was measured in milligrams\*milliliter per hour\*international unit\*kilogram (mg\*mL/hr\*IU\*kg). The CLss for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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
Steady State Clearance (CLss) of Total IgG
Clearance of a total IgG was a measure of the rate at which a total IgG is metabolized or eliminated by normal biological processes. CLss of total IgG was measured in milliliters per hour per kilogram (mL/hr/kg). Both baseline corrected and un-corrected data was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | Steady State Clearance (CLss) of Total IgG | Baseline corrected: 28-day dosing schedule: Week 16 | 0.0559 dL/day/kg | Standard Deviation 0.0102 |
| Kedrion IVIG 10% | Steady State Clearance (CLss) of Total IgG | Baseline corrected: 21-day dosing schedule: Week 18 | 0.0763 dL/day/kg | Standard Deviation 0.00342 |
| Kedrion IVIG 10% | Steady State Clearance (CLss) of Total IgG | Baseline uncorrected: 28-day dosing schedule: Week 16 | 0.0140 dL/day/kg | Standard Deviation 0.00355 |
| Kedrion IVIG 10% | 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
Terminal Elimination Rate Constant (Lambda z) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Terminal Elimination Rate Constant (lambda z) derived if data allowed based on PK acceptance criteria
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
Secondary
Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Tmax was obtained directly from the concentration versus time curve.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
Secondary
Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Tetanus Toxoid Antibodies
Tmax was obtained directly from the concentration versus time curve.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Kedrion IVIG 10% | Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Tetanus Toxoid Antibodies | 28-day dosing schedule: Week 16 | 2.000 hours |
| Kedrion IVIG 10% | Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Tetanus Toxoid Antibodies | 21-day dosing schedule: Week 18 | 70.450 hours |
Secondary
Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Tmax was obtained directly from the concentration versus time curve. The Tmax for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
Secondary
Time to Reach the Maximum Serum Concentration (Tmax) of Total IgG
Tmax was obtained directly from the concentration versus time curve. Both baseline corrected and un-corrected data was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK Evaluation Set: all adult participants that consent to this part of protocol and who have PK analysis performed at 5th infusion (28-day infusion schedule) or 7th infusion (21-day infusion schedule). This set included all participants following the principles of SAF for whom at least 1 concentration of total IgGs, IgG subclasses 1-4/IgG specific antibody levels. Here, number analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Kedrion IVIG 10% | Time to Reach the Maximum Serum Concentration (Tmax) of Total IgG | Baseline corrected: 28-day dosing schedule: Week 16 | 0.515 hours |
| Kedrion IVIG 10% | Time to Reach the Maximum Serum Concentration (Tmax) of Total IgG | Baseline corrected: 21-day dosing schedule: Week 18 | 0.530 hours |
| Kedrion IVIG 10% | Time to Reach the Maximum Serum Concentration (Tmax) of Total IgG | Baseline uncorrected: 28-day dosing schedule: Week 16 | 0.515 hours |
| Kedrion IVIG 10% | Time to Reach the Maximum Serum Concentration (Tmax) of Total IgG | Baseline uncorrected: 21-day dosing schedule: Week 18 | 0.530 hours |
Secondary
Volume of Distribution (Vd) of Antigen-Specific Haemophilus Influenza Type B Antibodies
Vd was defined as the the theoretical volume in which the total amount of antigen-specific haemophilus influenza type B antibodies would need to be uniformly distributed to produce the desired blood concentration of a antigen-specific haemophilus influenza type B antibodies.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 88143.8419 |
Secondary
Volume of Distribution (Vd) of Antigen-Specific Tetanus Toxoid Antibodies
Vd was defined as the the theoretical volume in which the total amount of antigen-specific tetanus toxoid antibodies would need to be uniformly distributed to produce the desired blood concentration of antigen-specific tetanus toxoid antibodies. The Vd of antigen-specific tetanus toxoid antibodies was measured in milligrams\*milliliter per international unit\*kilogram (mg\*mL/IU\*kg).
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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
Volume of Distribution (Vd) of of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
Vd was defined as the the theoretical volume in which the total amount of anti-pneumococcal capsular polysaccharide would need to be uniformly distributed to produce the desired blood concentration of a anti-pneumococcal capsular polysaccharide. The Vd for serotype 1, serotype 12, serotype 14, serotype 17, serotype 19, serotype 2, serotype 20, serotype 22, serotype 23, serotype 26, serotype 3, serotype 4, serotype 34, serotype 43, serotype 5, serotype 51, serotype 54, serotype 56, serotype 57, serotype 68, serotype 70, serotype 8 and serotype 9 was reported at Week 16 during 28-day dosing schedule and at Week 18 during 21-day dosing schedule.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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 | — |
| Kedrion IVIG 10% | 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
Volume of Distribution (Vd) of Total IgG
Vd was defined as the the theoretical volume in which the total amount of total IgG would need to be uniformly distributed to produce the desired blood concentration of a total IgG. Both baseline corrected and un-corrected data was reported.
Time frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Population: PK evaluation set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time points as per dosing schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |
| Kedrion IVIG 10% | 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 |