Primary Immunodeficiency Diseases (PID)
Conditions
Brief summary
The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).
Interventions
Subcutaneous infusion with IGSC, 20%
Intravenous infusion with IGIV, 10%
Sponsors
Baxalta now part of Shire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Documented diagnosis of a form of primary humoral immunodeficiency involving defective antibody formation and requiring gammaglobulin replacement as defined according to the IUIS Scientific Committee, 2011 and by diagnostic criteria according to Conley et al. (1999). The diagnosis must be confirmed by the Medical Director prior to first treatment with the investigational product (IP) in the study. * Participant is 2 years or older at the time of screening, and has a minimum body weight of 13 kg. * Written informed consent has been obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration * Participant has been receiving a stable monthly equivalent dose of IgG at an average minimum dose equivalent to 300 mg/kg bodyweight (BW)/4 weeks and a maximum dose equivalent to 1.0 gram/kg BW/4 weeks, for a minimum of 12 weeks prior to first treatment with the IP in the study. * Serum trough level of IgG \> 500 mg/dL at screening * Participant is willing and able to comply with the requirements of the protocol Main
Exclusion criteria
* Participant has known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for Hepatitis C virus(HCV), PCR for human immunodeficiency virus (HIV) Type 1/2 * Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent): * Persistent alanine aminotransferase (ALT) and aspartate amino transferase(AST) \> 2.5 times the upper limit of normal for the testing laboratory * Persistent severe neutropenia (defined as an absolute neutrophil count \[ANC\] ≤500/mm\^3) * Creatinine clearance (CLcr) value that is \< 60% of normal for age and gender either measured, or calculated according to the Cockcroft-Gault formula * Malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), unless the disease-free period prior to screening exceeds 5 years * Participant is receiving anti-coagulation therapy (low dose aspirin at ≤325 mg/day is permitted) or has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) or sickle cell disease with crisis within 12 months prior to screening or a history of thrombophilia * Abnormal protein loss (protein losing enteropathy, nephrotic syndrome) * Anemia that would preclude phlebotomy for laboratory studies according to standard practice at the site * Acute serious bacterial infection within 3 months prior to screening * Ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following intravenous immunoglobulin, subcutaneous immunoglobulin, and/or Immune Serum Globulin (ISG) infusions * Severe immunoglobulin A (IgA) deficiency (less than 0.07g/L) with known anti-IgA antibodies and a history of hypersensitivity * Participant is on continuous systemic antibacterial antibiotics at doses sufficient to treat or prevent bacterial infections, and, in the opinion of the investigator, cannot stop these for the duration of the study without putting the patient at risk of increased infections * Participant has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening * Bleeding disorder or thrombocytopenia with a platelet count less than 20,000/μL, or who, in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of subcutaneous therapy * Total protein \> 9 g/dL or myeloma or macroglobulinemia (IgM) or paraproteinemia * Severe dermatitis that would preclude adequate sites for safe product administration * Women of childbearing potential meeting any one of the following criteria: * Participant presents with a positive pregnancy test * Participant is breast feeding * Participant intends to begin nursing during the course of the study * Participant does not agree to employ adequate birth-control measures (e.g. intrauterine device, diaphragm or condom \[for male partner\] with spermicidal jelly or foam, or birth control pills/patches) throughout the course of the study * Participation in another clinical study and exposure to an investigational product or device within 30 days prior to study enrollment (exception: treatment in a previous Baxter immunoglobulin study) * Participant is scheduled to participate in another (non-Baxter) non-observational (interventional) clinical study involving an investigational product or device during the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Acute Serious Bacterial Infections Per Year (ASBI) | 1 year | Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant. The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annual Rate of All Infections Per Participant | 1 year | — |
| Annual Rate of Sinus Infections Per Participant | 1 year | — |
| Annual Rate of Fever Episodes Per Participant | 1 year | — |
| Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant | 1 year | — |
| Annual Rate of Days on Antibiotics Per Participant | 1 year | — |
| Annual Rate of Hospitalizations for Illness or Infection Per Participant | 1 year | — |
| Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant | 1 year | — |
| Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant | 1 year | — |
| Bioavailability of IGSC, 20% as Measured by the Ratio of the Geometric Means of Immunoglobulin G (IgG) AUCSC (Epoch 4) to IgG AUCIV,0-τ (Standardized to 1 Week) (Epoch 1) Adjusted for Dose and Dosing Frequency (Participants ≥12 Years Old) | Epoch 1: 3 week IV administration interval: Week 10, 11, 12, 13. Epoch 1: 4 week IV interval: Week 9, 10, 11, 12, 13. Epoch 4 Subcutaneous administration weeks 17, 18 | IGSC, 20% = Immune Globulin Subcutaneous (Human), 20% Solution; AUCSC = area under the concentration-time curve following subcutaneous administration; AUCIV,0-τ = area under the concentration-time curve following intravenous administration over a dosing interval |
| Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | Epoch 1: 3 week IV interval- weeks 0, 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 0, 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2) | — |
| Trough Levels of Anti-Tetanus Antibody | Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2) | — |
| Trough Levels of Anti-Haemophilus Influenza B Antibody | Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2) | — |
| Trough Levels of Anti-Hepatitis B Antibody | Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2) | — |
| Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC) | Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 | The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) |
| Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC) | Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 | The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight. |
| Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax) | Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 | The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC). |
| Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax) | Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 | The minimum time (Tmax) to reach the maximum concentration (Cmax) |
| Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin) | Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 | The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC). |
| Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC) | Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 | The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week ) |
| Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC) | Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 | The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight. |
| Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously | Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 | Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0- τ). (F= bioavailability) |
| Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax) | Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 | The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC). |
| Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax) | Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 | The minimum time (Tmax) to reach the maximum concentration (Cmax) |
| Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin) | Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 | The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC). |
| Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | 29 weeks | There is a high degree of variability in catabolism of immunoglobulin G (IgG) between individuals. To address this, trough levels immediately prior to the 9th weekly infusion in Epoch 3 were measured. The ratio of the measured trough levels on subcutaneous (SC) (Epoch 3) and intravenous (IV) administration (Epoch1) were compared to the expected trough level determined in Epoch 2. This was used to determine the Individually Adapted Dose to be used in Epoch 4. This was an interim study analysis. |
| Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant | Up to 20 months per subject (throughout entire study) | Number of related SAEs and AEs divided by number of participants |
| Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion | Up to 20 months per subject (throughout entire study) | Number of related SAEs and AEs divided by number of subjects and divided by number of infusions |
| Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant | Up to 20 months per subject (throughout entire study) | Number of all SAEs and AEs divided by number of participants |
| Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion | Up to 20 months per subject (throughout entire study) | Number of all SAEs and AEs divided by number of infusions |
| Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant | Within 72 hours of completion of infusion | Number of AEs that begin during or within 72 hours of completion of infusion divided by number of participants |
| Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion | Within 72 hours of completion of infusion | Number of AEs that begin during or within 72 hours of completion of infusion divided by the number of infusions |
| Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant | Within 24 hours of completion of infusion | Number of AEs that begin during or within 24 hours of completion of infusion divided by number of participants |
| Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion | Within 24 hours of completion of infusion | Number of AEs that begin during or within 24 hours of completion of infusion divided by number of infusions |
| Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant | Within 1 hour of completion of infusion | Number of AEs that begin during or within 1 hour of completion of infusion divided by number of participants |
| Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion | Within 1 hour of completion of infusion | Number of AEs that begin during or within 1 hour of completion of infusion divided by number of infusions |
| Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion | Within 72 hours post infusion for Temporally Associated AEs; End of each Study Epoch (Epoch 1, Epoch 2, Epoch 3, and Epoch 4) for Causally Related AEs | The total number of all AEs (including and excluding infections) that begin during infusion or within 72 hours of completion of an infusion (temporally associated) plus the total number of AEs (including and excluding infections) starting more than 72 hours following the completion of an infusion determined by the investigator to be at least possibly related to the study drug(related), divided by the total number of infusions |
| Percentage of Infusions Associated With One or More Local Non-serious Adverse Events (Non-SAEs) | Up to 20 months (throughout entire study) | The number of infusions associated with local non-SAEs divided by the total number of infusions. |
| Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs) | Up to 20 months (throughout entire study) | — |
| Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs | Up to 20 months (throughout entire study) | — |
| Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs | Up to 20 months (throughout entire study) | — |
| Percentage of Infusions Tolerated With Intravenous or Subcutaneous Administration | Up to 20 months (throughout entire study) | An infusion will be deemed as tolerated unless one of the following occurs: 1. Any serious related AE(s) 2. Any non-serious local or systemic related AE(s) that prevent(s) completion of infusion 3. Any severe non-serious local or systemic related AE(s) that occur within 60 minutes of completion of the infusion |
| Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Up to 20 months (throughout entire study) | The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both sub-scores and summary scores. |
| Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC) | Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 | Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0-τ). (F= bioavailability) |
| Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
| Number of Participants With Laboratory Confirmed Hemolysis That Occurred Following Investigational Product Administration | Epoch 1: 3 week IV interval- weeks 0, 10. Epoch 1: 4 week IV interval- weeks 0, 9. Epoch 3: Subcutaneous (SC) week 9. Epoch 4: SC weeks 17, 18, 40 | Laboratory tests for confirmation of potential hemolysis include Coomb's test, haptoglobin, free hemoglobin, reticulocyte count, lactate dehydrogenase (LDH), and urine hemosiderin. |
| Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Up to 20 months (throughout entire study) | The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score. |
| Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Up to 20 months (throughout entire study) | The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score. |
| Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Up to 20 months per subject (throughout entire study) | TSQM; for the age group 2 to 12 years the observer will be a parent. Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain. |
| Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Up to 20 months per subject (throughout entire study) | TSQM; for the age group 13 years and older the observer will be the participant. Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain. |
| Life Quality Index - 2 to 12 Years Old | Up to 20 months (throughout entire study) | For the age group 2 to 12 years the respondent will be a parent. Each of the four domains has a separate score, each has a different range as follows: Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment. |
| Life Quality Index - 13 Years and Older | Up to 20 months per subject (throughout entire study) | For the age group 13 years and older the respondent will be the participant. Each of the four domains has a separate score, each has a different range as follows: Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment. |
| Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range. |
Countries
Canada, United States
Participant flow
Recruitment details
Participants were enrolled (signed informed consent) at 15 sites.
Pre-assignment details
A total of 86 participants provided informed consent. 9 of these participants did not start Epoch1, of which there were 6 screen failures; 2 were not able to receive their first infusion according to protocol timeline; and 1 withdrew. Therefore, 77 participants started Epoch 1 of the study.
Participants by arm
| Arm | Count |
|---|---|
| Study Epochs 1-4 \- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study. - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. | 77 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Epoch 1 | Adverse Event | 1 |
| Epoch 1 | Physician Decision | 2 |
| Epoch 3 | Adverse Event | 1 |
| Epoch 3 | Withdrawal by Subject | 3 |
| Epoch 4 | Physician Decision | 1 |
| Epoch 4 | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Study Epochs 1-4 |
|---|---|
| Age, Continuous | 36.0 Years |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 46 / 77 | 59 / 74 |
| serious Total, serious adverse events | 1 / 77 | 2 / 74 |
Outcome results
Primary
Rate of Acute Serious Bacterial Infections Per Year (ASBI)
Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant. The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit.
Time frame: 1 year
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Rate of Acute Serious Bacterial Infections Per Year (ASBI) | 0.012 Estimated infections/ year |
p-value: <0.0001Poisson
Secondary
Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant
Time frame: 1 year
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant | 1.73 Estimated visits/participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant | 0.86 Estimated visits/participant |
Secondary
Annual Rate of All Infections Per Participant
Time frame: 1 year
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Annual Rate of All Infections Per Participant | 3.86 Estimated infections/year |
| Subcutaneous 20% - Epochs 2 Thru 4 | Annual Rate of All Infections Per Participant | 2.41 Estimated infections/year |
Secondary
Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant
Time frame: 1 year
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant | 3.20 Estimated days off/participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant | 1.16 Estimated days off/participant |
Secondary
Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant
Time frame: 1 year
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant | 0.20 Estimated days/participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant | 0.11 Estimated days/participant |
Secondary
Annual Rate of Days on Antibiotics Per Participant
Time frame: 1 year
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Annual Rate of Days on Antibiotics Per Participant | 63.20 Estimated days/particpant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Annual Rate of Days on Antibiotics Per Participant | 57.59 Estimated days/particpant |
Secondary
Annual Rate of Fever Episodes Per Participant
Time frame: 1 year
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Annual Rate of Fever Episodes Per Participant | 0.61 Estimated episodes/year |
| Subcutaneous 20% - Epochs 2 Thru 4 | Annual Rate of Fever Episodes Per Participant | 0.13 Estimated episodes/year |
Secondary
Annual Rate of Hospitalizations for Illness or Infection Per Participant
Time frame: 1 year
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Annual Rate of Hospitalizations for Illness or Infection Per Participant | 0.05 Estimated hospitalizations/participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Annual Rate of Hospitalizations for Illness or Infection Per Participant | 0.02 Estimated hospitalizations/participant |
Secondary
Annual Rate of Sinus Infections Per Participant
Time frame: 1 year
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Annual Rate of Sinus Infections Per Participant | 0.97 Estimated infections/year |
| Subcutaneous 20% - Epochs 2 Thru 4 | Annual Rate of Sinus Infections Per Participant | 0.69 Estimated infections/year |
Secondary
Bioavailability of IGSC, 20% as Measured by the Ratio of the Geometric Means of Immunoglobulin G (IgG) AUCSC (Epoch 4) to IgG AUCIV,0-τ (Standardized to 1 Week) (Epoch 1) Adjusted for Dose and Dosing Frequency (Participants ≥12 Years Old)
IGSC, 20% = Immune Globulin Subcutaneous (Human), 20% Solution; AUCSC = area under the concentration-time curve following subcutaneous administration; AUCIV,0-τ = area under the concentration-time curve following intravenous administration over a dosing interval
Time frame: Epoch 1: 3 week IV administration interval: Week 10, 11, 12, 13. Epoch 1: 4 week IV interval: Week 9, 10, 11, 12, 13. Epoch 4 Subcutaneous administration weeks 17, 18
Population: Safety Analysis Set with correctly administered IGIV 10% dose in Epoch 1
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Study Participants | Bioavailability of IGSC, 20% as Measured by the Ratio of the Geometric Means of Immunoglobulin G (IgG) AUCSC (Epoch 4) to IgG AUCIV,0-τ (Standardized to 1 Week) (Epoch 1) Adjusted for Dose and Dosing Frequency (Participants ≥12 Years Old) | 1.0855 Ratio |
Secondary
Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion
The total number of all AEs (including and excluding infections) that begin during infusion or within 72 hours of completion of an infusion (temporally associated) plus the total number of AEs (including and excluding infections) starting more than 72 hours following the completion of an infusion determined by the investigator to be at least possibly related to the study drug(related), divided by the total number of infusions
Time frame: Within 72 hours post infusion for Temporally Associated AEs; End of each Study Epoch (Epoch 1, Epoch 2, Epoch 3, and Epoch 4) for Causally Related AEs
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion | Non-SAEs - Including infections | 0.336 Adverse events per infusion |
| Study Participants | Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion | Non-SAEs - Excluding infections | 0.309 Adverse events per infusion |
| Study Participants | Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion | SAEs - Including infections | 0.003 Adverse events per infusion |
| Study Participants | Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion | SAEs - Excluding infections | 0.003 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion | SAEs - Excluding infections | 0 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion | Non-SAEs - Including infections | 0.079 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion | SAEs - Including infections | 0 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion | Non-SAEs - Excluding infections | 0.064 Adverse events per infusion |
Secondary
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table)
There is a high degree of variability in catabolism of immunoglobulin G (IgG) between individuals. To address this, trough levels immediately prior to the 9th weekly infusion in Epoch 3 were measured. The ratio of the measured trough levels on subcutaneous (SC) (Epoch 3) and intravenous (IV) administration (Epoch1) were compared to the expected trough level determined in Epoch 2. This was used to determine the Individually Adapted Dose to be used in Epoch 4. This was an interim study analysis.
Time frame: 29 weeks
Population: Pharmacokinetics interim analysis set to determine the Individually Adapted Dose for Epoch 4
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 0.93 or more | 1.16 Correction factor |
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 0.94 | 1.14 Correction factor |
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 0.95 to 0.96 | 1.12 Correction factor |
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 0.97 to 0.98 | 1.11 Correction factor |
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 0.99 to 1.01 | 1.10 Correction factor |
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 1.02 to 1.04 | 1.09 Correction factor |
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 1.05 to 1.08 | 1.08 Correction factor |
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 1.09 to 1.13 | 1.07 Correction factor |
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 1.14 to 1.19 | 1.06 Correction factor |
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 1.20 to 1.26 | 1.05 Correction factor |
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 1.27 to 1.33 | 1.04 Correction factor |
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 1.34 to 1.40 | 1.03 Correction factor |
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 1.41 to 1.47 | 1.02 Correction factor |
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 1.48 to 1.55 | 1.01 Correction factor |
| Study Participants | Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) | Trough Level Ratio: 1.56 to 1.63 | 1.00 Correction factor |
Secondary
Life Quality Index - 13 Years and Older
For the age group 13 years and older the respondent will be the participant. Each of the four domains has a separate score, each has a different range as follows: Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment.
Time frame: Up to 20 months per subject (throughout entire study)
Population: Safety Analysis Set - participants aged 13 years and older with data (scores) at relevant time points
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Study Participants | Life Quality Index - 13 Years and Older | Treatment Interference | 34.0 Score on a scale |
| Study Participants | Life Quality Index - 13 Years and Older | Therapy-related Problems | 23.0 Score on a scale |
| Study Participants | Life Quality Index - 13 Years and Older | Therapy Settings | 18.0 Score on a scale |
| Study Participants | Life Quality Index - 13 Years and Older | Costs | 8.0 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Life Quality Index - 13 Years and Older | Therapy Settings | 17.0 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Life Quality Index - 13 Years and Older | Therapy-related Problems | 22.5 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Life Quality Index - 13 Years and Older | Treatment Interference | 34.5 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Life Quality Index - 13 Years and Older | Costs | 10.0 Score on a scale |
| SC 20% 145% IV 1 Week | Life Quality Index - 13 Years and Older | Costs | 11.5 Score on a scale |
| SC 20% 145% IV 1 Week | Life Quality Index - 13 Years and Older | Therapy Settings | 20.0 Score on a scale |
| SC 20% 145% IV 1 Week | Life Quality Index - 13 Years and Older | Therapy-related Problems | 24.0 Score on a scale |
| SC 20% 145% IV 1 Week | Life Quality Index - 13 Years and Older | Treatment Interference | 37.0 Score on a scale |
| SC 20% Adjusted 1 Week | Life Quality Index - 13 Years and Older | Treatment Interference | 38.5 Score on a scale |
| SC 20% Adjusted 1 Week | Life Quality Index - 13 Years and Older | Costs | 13.0 Score on a scale |
| SC 20% Adjusted 1 Week | Life Quality Index - 13 Years and Older | Therapy-related Problems | 24.0 Score on a scale |
| SC 20% Adjusted 1 Week | Life Quality Index - 13 Years and Older | Therapy Settings | 20.0 Score on a scale |
| SC 20% Individualized 1 Week | Life Quality Index - 13 Years and Older | Therapy Settings | 1.0 Score on a scale |
| SC 20% Individualized 1 Week | Life Quality Index - 13 Years and Older | Costs | 1.0 Score on a scale |
| SC 20% Individualized 1 Week | Life Quality Index - 13 Years and Older | Therapy-related Problems | 0.0 Score on a scale |
| SC 20% Individualized 1 Week | Life Quality Index - 13 Years and Older | Treatment Interference | 1.0 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Life Quality Index - 13 Years and Older | Therapy-related Problems | 1.0 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Life Quality Index - 13 Years and Older | Therapy Settings | 2.0 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Life Quality Index - 13 Years and Older | Costs | 1.5 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Life Quality Index - 13 Years and Older | Treatment Interference | 3.0 Score on a scale |
Secondary
Life Quality Index - 2 to 12 Years Old
For the age group 2 to 12 years the respondent will be a parent. Each of the four domains has a separate score, each has a different range as follows: Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment.
Time frame: Up to 20 months (throughout entire study)
Population: Safety Analysis Set - participants aged 2-12 years old with data (scores) at relevant time points
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Study Participants | Life Quality Index - 2 to 12 Years Old | Treatment Interference | 32.0 Score on a scale |
| Study Participants | Life Quality Index - 2 to 12 Years Old | Therapy-related Problems | 23.0 Score on a scale |
| Study Participants | Life Quality Index - 2 to 12 Years Old | Therapy Settings | 18.0 Score on a scale |
| Study Participants | Life Quality Index - 2 to 12 Years Old | Costs | 9.0 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Life Quality Index - 2 to 12 Years Old | Therapy Settings | 18.0 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Life Quality Index - 2 to 12 Years Old | Therapy-related Problems | 23.0 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Life Quality Index - 2 to 12 Years Old | Treatment Interference | 31.0 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Life Quality Index - 2 to 12 Years Old | Costs | 11.0 Score on a scale |
| SC 20% 145% IV 1 Week | Life Quality Index - 2 to 12 Years Old | Costs | 11.0 Score on a scale |
| SC 20% 145% IV 1 Week | Life Quality Index - 2 to 12 Years Old | Therapy Settings | 19.0 Score on a scale |
| SC 20% 145% IV 1 Week | Life Quality Index - 2 to 12 Years Old | Therapy-related Problems | 22.0 Score on a scale |
| SC 20% 145% IV 1 Week | Life Quality Index - 2 to 12 Years Old | Treatment Interference | 35.0 Score on a scale |
| SC 20% Adjusted 1 Week | Life Quality Index - 2 to 12 Years Old | Treatment Interference | 34.5 Score on a scale |
| SC 20% Adjusted 1 Week | Life Quality Index - 2 to 12 Years Old | Costs | 10.5 Score on a scale |
| SC 20% Adjusted 1 Week | Life Quality Index - 2 to 12 Years Old | Therapy-related Problems | 21.5 Score on a scale |
| SC 20% Adjusted 1 Week | Life Quality Index - 2 to 12 Years Old | Therapy Settings | 20.0 Score on a scale |
| SC 20% Individualized 1 Week | Life Quality Index - 2 to 12 Years Old | Therapy Settings | 0.0 Score on a scale |
| SC 20% Individualized 1 Week | Life Quality Index - 2 to 12 Years Old | Costs | 1.0 Score on a scale |
| SC 20% Individualized 1 Week | Life Quality Index - 2 to 12 Years Old | Therapy-related Problems | 0.0 Score on a scale |
| SC 20% Individualized 1 Week | Life Quality Index - 2 to 12 Years Old | Treatment Interference | 0.0 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Life Quality Index - 2 to 12 Years Old | Therapy-related Problems | -1.0 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Life Quality Index - 2 to 12 Years Old | Therapy Settings | 1.0 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Life Quality Index - 2 to 12 Years Old | Costs | -0.5 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Life Quality Index - 2 to 12 Years Old | Treatment Interference | -0.5 Score on a scale |
Secondary
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion
Number of AEs that begin during or within 1 hour of completion of infusion divided by number of infusions
Time frame: Within 1 hour of completion of infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion | Non-SAEs - Including infections | 0.157 Adverse events per infusion |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion | SAEs - Including infections | 0 Adverse events per infusion |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion | Non-SAEs - Excluding infections | 0.157 Adverse events per infusion |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion | SAEs - Excluding infections | 0 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion | Non-SAEs - Excluding infections | 0.031 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion | Non-SAEs - Including infections | 0.032 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion | SAEs - Excluding infections | 0 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion | SAEs - Including infections | 0 Adverse events per infusion |
Secondary
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant
Number of AEs that begin during or within 1 hour of completion of infusion divided by number of participants
Time frame: Within 1 hour of completion of infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant | Non-SAEs - Including infections | 0.662 Adverse events per participant |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant | Non-SAEs - Excluding infections | 0.662 Adverse events per participant |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant | SAEs - Including infections | 0 Adverse events per participant |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant | SAEs - Excluding infections | 0 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant | SAEs - Excluding infections | 0 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant | Non-SAEs - Including infections | 1.865 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant | SAEs - Including infections | 0 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant | Non-SAEs - Excluding infections | 1.797 Adverse events per participant |
Secondary
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion
Number of AEs that begin during or within 24 hours of completion of infusion divided by number of infusions
Time frame: Within 24 hours of completion of infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion | Non-SAEs - Including infections | 0.228 Adverse events per infusion |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion | Non-SAEs - Excluding infections | 0.225 Adverse events per infusion |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion | SAEs - Including infections | 0 Adverse events per infusion |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion | SAEs - Excluding infections | 0 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion | SAEs - Excluding infections | 0 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion | Non-SAEs - Including infections | 0.058 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion | SAEs - Including infections | 0 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion | Non-SAEs - Excluding infections | 0.052 Adverse events per infusion |
Secondary
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant
Number of AEs that begin during or within 24 hours of completion of infusion divided by number of participants
Time frame: Within 24 hours of completion of infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant | Non-SAEs - Including infections | 0.961 Adverse events per participant |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant | Non-SAEs - Excluding infections | 0.948 Adverse events per participant |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant | SAEs - Including infections | 0 Adverse events per participant |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant | SAEs - Excluding infections | 0 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant | SAEs - Excluding infections | 0 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant | Non-SAEs - Including infections | 3.365 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant | SAEs - Including infections | 0 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant | Non-SAEs - Excluding infections | 3.027 Adverse events per participant |
Secondary
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion
Number of AEs that begin during or within 72 hours of completion of infusion divided by the number of infusions
Time frame: Within 72 hours of completion of infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion | Non-SAEs - Including infections | 0.327 Adverse events per infusion |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion | Non-SAEs - Excluding infections | 0.299 Adverse events per infusion |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion | SAEs - Including infections | 0.003 Adverse events per infusion |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion | SAEs - Excluding infections | 0.003 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion | SAEs - Excluding infections | 0 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion | Non-SAEs - Including infections | 0.078 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion | SAEs - Including infections | 0 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion | Non-SAEs - Excluding infections | 0.063 Adverse events per infusion |
Secondary
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant
Number of AEs that begin during or within 72 hours of completion of infusion divided by number of participants
Time frame: Within 72 hours of completion of infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant | Non-SAEs - Including infections | 1.377 Adverse events per participant |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant | Non-SAEs - Excluding infections | 1.260 Adverse events per participant |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant | SAEs - Including infections | 0.013 Adverse events per participant |
| Study Participants | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant | SAEs - Excluding infections | 0.013 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant | SAEs - Excluding infections | 0 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant | Non-SAEs - Including infections | 4.581 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant | SAEs - Including infections | 0 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant | Non-SAEs - Excluding infections | 3.703 Adverse events per participant |
Secondary
Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs
Time frame: Up to 20 months (throughout entire study)
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs | Infusion rate reduced | 4 Infusions |
| Study Participants | Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs | Infusion interrupted | 5 Infusions |
| Study Participants | Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs | Infusion stopped | 0 Infusions |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs | Infusion rate reduced | 5 Infusions |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs | Infusion interrupted | 2 Infusions |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs | Infusion stopped | 1 Infusions |
Secondary
Number of Participants With Laboratory Confirmed Hemolysis That Occurred Following Investigational Product Administration
Laboratory tests for confirmation of potential hemolysis include Coomb's test, haptoglobin, free hemoglobin, reticulocyte count, lactate dehydrogenase (LDH), and urine hemosiderin.
Time frame: Epoch 1: 3 week IV interval- weeks 0, 10. Epoch 1: 4 week IV interval- weeks 0, 9. Epoch 3: Subcutaneous (SC) week 9. Epoch 4: SC weeks 17, 18, 40
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Number of Participants With Laboratory Confirmed Hemolysis That Occurred Following Investigational Product Administration | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Participants With Laboratory Confirmed Hemolysis That Occurred Following Investigational Product Administration | 0 Participants |
Secondary
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion
Number of related SAEs and AEs divided by number of subjects and divided by number of infusions
Time frame: Up to 20 months per subject (throughout entire study)
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion | Non-SAEs - Including Infections | 0.247 Adverse events per infusion |
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion | Non-SAEs -Excluding Infections | 0.247 Adverse events per infusion |
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion | SAEs - Including Infections | 0.003 Adverse events per infusion |
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion | SAEs -Excluding Infections | 0.003 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion | SAEs -Excluding Infections | 0 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion | Non-SAEs - Including Infections | 0.036 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion | SAEs - Including Infections | 0 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion | Non-SAEs -Excluding Infections | 0.036 Adverse events per infusion |
Secondary
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant
Number of related SAEs and AEs divided by number of participants
Time frame: Up to 20 months per subject (throughout entire study)
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant | Non-SAEs - Including infections | 1.039 Adverse events per participant |
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant | Non-SAEs - Excluding infections | 1.039 Adverse events per participant |
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant | SAEs - Including infections | 0.013 Adverse events per participant |
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant | SAEs - Excluding infections | 0.013 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant | SAEs - Excluding infections | 0 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant | Non-SAEs - Including infections | 2.122 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant | SAEs - Including infections | 0 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant | Non-SAEs - Excluding infections | 2.122 Adverse events per participant |
Secondary
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion
Number of all SAEs and AEs divided by number of infusions
Time frame: Up to 20 months per subject (throughout entire study)
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion | Non-SAEs - Including infections | 0.390 Adverse events per infusion |
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion | Non-SAEs - Excluding infections | 0.296 Adverse events per infusion |
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion | SAEs - including infections | 0.003 Adverse events per infusion |
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion | SAEs - Excluding infections | 0.003 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion | SAEs - Excluding infections | 0.000 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion | Non-SAEs - Including infections | 0.114 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion | SAEs - including infections | 0.000 Adverse events per infusion |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion | Non-SAEs - Excluding infections | 0.079 Adverse events per infusion |
Secondary
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant
Number of all SAEs and AEs divided by number of participants
Time frame: Up to 20 months per subject (throughout entire study)
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant | Non-SAEs - Including infections | 3.325 Adverse events per participant |
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant | Non-SAEs - Excluding infections | 2.338 Adverse events per participant |
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant | SAEs - Including infections | 0.013 Adverse events per participant |
| Study Participants | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant | SAEs - Excluding infections | 0.013 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant | SAEs - Excluding infections | 0.014 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant | Non-SAEs - Including infections | 9.014 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant | SAEs - Including infections | 0.027 Adverse events per participant |
| Subcutaneous 20% - Epochs 2 Thru 4 | Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant | Non-SAEs - Excluding infections | 6.297 Adverse events per participant |
Secondary
Percentage of Infusions Associated With One or More Local Non-serious Adverse Events (Non-SAEs)
The number of infusions associated with local non-SAEs divided by the total number of infusions.
Time frame: Up to 20 months (throughout entire study)
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Percentage of Infusions Associated With One or More Local Non-serious Adverse Events (Non-SAEs) | 0.9 Percent of infusions |
| Subcutaneous 20% - Epochs 2 Thru 4 | Percentage of Infusions Associated With One or More Local Non-serious Adverse Events (Non-SAEs) | 1.8 Percent of infusions |
Secondary
Percentage of Infusions Tolerated With Intravenous or Subcutaneous Administration
An infusion will be deemed as tolerated unless one of the following occurs: 1. Any serious related AE(s) 2. Any non-serious local or systemic related AE(s) that prevent(s) completion of infusion 3. Any severe non-serious local or systemic related AE(s) that occur within 60 minutes of completion of the infusion
Time frame: Up to 20 months (throughout entire study)
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Percentage of Infusions Tolerated With Intravenous or Subcutaneous Administration | 100 Percent of infusions |
| Subcutaneous 20% - Epochs 2 Thru 4 | Percentage of Infusions Tolerated With Intravenous or Subcutaneous Administration | 100 Percent of infusions |
Secondary
Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs
Time frame: Up to 20 months (throughout entire study)
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs | Infusion rate reduced | 1.3 Percent of participants |
| Study Participants | Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs | Infusion interrupted | 6.5 Percent of participants |
| Study Participants | Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs | Infusion stopped | 0.0 Percent of participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs | Infusion rate reduced | 5.4 Percent of participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs | Infusion interrupted | 1.4 Percent of participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs | Infusion stopped | 1.4 Percent of participants |
Secondary
Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs)
Time frame: Up to 20 months (throughout entire study)
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs) | 3.9 Percent of participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs) | 31.1 Percent of participants |
Secondary
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC)
The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week )
Time frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Study Participants | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC) | 80.79 mg*days/L |
| Subcutaneous 20% - Epochs 2 Thru 4 | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC) | 123.05 mg*days/L |
| SC 20% 145% IV 1 Week | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC) | 29.51 mg*days/L |
| SC 20% Adjusted 1 Week | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC) | 30.64 mg*days/L |
Secondary
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously
Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0- τ). (F= bioavailability)
Time frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Study Participants | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously | 7.18 mL/kg/days |
| Subcutaneous 20% - Epochs 2 Thru 4 | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously | 4.17 mL/kg/days |
| SC 20% 145% IV 1 Week | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously | 7.77 mL/kg/days |
| SC 20% Adjusted 1 Week | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously | 7.05 mL/kg/days |
Secondary
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC)
The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.
Time frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Study Participants | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC) | 139.29 (mg*days/L)/(g/kg) |
| Subcutaneous 20% - Epochs 2 Thru 4 | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC) | 239.99 (mg*days/L)/(g/kg) |
| SC 20% 145% IV 1 Week | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC) | 128.72 (mg*days/L)/(g/kg) |
| SC 20% Adjusted 1 Week | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC) | 141.78 (mg*days/L)/(g/kg) |
Secondary
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax)
The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).
Time frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Study Participants | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax) | 6.31 mg/L |
| Subcutaneous 20% - Epochs 2 Thru 4 | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax) | 7.22 mg/L |
| SC 20% 145% IV 1 Week | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax) | 4.40 mg/L |
| SC 20% Adjusted 1 Week | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax) | 4.86 mg/L |
Secondary
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin)
The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).
Time frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study Participants | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin) | 2.82 mg/L |
| Subcutaneous 20% - Epochs 2 Thru 4 | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin) | 3.13 mg/L |
| SC 20% 145% IV 1 Week | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin) | 3.97 mg/L |
| SC 20% Adjusted 1 Week | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin) | 3.71 mg/L |
Secondary
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax)
The minimum time (Tmax) to reach the maximum concentration (Cmax)
Time frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Study Participants | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax) | 3.11 Hours (s) |
| Subcutaneous 20% - Epochs 2 Thru 4 | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax) | 3.71 Hours (s) |
| SC 20% 145% IV 1 Week | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax) | 70.67 Hours (s) |
| SC 20% Adjusted 1 Week | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax) | 66.87 Hours (s) |
Secondary
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC)
The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week)
Time frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Study Participants | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC) | 352.05 g*days/L |
| Subcutaneous 20% - Epochs 2 Thru 4 | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC) | 410.40 g*days/L |
| SC 20% 145% IV 1 Week | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC) | 108.33 g*days/L |
| SC 20% Adjusted 1 Week | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC) | 115.21 g*days/L |
Secondary
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC)
Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0-τ). (F= bioavailability)
Time frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Population: Safety Analysis Set - sub-groups with data at relevant time point
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Study Participants | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC) | 1.65 mL/kg/days |
| Subcutaneous 20% - Epochs 2 Thru 4 | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC) | 1.26 mL/kg/days |
| SC 20% 145% IV 1 Week | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC) | 2.12 mL/kg/days |
| SC 20% Adjusted 1 Week | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC) | 1.87 mL/kg/days |
Secondary
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC)
The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.
Time frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Study Participants | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC) | 606.99 (g*days/L)/(g/kg) |
| Subcutaneous 20% - Epochs 2 Thru 4 | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC) | 796.30 (g*days/L)/(g/kg) |
| SC 20% 145% IV 1 Week | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC) | 472.50 (g*days/L)/(g/kg) |
| SC 20% Adjusted 1 Week | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC) | 536.05 (g*days/L)/(g/kg) |
Secondary
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax)
The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).
Time frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Study Participants | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax) | 27.09 g/L |
| Subcutaneous 20% - Epochs 2 Thru 4 | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax) | 24.85 g/L |
| SC 20% 145% IV 1 Week | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax) | 17.31 g/L |
| SC 20% Adjusted 1 Week | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax) | 19.31 g/L |
Secondary
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin)
The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).
Time frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Study Participants | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin) | 12.03 g/L |
| Subcutaneous 20% - Epochs 2 Thru 4 | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin) | 10.37 g/L |
| SC 20% 145% IV 1 Week | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin) | 13.85 g/L |
| SC 20% Adjusted 1 Week | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin) | 14.00 g/L |
Secondary
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax)
The minimum time (Tmax) to reach the maximum concentration (Cmax)
Time frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Study Participants | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax) | 6.94 hours (h) |
| Subcutaneous 20% - Epochs 2 Thru 4 | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax) | 5.84 hours (h) |
| SC 20% 145% IV 1 Week | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax) | 54.19 hours (h) |
| SC 20% Adjusted 1 Week | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax) | 78.68 hours (h) |
Secondary
Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years
The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.
Time frame: Up to 20 months (throughout entire study)
Population: Safety Analysis Set (subset of participants aged 2 to 7 years)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Study Participants | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Physical Functioning | 95.31 Score on a scale |
| Study Participants | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Psychosocial Health Summary | 91.67 Score on a scale |
| Study Participants | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Emotional Functioning | 95.00 Score on a scale |
| Study Participants | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Total Score | 92.93 Score on a scale |
| Study Participants | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Social Functioning | 95.00 Score on a scale |
| Study Participants | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Physical Health Summary | 95.31 Score on a scale |
| Study Participants | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | School Functioning | 85.00 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Emotional Functioning | 85.00 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | School Functioning | 75.00 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Social Functioning | 95.00 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Psychosocial Health Summary | 83.33 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Physical Functioning | 93.75 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Total Score | 86.96 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Physical Health Summary | 93.75 Score on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Social Functioning | 97.50 Score on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Emotional Functioning | 82.50 Score on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Physical Functioning | 96.88 Score on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Psychosocial Health Summary | 84.17 Score on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Physical Health Summary | 96.88 Score on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | School Functioning | 81.67 Score on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Total Score | 88.04 Score on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | School Functioning | 67.50 Score on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Physical Functioning | 92.19 Score on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Emotional Functioning | 77.50 Score on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Social Functioning | 87.50 Score on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Psychosocial Health Summary | 77.50 Score on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Physical Health Summary | 92.19 Score on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Total Score | 82.61 Score on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Social Functioning | 0.00 Score on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Emotional Functioning | 0.00 Score on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Total Score | 1.63 Score on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Physical Functioning | 1.56 Score on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Physical Health Summary | 1.56 Score on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | School Functioning | 7.50 Score on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Psychosocial Health Summary | 2.50 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Total Score | 0.00 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Psychosocial Health Summary | -3.33 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Social Functioning | 0.00 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Emotional Functioning | -2.50 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Physical Health Summary | 1.56 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | Physical Functioning | 1.56 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years | School Functioning | -5.00 Score on a scale |
Secondary
Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age
The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.
Time frame: Up to 20 months (throughout entire study)
Population: Safety Analysis Set participants aged 8 to 13 with scores at each respective time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Study Participants | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Physical Functioning | 89.06 Score on a scale |
| Study Participants | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Psychosocial Health Summary | 80.83 Score on a scale |
| Study Participants | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Emotional Functioning | 87.50 Score on a scale |
| Study Participants | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Total Score | 86.41 Score on a scale |
| Study Participants | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Social Functioning | 87.50 Score on a scale |
| Study Participants | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Physical Health Summary | 89.06 Score on a scale |
| Study Participants | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | School Functioning | 75.00 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Emotional Functioning | 80.00 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | School Functioning | 80.00 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Social Functioning | 95.00 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Psychosocial Health Summary | 83.33 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Physical Functioning | 90.63 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Total Score | 89.13 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Physical Health Summary | 90.63 Score on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Social Functioning | 95.00 Score on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Emotional Functioning | 80.00 Score on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Physical Functioning | 87.50 Score on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Psychosocial Health Summary | 81.67 Score on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Physical Health Summary | 87.50 Score on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | School Functioning | 75.00 Score on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Total Score | 81.52 Score on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | School Functioning | 70.00 Score on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Physical Functioning | 93.75 Score on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Emotional Functioning | 87.50 Score on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Social Functioning | 95.00 Score on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Psychosocial Health Summary | 81.67 Score on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Physical Health Summary | 93.75 Score on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Total Score | 85.87 Score on a scale |
| SC 20% Individualized 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Social Functioning | 0.00 Score on a scale |
| SC 20% Individualized 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Emotional Functioning | 0.00 Score on a scale |
| SC 20% Individualized 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Total Score | 1.09 Score on a scale |
| SC 20% Individualized 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Physical Functioning | 0.00 Score on a scale |
| SC 20% Individualized 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Physical Health Summary | 0.00 Score on a scale |
| SC 20% Individualized 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | School Functioning | 0.00 Score on a scale |
| SC 20% Individualized 1 Week | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Psychosocial Health Summary | 0.00 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Total Score | 2.17 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Psychosocial Health Summary | 3.33 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Social Functioning | 0.00 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Emotional Functioning | 10.00 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Physical Health Summary | 6.25 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | Physical Functioning | 6.25 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age | School Functioning | -2.50 Score on a scale |
Secondary
Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older
The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both sub-scores and summary scores.
Time frame: Up to 20 months (throughout entire study)
Population: Safety Analysis Set participants aged 14 years and older with scores at each respective time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Study Participants | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Vitality | 42.72 Scores on a scale |
| Study Participants | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | General Health | 38.63 Scores on a scale |
| Study Participants | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Bodily Pain | 43.95 Scores on a scale |
| Study Participants | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Mental Component Summary | 49.92 Scores on a scale |
| Study Participants | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Physical Component Summary | 41.57 Scores on a scale |
| Study Participants | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Mental Health | 50.01 Scores on a scale |
| Study Participants | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Role-Emotional | 51.99 Scores on a scale |
| Study Participants | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Role-Physical | 44.61 Scores on a scale |
| Study Participants | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Physical Functioning | 48.61 Scores on a scale |
| Study Participants | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Social Functioning | 45.94 Scores on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Bodily Pain | 45.64 Scores on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Physical Functioning | 52.82 Scores on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Role-Physical | 42.16 Scores on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Vitality | 42.72 Scores on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | General Health | 41.02 Scores on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Social Functioning | 45.94 Scores on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Role-Emotional | 55.88 Scores on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Mental Health | 52.82 Scores on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Physical Component Summary | 39.93 Scores on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Mental Component Summary | 49.45 Scores on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Physical Functioning | 50.72 Scores on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Mental Health | 50.01 Scores on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Vitality | 45.85 Scores on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Role-Physical | 49.51 Scores on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Bodily Pain | 50.29 Scores on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Social Functioning | 51.40 Scores on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | General Health | 38.63 Scores on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Physical Component Summary | 46.13 Scores on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Mental Component Summary | 49.70 Scores on a scale |
| SC 20% 145% IV 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Role-Emotional | 51.99 Scores on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Social Functioning | 51.40 Scores on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Physical Functioning | 50.72 Scores on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Role-Physical | 47.06 Scores on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Mental Component Summary | 51.59 Scores on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Role-Emotional | 53.94 Scores on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Mental Health | 52.82 Scores on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Physical Component Summary | 46.07 Scores on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Vitality | 48.97 Scores on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | General Health | 38.63 Scores on a scale |
| SC 20% Adjusted 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Bodily Pain | 46.06 Scores on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Role-Physical | 2.45 Scores on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | General Health | 0.95 Scores on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Vitality | 3.12 Scores on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Social Functioning | 0.00 Scores on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Role-Emotional | 0.00 Scores on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Physical Functioning | 0.00 Scores on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Mental Health | 0.00 Scores on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Mental Component Summary | 0.57 Scores on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Physical Component Summary | 1.22 Scores on a scale |
| SC 20% Individualized 1 Week | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Bodily Pain | 4.23 Scores on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Physical Functioning | 0.00 Scores on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Social Functioning | 0.00 Scores on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Bodily Pain | 0.00 Scores on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Role-Physical | 2.45 Scores on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Physical Component Summary | 0.89 Scores on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Mental Component Summary | 1.31 Scores on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Vitality | 1.56 Scores on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Mental Health | 1.41 Scores on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | Role-Emotional | 0.00 Scores on a scale |
| Change End Epoch 1 to End Epoch 4 | Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older | General Health | 0.72 Scores on a scale |
Secondary
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 77 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 73 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 1 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 72 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 2 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 45 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 41 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 36 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 1 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 69 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 2 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 2 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 1 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 67 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 3 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 69 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 1 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 1 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 41 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 2 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 37 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 1 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
Secondary
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 35 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 61 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 8 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 3 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 1 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 53 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 9 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 4 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 3 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 55 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 9 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 2 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 40 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 1 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 36 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 2 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 32 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 1 Participants |
| Study Participants | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 2 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 32 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 7 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 28 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 5 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 2 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 35 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 11 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 19 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 2 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 2 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 2 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 32 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 6 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 26 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 4 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 2 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 1 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 1 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 18 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 9 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 17 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 18 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 4 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 18 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 5 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 13 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 6 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 11 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 10 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 1 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 61 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
Secondary
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 2 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 62 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 5 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 59 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 9 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 2 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 38 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 1 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 2 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 1 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 35 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 2 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 2 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 1 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 32 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 2 Participants |
| Study Participants | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 1 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| Subcutaneous 20% - Epochs 2 Thru 4 | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% 145% IV 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 1 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Adjusted 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 2 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 3 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 0 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 4 | 0 Participants |
| SC 20% Individualized 1 Week | Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 | Maximum Post-Infusion Grade 1 | 0 Participants |
Secondary
Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older
TSQM; for the age group 13 years and older the observer will be the participant. Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.
Time frame: Up to 20 months per subject (throughout entire study)
Population: Safety Analysis Set - participants aged 13 years and older with data (scores) at relevant time points
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Study Participants | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Convenience | 66.67 Score on a scale |
| Study Participants | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Effectiveness | 77.78 Score on a scale |
| Study Participants | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Global Satisfaction | 85.71 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Convenience | 66.67 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Effectiveness | 80.56 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Global Satisfaction | 85.71 Score on a scale |
| SC 20% 145% IV 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Convenience | 83.33 Score on a scale |
| SC 20% 145% IV 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Effectiveness | 83.33 Score on a scale |
| SC 20% 145% IV 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Global Satisfaction | 92.86 Score on a scale |
| SC 20% Adjusted 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Convenience | 83.33 Score on a scale |
| SC 20% Adjusted 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Effectiveness | 83.33 Score on a scale |
| SC 20% Adjusted 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Global Satisfaction | 92.86 Score on a scale |
| SC 20% Individualized 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Convenience | 11.11 Score on a scale |
| SC 20% Individualized 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Effectiveness | 0.00 Score on a scale |
| SC 20% Individualized 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Global Satisfaction | 0.00 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Effectiveness | 0.00 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Global Satisfaction | 0.00 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older | Convenience | 11.11 Score on a scale |
Secondary
Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old
TSQM; for the age group 2 to 12 years the observer will be a parent. Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.
Time frame: Up to 20 months per subject (throughout entire study)
Population: Safety Analysis Set - participants aged 2-12 years old with data (scores) at relevant time points
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Study Participants | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Convenience | 75.00 Score on a scale |
| Study Participants | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Effectiveness | 83.33 Score on a scale |
| Study Participants | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Global Satisfaction | 85.71 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Convenience | 72.22 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Effectiveness | 88.89 Score on a scale |
| Subcutaneous 20% - Epochs 2 Thru 4 | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Global Satisfaction | 92.86 Score on a scale |
| SC 20% 145% IV 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Convenience | 80.56 Score on a scale |
| SC 20% 145% IV 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Effectiveness | 83.33 Score on a scale |
| SC 20% 145% IV 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Global Satisfaction | 100.00 Score on a scale |
| SC 20% Adjusted 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Convenience | 77.78 Score on a scale |
| SC 20% Adjusted 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Effectiveness | 91.67 Score on a scale |
| SC 20% Adjusted 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Global Satisfaction | 89.29 Score on a scale |
| SC 20% Individualized 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Convenience | 5.56 Score on a scale |
| SC 20% Individualized 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Effectiveness | 0.00 Score on a scale |
| SC 20% Individualized 1 Week | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Global Satisfaction | 0.00 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Effectiveness | 0.00 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Global Satisfaction | 0.00 Score on a scale |
| Change End Epoch 1 to End Epoch 4 | Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old | Convenience | 5.56 Score on a scale |
Secondary
Trough Levels of Anti-Haemophilus Influenza B Antibody
Time frame: Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | Pre-Study Medication- Epoch 1 Week 1 (N= 65) | 2.91 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | IV 10% 3 Weeks- Epoch 1 Week 4 (N= 15) | 2.71 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | IV 10% 3 Weeks- Epoch 1 Week 7 (N= 16) | 3.08 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | IV 10% 3 Weeks- Epoch 1 Week 10 (N= 19) | 2.42 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | IV 10% 3 Weeks- Epoch 1 Week 13 (N= 14) | 2.47 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | IV 10% 4 Weeks- Epoch 1 Week 5 (N= 45) | 2.82 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | IV 10% 4 Weeks- Epoch 1 Week 9 (N= 44) | 2.71 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | IV 10% 4 Weeks- Epoch 1 Week 13 (N= 43) | 2.74 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | SC 20% 145% IV 1 Week- Epoch 2 Week 5 (N= 29) | 4.07 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | SC 20% 145% IV 1 Week- Epoch 2 Week 9 (N= 27) | 3.94 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | SC 20% adjusted 1 Week- Epoch 3 Week 5 (N= 56) | 3.59 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | SC 20% adjusted 1 Week- Epoch 3 Week 9 (N= 58) | 3.62 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | SC 20% adjusted 1 Week- Epoch 4 Week 1 (N= 62) | 3.47 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | SC 20% individualized 1 Week Epoch 4 Week 9 (N=58) | 4.35 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | SC 20% individualized 1 Week Epoch 4 Week 17(N=51) | 4.76 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | SC 20% individualized 1 Week Epoch 4 Week 29(N=54) | 4.06 mg/L |
| Study Participants | Trough Levels of Anti-Haemophilus Influenza B Antibody | SC 20% individualized 1 Week- End of Study (N= 52) | 5.07 mg/L |
Secondary
Trough Levels of Anti-Hepatitis B Antibody
Time frame: Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | Pre-Study Medication- Epoch 1 Week 1 (N= 66) | 266.6 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | IV 10% 3 Weeks- Epoch 1 Week 4 (N= 15) | 357.8 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | IV 10% 3 Weeks- Epoch 1 Week 7 (N= 17) | 402.6 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | IV 10% 3 Weeks- Epoch 1 Week 10 (N= 19) | 376.6 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | IV 10% 3 Weeks- Epoch 1 Week 13 (N= 16) | 392.2 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | IV 10% 4 Weeks- Epoch 1 Week 5 (N= 45) | 301.1 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | IV 10% 4 Weeks- Epoch 1 Week 9 (N= 44) | 304.0 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | IV 10% 4 Weeks- Epoch 1 Week 13 (N= 43) | 296.3 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | SC 20% 145% IV 1 Week- Epoch 2 Week 5 (N= 29) | 463.7 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | SC 20% 145% IV 1 Week- Epoch 2 Week 9 (N= 27) | 525.0 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | SC 20% adjusted 1 Week- Epoch 3 Week 5 (N= 57) | 581.9 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | SC 20% adjusted 1 Week- Epoch 3 Week 9 (N= 58) | 622.4 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | SC 20% adjusted 1 Week- Epoch 4 Week 1 (N= 62) | 552.8 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | SC 20% individualized 1 Week Epoch 4 Week 9(N= 58) | 434.4 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | SC 20% individualized 1 Week Epoch 4 Week 17(N=53) | 444.5 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | SC 20% individualized 1 Week Epoch 4 Week 29(N=54) | 389.2 mIU/mL |
| Study Participants | Trough Levels of Anti-Hepatitis B Antibody | SC 20% individualized 1 Week- End of Study (N=56) | 403.1 mIU/mL |
Secondary
Trough Levels of Anti-Tetanus Antibody
Time frame: Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Participants | Trough Levels of Anti-Tetanus Antibody | Pre-Study Medication- Epoch 1 Week 1 (N= 64) | 2.28 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | IV 10% 3 Weeks- Epoch 1 Week 4 (N= 15) | 3.36 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | IV 10% 3 Weeks- Epoch 1 Week 7 (N= 16) | 2.66 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | IV 10% 3 Weeks - Epoch 1 Week 10 (N= 19) | 2.55 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | IV 10% 3 Weeks- Epoch 1 Week 13 (N= 16) | 2.26 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | IV 10% 4 Weeks- Epoch 1 Week 5 (N= 46) | 1.92 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | IV 10% 4 Weeks- Epoch 1 Week 9 (N= 44) | 2.31 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | IV 10% 4 Weeks- Epoch 1 Week 13 (N= 43) | 2.28 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | SC 20% 145% IV 1 Week- Epoch 2 Week 5 (N= 29) | 4.08 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | SC 20% 145% IV 1 Week- Epoch 2 Week 9 (N= 27) | 4.49 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | SC 20% adjusted 1 Week- Epoch 3 Week 5 (N= 55) | 3.76 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | SC 20% adjusted 1 Week- Epoch 3 Week 9 (N= 58) | 3.09 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | SC 20% adjusted 1 Week- Epoch 4 Week 1 (N= 62) | 2.75 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | SC 20% individualized 1 Week Epoch 4 Week 9 (N=58) | 3.15 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | SC 20% individualized 1 Week Epoch 4 Week 17(N=51) | 3.17 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | SC 20% individualized 1 Week Epoch 4 Week 29(N=54) | 1.74 IU/mL |
| Study Participants | Trough Levels of Anti-Tetanus Antibody | SC 20% individualized 1 Week- End of Study (N= 53) | 1.97 IU/mL |
Secondary
Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals
Time frame: Epoch 1: 3 week IV interval- weeks 0, 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 0, 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)
Population: Safety Analysis Set - sub-groups with data at relevant time points
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Participants | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 3 | 0.352 g/L |
| Study Participants | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | Total IgG | 11.58 g/L |
| Study Participants | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 4 | 0.239 g/L |
| Study Participants | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 1 | 6.23 g/L |
| Study Participants | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 2 | 3.92 g/L |
| Subcutaneous 20% - Epochs 2 Thru 4 | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 3 | 0.405 g/L |
| Subcutaneous 20% - Epochs 2 Thru 4 | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 2 | 3.30 g/L |
| Subcutaneous 20% - Epochs 2 Thru 4 | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 1 | 5.45 g/L |
| Subcutaneous 20% - Epochs 2 Thru 4 | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 4 | 0.186 g/L |
| Subcutaneous 20% - Epochs 2 Thru 4 | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | Total IgG | 10.19 g/L |
| SC 20% 145% IV 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 2 | 4.83 g/L |
| SC 20% 145% IV 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | Total IgG | 14.77 g/L |
| SC 20% 145% IV 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 1 | 8.06 g/L |
| SC 20% 145% IV 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 3 | 0.516 g/L |
| SC 20% 145% IV 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 4 | 0.309 g/L |
| SC 20% Adjusted 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 4 | 0.304 g/L |
| SC 20% Adjusted 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | Total IgG | 14.20 g/L |
| SC 20% Adjusted 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 3 | 0.514 g/L |
| SC 20% Adjusted 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 2 | 4.95 g/L |
| SC 20% Adjusted 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 1 | 7.83 g/L |
| SC 20% Individualized 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 2 | 4.94 g/L |
| SC 20% Individualized 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 3 | 0.514 g/L |
| SC 20% Individualized 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | Total IgG | 14.74 g/L |
| SC 20% Individualized 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 4 | 0.311 g/L |
| SC 20% Individualized 1 Week | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | IgG Subclass 1 | 7.41 g/L |