| 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. | | Posted | | Number | | Estimated infections/ year | | 1 year | | | | ID | Title | Description |
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| OG000 | Study Participants | |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Poisson | | <0.0001 | | Poisson | 0.012 | | | 1-Sided | 99 | | 0.024 | | | | | Superiority or Other (legacy) | | |
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| Secondary | Annual Rate of All Infections Per Participant | | | Posted | | Number | 95% Confidence Interval | Estimated infections/year | | 1 year | | | | ID | Title | Description |
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| OG000 | Intravenous 10% - Epoch 1 | - 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. | | OG001 | Subcutaneous 20% - Epochs 2 Thru 4 | - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. |
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| Secondary | Annual Rate of Sinus Infections Per Participant | | | Posted | | Number | 99% Confidence Interval | Estimated infections/year | | 1 year | | | | ID | Title | Description |
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| OG000 | Intravenous 10% - Epoch 1 | - 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. | | OG001 | Subcutaneous 20% - Epochs 2 Thru 4 | - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. |
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| Secondary | Annual Rate of Fever Episodes Per Participant | | | Posted | | Number | 95% Confidence Interval | Estimated episodes/year | | 1 year | | | | ID | Title | Description |
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| OG000 | Intravenous 10% - Epoch 1 | - 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. | | OG001 | Subcutaneous 20% - Epochs 2 Thru 4 | - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. |
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| Secondary | Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant | | | Posted | | Number | 95% Confidence Interval | Estimated days off/participant | | 1 year | | | | ID | Title | Description |
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| OG000 | Intravenous 10% - Epoch 1 | - 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. | | OG001 | Subcutaneous 20% - Epochs 2 Thru 4 | - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. |
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| Secondary | Annual Rate of Days on Antibiotics Per Participant | | | Posted | | Number | 95% Confidence Interval | Estimated days/particpant | | 1 year | | | | ID | Title | Description |
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| OG000 | Intravenous 10% - Epoch 1 | - 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. | | OG001 | Subcutaneous 20% - Epochs 2 Thru 4 | - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. |
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| Secondary | Annual Rate of Hospitalizations for Illness or Infection Per Participant | | | Posted | | Number | 95% Confidence Interval | Estimated hospitalizations/participant | | 1 year | | | | ID | Title | Description |
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| OG000 | Intravenous 10% - Epoch 1 | - 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. | | OG001 | Subcutaneous 20% - Epochs 2 Thru 4 | - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. |
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| Secondary | Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant | | | Posted | | Number | 95% Confidence Interval | Estimated days/participant | | 1 year | | | | ID | Title | Description |
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| OG000 | Intravenous 10% - Epoch 1 | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | | OG001 | Subcutaneous 20% - Epochs 2 Thru 4 | Epoch 2 (12-16 weeks): PK assessment (in 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 subcutaneously every 7 days at a 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. |
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| Secondary | Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant | | | Posted | | Number | 95% Confidence Interval | Estimated visits/participant | | 1 year | | | | ID | Title | Description |
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| OG000 | Intravenous 10% - Epoch 1 | - 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. | | OG001 | Subcutaneous 20% - Epochs 2 Thru 4 | - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. |
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| 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 | Safety Analysis Set with correctly administered IGIV 10% dose in Epoch 1 | Posted | | Geometric Mean | 90% Confidence Interval | Ratio | | 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 | | | | ID | Title | Description |
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| OG000 | Study Epochs 1-4 | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 2 (12-16 weeks): PK assessment (in 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 subcutaneously every 7 days at a 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. |
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| Secondary | Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals | | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Geometric Mean | 95% Confidence Interval | g/L | | 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) | | | | ID | Title | Description |
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| OG000 | IV 10% 3 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 2 (12-16 weeks): PK assessment (in 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 subcutaneously every 7 days at a 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. | | OG001 | IV 10% 4 Weeks | | | OG002 |
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| Secondary | Trough Levels of Anti-Tetanus Antibody | | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | 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) | | | | ID | Title | Description |
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| OG000 | Overall Study Arm | |
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| Secondary | Trough Levels of Anti-Haemophilus Influenza B Antibody | | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Geometric Mean | 95% Confidence Interval | mg/L | | 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) | | | | ID | Title | Description |
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| OG000 | Overall Study Arm | |
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| Secondary | Trough Levels of Anti-Hepatitis B Antibody | | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | 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) | | | | ID | Title | Description |
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| OG000 | Study Epochs 1-4 | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 2 (12-16 weeks): PK assessment (in 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 subcutaneously every 7 days at a 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. |
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| 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-Ï„ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Geometric Mean | 95% Confidence Interval | g*days/L | | 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 | | | | ID | Title | Description |
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| OG000 | Study Epoch 1: IGIV 10% Every 3 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG001 | Study Epoch 1: IGIV 10% Every 4 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) |
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| 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-Ï„ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight. | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Geometric Mean | 95% Confidence Interval | (g*days/L)/(g/kg) | | 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 | | | | ID | Title | Description |
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| OG000 | Study Epoch 1: IGIV 10% Every 3 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG001 | Study Epoch 1: IGIV 10% Every 4 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) |
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| 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-Ï„). (F= bioavailability) | Safety Analysis Set - sub-groups with data at relevant time point | Posted | | Geometric Mean | 95% Confidence Interval | mL/kg/days | | 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 | | | | ID | Title | Description |
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| OG000 | Study Epoch 1: IGIV 10% Every 3 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG001 | Study Epoch 1: IGIV 10% Every 4 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG002 |
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| 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). | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Geometric Mean | 95% Confidence Interval | g/L | | 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 | | | | ID | Title | Description |
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| OG000 | Study Epoch 1: IGIV 10% Every 3 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG001 | Study Epoch 1: IGIV 10% Every 4 Week | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG002 | Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 % |
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| Secondary | Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax) | The minimum time (Tmax) to reach the maximum concentration (Cmax) | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Geometric Mean | 95% Confidence Interval | hours (h) | | 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 | | | | ID | Title | Description |
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| OG000 | Study Epoch 1: IGIV 10% Every 3 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG001 | Study Epoch 1: IGIV 10% Every 4 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG002 | Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 % | Epoch 2 (12-16 weeks): PK assessment (in 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 subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC) |
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| 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). | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Geometric Mean | 95% Confidence Interval | g/L | | 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 | | | | ID | Title | Description |
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| OG000 | Study Epoch 1: IGIV 10% Every 3 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG001 | Study Epoch 1: IGIV 10% Every 4 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG002 | Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 % |
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| 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-Ï„ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week ) | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Geometric Mean | 95% Confidence Interval | mg*days/L | | 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 | | | | ID | Title | Description |
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| OG000 | Study Epoch 1: IGIV 10% Every 3 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG001 | Study Epoch 1: IGIV 10% Every 4 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) |
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| 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-Ï„ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight. | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Geometric Mean | 95% Confidence Interval | (mg*days/L)/(g/kg) | | 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 | | | | ID | Title | Description |
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| OG000 | Study Epoch 1: IGIV 10% Every 3 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG001 | Study Epoch 1: IGIV 10% Every 4 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) |
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| 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- Ï„). (F= bioavailability) | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Geometric Mean | 95% Confidence Interval | mL/kg/days | | 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 | | | | ID | Title | Description |
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| OG000 | Study Epoch 1: IGIV 10% Every 3 WeeksOverall Study Arm | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG001 | Study Epoch 1: IGIV 10% Every 4 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | |
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| 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). | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Geometric Mean | 95% Confidence Interval | mg/L | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Study Epoch 1: IGIV 10% Every 3 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG001 | Study Epoch 1: IGIV 10% Every 4 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG002 | Study Epoch 2: IGSC 20%, 145% of IGIV 10% |
|
| Secondary | Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax) | The minimum time (Tmax) to reach the maximum concentration (Cmax) | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Geometric Mean | 95% Confidence Interval | Hours (s) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Study Epoch 1: IGIV 10% Every 3 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG001 | Study Epoch 1: IGIV 10% Every 4 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG002 | Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 % | Epoch 2 (12-16 weeks): PK assessment (in 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 subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC) |
|
| 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). | Safety Analysis Set - sub-groups with data at relevant time points | Posted | | Median | 95% Confidence Interval | mg/L | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Study Epoch 1: IGIV 10% Every 3 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG001 | Study Epoch 1: IGIV 10% Every 4 Weeks | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV) | | OG002 | Study Epoch 2: IGSC 20%, 145% of IGIV 10% |
|
| 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. | Pharmacokinetics interim analysis set to determine the Individually Adapted Dose for Epoch 4 | Posted | | Number | | Correction factor | | 29 weeks | | | | ID | Title | Description |
|---|
| OG000 | Correction Factor | |
| |
| 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 | | Posted | | Number | | Adverse events per participant | | Up to 20 months per subject (throughout entire study) | | | | ID | Title | Description |
|---|
| OG000 | INTRAVENOUS 10% | | | OG001 | SUBCUTANEOUS 20% | |
| |
| 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 | | Posted | | Number | | Adverse events per infusion | | Up to 20 months per subject (throughout entire study) | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | INTRAVENOUS 10% | | | OG001 | SUBCUTANEOUS 20% | |
| |
| 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 | | Posted | | Number | | Adverse events per participant | | Up to 20 months per subject (throughout entire study) | | | | ID | Title | Description |
|---|
| OG000 | INTRAVENOUS 10% | | | OG001 | SUBCUTANEOUS 20% | |
| |
| 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 | | Posted | | Number | | Adverse events per infusion | | Up to 20 months per subject (throughout entire study) | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | IGIV, 10% | | | OG001 | Subcutaneous, 20% | |
| |
| 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 | | Posted | | Number | | Adverse events per participant | | Within 72 hours of completion of infusion | | | | ID | Title | Description |
|---|
| OG000 | Intravenous 10% | | | OG001 | Subcutaneous 20% | |
| |
| 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 | | Posted | | Number | | Adverse events per infusion | | Within 72 hours of completion of infusion | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | Intravenous 10% | | | OG001 | Subcutaneous 20% | |
| |
| 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 | | Posted | | Number | | Adverse events per participant | | Within 24 hours of completion of infusion | | | | ID | Title | Description |
|---|
| OG000 | Intravenous 10% | | | OG001 | Subcutaneous 20% | |
| |
| 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 | | Posted | | Number | | Adverse events per infusion | | Within 24 hours of completion of infusion | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | Intravenous 10% | | | OG001 | Subcutaneous 20% | |
| |
| 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 | | Posted | | Number | | Adverse events per participant | | Within 1 hour of completion of infusion | | | | ID | Title | Description |
|---|
| OG000 | Intravenous 10% | | | OG001 | Subcutaneous 20% | |
| |
| 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 | | Posted | | Number | | Adverse events per infusion | | Within 1 hour of completion of infusion | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | Intravenous 10% | | | OG001 | Subcutaneous 20% | |
| |
| 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 | | Posted | | Number | | Adverse events 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 | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | Intravenous 10% | | | OG001 | Subcutaneous 20% | |
| |
| 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. | | Posted | | Number | | Percent of infusions | | Up to 20 months (throughout entire study) | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | Intravenous 10% | | | OG001 | Subcutaneous 20% | |
| |
| Secondary | Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs) | | | Posted | | Number | | Percent of participants | | Up to 20 months (throughout entire study) | | | | ID | Title | Description |
|---|
| OG000 | Intravenous 10% | | | OG001 | Subcutaneous 20% | |
| |
| 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 | | | Posted | | Number | | Infusions | | Up to 20 months (throughout entire study) | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | Intravenous 10% | | | OG001 | Subcutaneous 20% | |
| |
| 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 | | | Posted | | Number | | Percent of participants | | Up to 20 months (throughout entire study) | | | | ID | Title | Description |
|---|
| OG000 | Intravenous 10% | | | OG001 | Subcutaneous 20% | |
| |
| 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 | | Posted | | Number | | Percent of infusions | | Up to 20 months (throughout entire study) | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | Intravenous 10% | | | OG001 | Subcutaneous 20% | |
| |
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Systolic Blood Pressure | | OG001 | Pre-Infusion Toxicity Grade 1 | Systolic Blood Pressure 141-150 mmHg | | OG002 | Pre-Infusion Toxicity Grade 2 | Systolic Blood Pressure 151-155 mmHg |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Systolic Blood Pressure | | OG001 | Pre-Infusion Toxicity Grade 1 | Systolic Blood Pressure 141-150 mmHg | | OG002 | Pre-Infusion Toxicity Grade 2 | Systolic Blood Pressure 151-155 mmHg |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Systolic Blood Pressure | | OG001 | Pre-Infusion Toxicity Grade 1 | Systolic Blood Pressure 141-150 mmHg | | OG002 | Pre-Infusion Toxicity Grade 2 | Systolic Blood Pressure 151-155 mmHg |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Systolic Blood Pressure | | OG001 | Pre-Infusion Toxicity Grade 1 | Systolic Blood Pressure 141-150 mmHg | | OG002 | Pre-Infusion Toxicity Grade 2 | Systolic Blood Pressure 151-155 mmHg |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Systolic Blood Pressure | | OG001 | Pre-Infusion Toxicity Grade 1 | Systolic Blood Pressure 141-150 mmHg | | OG002 | Pre-Infusion Toxicity Grade 2 | Systolic Blood Pressure 151-155 mmHg |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Systolic Blood Pressure | | OG001 | Pre-Infusion Toxicity Grade 1 | Systolic Blood Pressure 141-150 mmHg | | OG002 | Pre-Infusion Toxicity Grade 2 | Systolic Blood Pressure 151-155 mmHg |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Diastolic Blood Pressure | | OG001 | Pre-Infusion Toxicity Grade 1 | Diastolic Blood Pressure 141-150 mmHg | | OG002 | Pre-Infusion Toxicity Grade 2 | Diastolic Blood Pressure 151-155 mmHg |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Diastolic Blood Pressure | | OG001 | Pre-Infusion Toxicity Grade 1 | Diastolic Blood Pressure 141-150 mmHg | | OG002 | Pre-Infusion Toxicity Grade 2 | Diastolic Blood Pressure 151-155 mmHg |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Diastolic Blood Pressure | | OG001 | Pre-Infusion Toxicity Grade 1 | Diastolic Blood Pressure 141-150 mmHg | | OG002 | Pre-Infusion Toxicity Grade 2 | Diastolic Blood Pressure 151-155 mmHg |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Systolic Blood Pressure | | OG001 | Pre-Infusion Toxicity Grade 1 | Systolic Blood Pressure 141-150 mmHg | | OG002 | Pre-Infusion Toxicity Grade 2 | Systolic Blood Pressure 151-155 mmHg |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Systolic Blood Pressure | | OG001 | Pre-Infusion Toxicity Grade 1 | Systolic Blood Pressure 141-150 mmHg | | OG002 | Pre-Infusion Toxicity Grade 2 | Systolic Blood Pressure 151-155 mmHg |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Systolic Blood Pressure | | OG001 | Pre-Infusion Toxicity Grade 1 | Systolic Blood Pressure 141-150 mmHg | | OG002 | Pre-Infusion Toxicity Grade 2 | Systolic Blood Pressure 151-155 mmHg |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Heart Rate (Pulse) | | OG001 | Pre-Infusion Toxicity Grade 1 | Heart Rate (Pulse): Either Bradycardia (50 - 54 beats per minute) OR Tachycardia (101 - 115 beats per minute) | | OG002 | Pre-Infusion Toxicity Grade 2 | |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Heart Rate (Pulse) | | OG001 | Pre-Infusion Toxicity Grade 1 | Heart Rate (Pulse): Either Bradycardia (50 - 54 beats per minute) OR Tachycardia (101 - 115 beats per minute) | | OG002 | Pre-Infusion Toxicity Grade 2 | |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Heart Rate (Pulse) | | OG001 | Pre-Infusion Toxicity Grade 1 | Heart Rate (Pulse): Either Bradycardia (50 - 54 beats per minute) OR Tachycardia (101 - 115 beats per minute) | | OG002 | Pre-Infusion Toxicity Grade 2 | |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Heart Rate (Pulse) | | OG001 | Pre-Infusion Toxicity Grade 1 | Heart Rate (Pulse): Either Bradycardia (50 - 54 beats per minute) OR Tachycardia (101 - 115 beats per minute) | | OG002 | Pre-Infusion Toxicity Grade 2 | |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Heart Rate (Pulse) | | OG001 | Pre-Infusion Toxicity Grade 1 | Heart Rate (Pulse): Either Bradycardia (50 - 54 beats per minute) OR Tachycardia (101 - 115 beats per minute) | | OG002 | Pre-Infusion Toxicity Grade 2 | |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | Normal Heart Rate (Pulse) | | OG001 | Pre-Infusion Toxicity Grade 1 | Heart Rate (Pulse): Either Bradycardia (50 - 54 beats per minute) OR Tachycardia (101 - 115 beats per minute) | | OG002 | Pre-Infusion Toxicity Grade 2 | |
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| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | | | OG001 | Pre-Infusion Toxicity Grade 1 | Respiratory Rate: 17 - 20 breaths per minute | | OG002 | Pre-Infusion Toxicity Grade 2 | Respiratory Rate: 21 - 25 breaths per minute |
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| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | | | OG001 | Pre-Infusion Toxicity Grade 1 | Respiratory Rate: 17 - 20 breaths per minute | | OG002 | Pre-Infusion Toxicity Grade 2 | Respiratory Rate: 21 - 25 breaths per minute |
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| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | | | OG001 | Pre-Infusion Toxicity Grade 1 | Respiratory Rate: 17 - 20 breaths per minute | | OG002 | Pre-Infusion Toxicity Grade 2 | Respiratory Rate: 21 - 25 breaths per minute |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | | | OG001 | Pre-Infusion Toxicity Grade 1 | Respiratory Rate: 17 - 20 breaths per minute | | OG002 | Pre-Infusion Toxicity Grade 2 | Respiratory Rate: 21 - 25 breaths per minute |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | | | OG001 | Pre-Infusion Toxicity Grade 1 | Respiratory Rate: 17 - 20 breaths per minute | | OG002 | Pre-Infusion Toxicity Grade 2 | Respiratory Rate: 21 - 25 breaths per minute |
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| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | | | OG001 | Pre-Infusion Toxicity Grade 1 | Respiratory Rate: 17 - 20 breaths per minute | | OG002 | Pre-Infusion Toxicity Grade 2 | Respiratory Rate: 21 - 25 breaths per minute |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | | | OG001 | Pre-Infusion Toxicity Grade 1 | Body Temperature, Fever (°C) of: 38.0 - 38.4 | | OG002 | Pre-Infusion Toxicity Grade 2 | Body Temperature, Fever (°C) of: 38.5 - 38.9 |
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| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | | | OG001 | Pre-Infusion Toxicity Grade 1 | Body Temperature, Fever (°C) of: 38.0 - 38.4 | | OG002 | Pre-Infusion Toxicity Grade 2 | Body Temperature, Fever (°C) of: 38.5 - 38.9 |
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| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | | | OG001 | Pre-Infusion Toxicity Grade 1 | Body Temperature, Fever (°C) of: 38.0 - 38.4 | | OG002 | Pre-Infusion Toxicity Grade 2 | Body Temperature, Fever (°C) of: 38.5 - 38.9 |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | | | OG001 | Pre-Infusion Toxicity Grade 1 | Body Temperature, Fever (°C) of: 38.0 - 38.4 | | OG002 | Pre-Infusion Toxicity Grade 2 | Body Temperature, Fever (°C) of: 38.5 - 38.9 |
|
| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | | | OG001 | Pre-Infusion Toxicity Grade 1 | Body Temperature, Fever (°C) of: 38.0 - 38.4 | | OG002 | Pre-Infusion Toxicity Grade 2 | Body Temperature, Fever (°C) of: 38.5 - 38.9 |
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| 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. | | Posted | | Count of Participants | | Participants | | Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion | | | | ID | Title | Description |
|---|
| OG000 | Pre-Infusion Toxicity Grade 0 | | | OG001 | Pre-Infusion Toxicity Grade 1 | Body Temperature, Fever (°C) of: 38.0 - 38.4 | | OG002 | Pre-Infusion Toxicity Grade 2 | Body Temperature, Fever (°C) of: 38.5 - 38.9 |
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| 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. | | Posted | | Number | | Participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Intravenous 10% | | | OG001 | Subcutaneous 20% | |
| |
| 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. | Safety Analysis Set (subset of participants aged 2 to 7 years) | Posted | | Median | 95% Confidence Interval | Score on a scale | | Up to 20 months (throughout entire study) | | | | ID | Title | Description |
|---|
| OG000 | Start of Study Epoch 1 | Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | | OG001 | End of Study Epoch 1 | Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | |
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| 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. | Safety Analysis Set participants aged 8 to 13 with scores at each respective time point. | Posted | | Median | 95% Confidence Interval | Score on a scale | | Up to 20 months (throughout entire study) | | | | ID | Title | Description |
|---|
| OG000 | Start of Epoch 1 | Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | | OG001 | End of Epoch 1 | Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | |
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| 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. | Safety Analysis Set participants aged 14 years and older with scores at each respective time point. | Posted | | Median | 95% Confidence Interval | Scores on a scale | | Up to 20 months (throughout entire study) | | | | ID | Title | Description |
|---|
| OG000 | START OF STUDY EPOCH 1 | Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | | OG001 | END OF STUDY EPOCH 1 | Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | | OG002 | END OF STUDY EPOCH 3 | 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. |
|
| 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. | Safety Analysis Set - participants aged 2-12 years old with data (scores) at relevant time points | Posted | | Median | 95% Confidence Interval | Score on a scale | | Up to 20 months per subject (throughout entire study) | | | | ID | Title | Description |
|---|
| OG000 | Start of Epoch 1 | Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | | OG001 | End of Epoch 1 | Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | | OG002 | End of Epoch 3 | 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. |
|
| 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. | Safety Analysis Set - participants aged 13 years and older with data (scores) at relevant time points | Posted | | Median | 95% Confidence Interval | Score on a scale | | Up to 20 months per subject (throughout entire study) | | | | ID | Title | Description |
|---|
| OG000 | Start of Epoch 1 | Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | | OG001 | End of Epoch 1 | Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | | OG002 | End of Epoch 3 | 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. |
|
| 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. | Safety Analysis Set - participants aged 2-12 years old with data (scores) at relevant time points | Posted | | Median | 95% Confidence Interval | Score on a scale | | Up to 20 months (throughout entire study) | | | | ID | Title | Description |
|---|
| OG000 | Start of Epoch 1 | Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | | OG001 | End of Epoch 1 | Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | | OG002 | End of Epoch 3 | 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. |
|
| 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. | Safety Analysis Set - participants aged 13 years and older with data (scores) at relevant time points | Posted | | Median | 95% Confidence Interval | Score on a scale | | Up to 20 months per subject (throughout entire study) | | | | ID | Title | Description |
|---|
| OG000 | Start of Epoch 1 | Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | | OG001 | End of Epoch 1 | Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. | | OG002 | End of Epoch 3 | 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. |
|