Respiratory Syncytial Virus Infection
Conditions
Keywords
Immunocompromised medical conditions, Respiratory Syncytial Virus Infection, Infant, Newborn, Young children
Brief summary
To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions.
Interventions
DRUGPalivizumab
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
Inclusion criteria
1. Availability of parent or legal guardian who is capable and willing to give written informed consent for his/her newborn, infant or young child to participate this study. 2. Japanese newborn, infant or young child at age of 24 months or less. 3. The subject must meet at least one of the following immunocompromised medical conditions (from \[a\] to \[h\]), and must be considered by the investigator to be a suitable candidate to receive prophylactic treatment of palivizumab: 1. Subject has been diagnosed with combined immunodeficiency (severe combined immunodeficiency, X-linked hyper-immunoglobulin M (IgM) syndrome, etc.), antibody deficiency (X-linked agammaglobulinemia, common variable immunodeficiency, non-X-linked hyper-IgM syndrome, etc.) or other immunodeficiency (Wiskott-Aldrich syndrome, DiGeorge syndrome, etc.) at the time of informed consent, or 2. Subject has been diagnosed with human immunodeficiency virus infection, or 3. Subject has been diagnosed with Down syndrome without a current hemodynamically significant congenital heart disease at the time of informed consent (subject must have an experience with persistent respiratory symptom or regular outpatient treatment due to respiratory tract infection prior to current RSV season), or 4. Subject has a history of post organ transplantation at the time of informed consent, or 5. Subject has a history of post bone marrow transplantation at the time of informed consent, or 6. Subject is receiving immunosuppressive chemotherapy at the start of study drug administration, or 7. Subject is receiving systemic high dose corticosteroid therapy (prednisone equivalents 0.5 mg/kg or more every other day, other than inhaler or topical use) at the start of study drug administration, or 8. Subject is receiving other immunosuppressive therapy (azathioprine, methotrexate, mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, cytokine inhibitors, etc.) at the start of study drug administration.
Exclusion criteria
1. Subject who meets one of the palivizumab indications already approved in Japan. * Subject born at 28 weeks of gestation or less and who is age of 12 months or less at the start of study drug administration. * Subject born at 29 - 35 weeks of gestation and who is age of 6 months or less at the start of study drug administration. * Subject is age of 24 months or less with a history of bronchopulmonary dysplasia requiring medical management within the 6 months prior to the study drug administration. * Subject is age of 24 months or less with a current hemodynamically significant congenital heart disease at the start of study drug administration. 2. Subject requires oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support at Screening and at the start of study drug administration. 3. Subject has a current active infection including respiratory syncytial virus infection at Screening and at the start of study drug administration. 4. Subject has a serious concurrent medical condition (hepatic dysfunction, persistent seizure disorder, etc.) except those resulting in an immune deficiency condition or renal failure. 5. Subject has received palivizumab prior to the study drug administration. 6. Subject has received any other investigational agents in the past 3 months or 5 half lives prior to the investigational drug administration (whichever is longer). 7. Subject has a history of an allergic reaction or hypersensitivity to constituents of the study drug. 8. Subject has a history of serious adverse reactions or serious allergic reaction to immunoglobulin products or has a history of hypersensitivity to immunoglobulin products, blood products, or other foreign proteins. 9. Subject whose remaining days of life are expected to be less than one year at the time of informed consent. 10. It will be impossible to collect blood as scheduled from the subject. 11. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121 | Day 1 (Screening), Day 31, Day 121 | Serum trough concentrations of palivizumab were assessed at Screening, at Day 31 (30 days after the 1st dose) and Day 121 (30 days after the 4th dose). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection | From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days. | Percentage of participants who required any of the investigated treatments (admission in the intensive care unit \[ICU\], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug. |
| Duration of Hospitalization Caused by Respiratory Syncytial Virus (RSV) Infection | From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days. | Number of days of hospitalization caused by RSV infection. |
| Duration of Required Treatment for Respiratory Syncytial Virus (RSV) Infection | From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days. | Duration (days) of requirement for any of the investigated treatments (admission in the intensive care unit \[ICU\], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug. |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs | From the first administration of palivizumab to 100 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days. | An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details. |
| Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121 | Baseline (Day 1), Day 121 (30 days after the 4th dose) | — |
| Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121 | Baseline (Day 1), Day 121 (30 days after the 4th dose) | — |
| Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121 | Baseline (Day 1), Day 121 (30 days after the 4th dose) | — |
| Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121 | Baseline (Day 1), Day 121 (30 days after the 4th dose) | — |
| Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (RSV) Infection | From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days. | — |
| Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121 | Baseline (Day 1), Day 121 (30 days after the 4th dose) | Normal range for hemoglobin varied by the monthly age of the participant. |
| Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121 | Baseline (Day 1), Day 121 (30 days after the 4th dose) | Normal range for hematocrit varied by the monthly age of the participant. |
| Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121 | Baseline (Day 1), Day 121 (30 days after the 4th dose) | Normal ranges for WBC, neutrophils, eosinophils, basophils, lymphocytes, and monocytes varied by the monthly age of the participant. |
| Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121 | Baseline (Day 1), Day 121 (30 days after the 4th dose) | Normal ranges for RBC and platelet count varied by the monthly age of the participant. |
| Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121 | Baseline (Day 1), Day 121 (30 days after the 4th dose) | Normal ranges for ALP, AST, and ALT varied by the monthly age of the participant. |
| Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121 | Baseline (Day 1), Day 121 (30 days after the 4th dose) | Normal ranges for total bilirubin, BUN, creatinine, and CRP varied by the monthly age of the participant. |
| Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121 | Screening, Day 121 (30 days after the 4th dose) | The values -, -/+, 1+, 2+, 3+, and 4+ represent a range from none (-) to highest (4+) presence of protein, glucose, and occult blood in the urine. Table presents the number of participants with each value. Those categories with 0 participants to report at either time point are not included in the table below. |
| Mean Baseline and Mean Change From Baseline in Body Weight at Day 121 | Baseline (Day 1), Day 121 (30 days after the 4th dose) | — |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Palivizumab 15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Palivizumab |
|---|---|
| Age Continuous | 14.2 months STANDARD_DEVIATION 6.2 |
| Region of Enrollment Japan | 28 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 28 |
| serious Total, serious adverse events | 7 / 28 |
Outcome results
Primary
Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121
Serum trough concentrations of palivizumab were assessed at Screening, at Day 31 (30 days after the 1st dose) and Day 121 (30 days after the 4th dose).
Time frame: Day 1 (Screening), Day 31, Day 121
Population: All participants; n=number of non-missing observations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palivizumab | Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121 | Day 1 (Screening); n=28 | 0 µg/mL | Standard Deviation 0 |
| Palivizumab | Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121 | Day 31; n=28 | 59.0 µg/mL | Standard Deviation 12.9 |
| Palivizumab | Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121 | Day 121; n=26 | 91.8 µg/mL | Standard Deviation 40.6 |
Secondary
Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121
Normal ranges for ALP, AST, and ALT varied by the monthly age of the participant.
Time frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Population: All participants with measurements at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palivizumab | Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121 | Baseline ALP | 943.0 U/L | Standard Deviation 519.1 |
| Palivizumab | Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121 | Change from Baseline in ALP at Day 121 | -18.0 U/L | Standard Deviation 368.35 |
| Palivizumab | Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121 | Baseline AST | 39.08 U/L | Standard Deviation 12.95 |
| Palivizumab | Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121 | Change from Baseline in AST at Day 121 | 1.54 U/L | Standard Deviation 8.09 |
| Palivizumab | Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121 | Baseline ALT | 31.13 U/L | Standard Deviation 25.7 |
| Palivizumab | Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121 | Change from Baseline in ALT at Day 121 | -3.17 U/L | Standard Deviation 14.07 |
Secondary
Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121
Normal ranges for total bilirubin, BUN, creatinine, and CRP varied by the monthly age of the participant.
Time frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Population: All participants with measurements at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palivizumab | Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121 | Baseline Total Bilirubin | 0.30 mg/dL | Standard Deviation 0.14 |
| Palivizumab | Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121 | Change from Baseline in Total Bilirubin at Day 121 | 0.04 mg/dL | Standard Deviation 0.15 |
| Palivizumab | Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121 | Baseline BUN | 11.46 mg/dL | Standard Deviation 4.52 |
| Palivizumab | Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121 | Change from Baseline in BUN at Day 121 | 0.87 mg/dL | Standard Deviation 4.64 |
| Palivizumab | Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121 | Baseline Creatinine | 0.23 mg/dL | Standard Deviation 0.04 |
| Palivizumab | Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121 | Change from Baseline in Creatinine at Day 121 | 0.01 mg/dL | Standard Deviation 0.04 |
| Palivizumab | Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121 | Baseline CRP | 0.29 mg/dL | Standard Deviation 0.42 |
| Palivizumab | Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121 | Change from Baseline in CRP at Day 121 | 0.03 mg/dL | Standard Deviation 0.62 |
Secondary
Duration of Hospitalization Caused by Respiratory Syncytial Virus (RSV) Infection
Number of days of hospitalization caused by RSV infection.
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Population: Number of participants hospitalized. Since no subject had a RSV infection from the first administration of palivizumab to 30 days after the administration of palivizumab, the number of participants analyzed was 0 for this measure.
Secondary
Duration of Required Treatment for Respiratory Syncytial Virus (RSV) Infection
Duration (days) of requirement for any of the investigated treatments (admission in the intensive care unit \[ICU\], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Population: Number of participants who required any of the investigated treatments for RSV. Since no subject had a RSV infection from the first administration of palivizumab to 30 days after the administration of palivizumab, the number of participants analyzed was 0 for this measure.
Secondary
Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121
Normal range for hematocrit varied by the monthly age of the participant.
Time frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Population: All participants with measurements at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121 | Change from Baseline in Hematocrit at Day 121 | 0.96 percentage of red blood cells | Standard Deviation 5.43 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121 | Baseline Hematocrit | 34.32 percentage of red blood cells | Standard Deviation 4.72 |
Secondary
Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121
Normal range for hemoglobin varied by the monthly age of the participant.
Time frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Population: All participants with measurements at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121 | Baseline Hemoglobin | 11.57 g/dL | Standard Deviation 1.56 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121 | Change from Baseline in Hemoglobin at Day 121 | 0.14 g/dL | Standard Deviation 1.87 |
Secondary
Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121
Normal ranges for RBC and platelet count varied by the monthly age of the participant.
Time frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Population: All participants with measurements at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121 | Baseline Red Blood Cells (RBC) | 410.6 cells *10^4/µL | Standard Deviation 70.83 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121 | Change from Baseline in RBC at Day 121 | 22.3 cells *10^4/µL | Standard Deviation 74.74 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121 | Baseline Platelet Count | 31.29 cells *10^4/µL | Standard Deviation 19.8 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121 | Change from Baseline in Platelet Count at Day 121 | 1.72 cells *10^4/µL | Standard Deviation 18.35 |
Secondary
Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Normal ranges for WBC, neutrophils, eosinophils, basophils, lymphocytes, and monocytes varied by the monthly age of the participant.
Time frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Population: All participants; n=number of participants with measurements at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121 | Baseline White Blood Cells (WBC); n=25 | 6.74 cells *10^3/µL | Standard Deviation 3.93 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121 | Change from Baseline in WBC at Day 121; n=25 | 0.24 cells *10^3/µL | Standard Deviation 2.53 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121 | Baseline (BL) Neutrophils; n=24 | 2.60 cells *10^3/µL | Standard Deviation 2.17 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121 | Change from BL in Neutrophils at Day 121; n=24 | -0.05 cells *10^3/µL | Standard Deviation 1.6 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121 | Baseline Eosinophils; n=24 | 0.25 cells *10^3/µL | Standard Deviation 0.26 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121 | Change from BL in Eosinophils at Day 121; n=24 | -0.0 cells *10^3/µL | Standard Deviation 0.31 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121 | Baseline Basophils; n=24 | 0.04 cells *10^3/µL | Standard Deviation 0.05 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121 | Change from Baseline in Basophils at Day 121; n=24 | 0.02 cells *10^3/µL | Standard Deviation 0.07 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121 | Baseline Lymphocytes; n=24 | 3.36 cells *10^3/µL | Standard Deviation 2.35 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121 | Change from BL in Lymphocytes at Day 121; n=24 | 0.31 cells *10^3/µL | Standard Deviation 1.69 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121 | Baseline Monocytes; n=24 | 0.51 cells *10^3/µL | Standard Deviation 0.44 |
| Palivizumab | Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121 | Change from Baseline in Monocytes at Day 121; n=24 | -0.02 cells *10^3/µL | Standard Deviation 0.38 |
Secondary
Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121
Time frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Population: All participants with measurements at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palivizumab | Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121 | Baseline Body Temperature (BT) | 36.77 degrees Celcius | Standard Deviation 0.346 |
| Palivizumab | Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121 | Change from Baseline in BT at Day 12 | -0.11 degrees Celcius | Standard Deviation 0.4 |
Secondary
Mean Baseline and Mean Change From Baseline in Body Weight at Day 121
Time frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Population: All participants with measurements at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palivizumab | Mean Baseline and Mean Change From Baseline in Body Weight at Day 121 | Baseline Body Weight (BW) | 8.76 kilograms | Standard Deviation 1.9 |
| Palivizumab | Mean Baseline and Mean Change From Baseline in Body Weight at Day 121 | Change from Baseline in BW at Day 121 | 1.23 kilograms | Standard Deviation 0.71 |
Secondary
Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121
Time frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Population: All participants with measurements at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palivizumab | Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121 | Baseline Pulse Rate (PR) | 126.6 beats per minute | Standard Deviation 21.91 |
| Palivizumab | Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121 | Change from Baseline PR at Day 121 | -6.7 beats per minute | Standard Deviation 26.66 |
Secondary
Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121
Time frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Population: All participants with measurements at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palivizumab | Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121 | Baseline Respiratory Rate (RR) | 33.4 respirations per minute | Standard Deviation 8.59 |
| Palivizumab | Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121 | Change from Baseline in RR at Day 121 | 1.5 respirations per minute | Standard Deviation 8.21 |
Secondary
Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121
Time frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Population: All participants; n= number of participants with measurements at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palivizumab | Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121 | Baseline Systolic Blood Pressure (SBP); n=26 | 96.1 mm Hg | Standard Deviation 9.44 |
| Palivizumab | Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121 | Change from Baseline in SBP at Day 121; n=26 | -2.4 mm Hg | Standard Deviation 10.23 |
| Palivizumab | Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121 | Baseline Diastolic Blood Pressure (DBP); n=25 | 55.0 mm Hg | Standard Deviation 9.16 |
| Palivizumab | Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121 | Change from Baseline in DBP at Day 121; n=25 | 3.0 mm Hg | Standard Deviation 14.56 |
Secondary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.
Time frame: From the first administration of palivizumab to 100 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Population: All participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palivizumab | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs | Any AE | 27 participants |
| Palivizumab | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs | Any AE at least possibly drug related | 0 participants |
| Palivizumab | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs | Any AE at least probably not drug related | 7 participants |
| Palivizumab | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs | Any severe AE | 2 participants |
| Palivizumab | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs | Any SAE | 7 participants |
| Palivizumab | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs | Any AE leading to discontinuation of study drug | 1 participants |
| Palivizumab | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs | Any AE leading to death | 0 participants |
| Palivizumab | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs | Death | 0 participants |
Secondary
Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (RSV) Infection
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Population: All participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palivizumab | Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (RSV) Infection | 0 percentage of participants |
Secondary
Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection
Percentage of participants who required any of the investigated treatments (admission in the intensive care unit \[ICU\], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Population: All participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palivizumab | Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection | Intensive-care unit | 0 percentage of participants |
| Palivizumab | Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection | Oxygen supplementation | 0 percentage of participants |
| Palivizumab | Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection | Mechanical ventilation | 0 percentage of participants |
| Palivizumab | Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection | Extracorporeal membrane oxygenation | 0 percentage of participants |
| Palivizumab | Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection | Continuous positive airway pressure | 0 percentage of participants |
| Palivizumab | Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection | Other mechanical respiratory support | 0 percentage of participants |
Secondary
Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
The values -, -/+, 1+, 2+, 3+, and 4+ represent a range from none (-) to highest (4+) presence of protein, glucose, and occult blood in the urine. Table presents the number of participants with each value. Those categories with 0 participants to report at either time point are not included in the table below.
Time frame: Screening, Day 121 (30 days after the 4th dose)
Population: All participants; n=number of participants with measurements at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palivizumab | Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121 | Protein - at Screening; n=24 | 21 participants |
| Palivizumab | Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121 | Protein +/- at Screening; n=24 | 3 participants |
| Palivizumab | Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121 | Protein - at Day 121; n=22 | 21 participants |
| Palivizumab | Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121 | Protein +/- at Day 121; n=22 | 1 participants |
| Palivizumab | Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121 | Glucose - at Screening; n=24 | 24 participants |
| Palivizumab | Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121 | Glucose - at Day 121; n=22 | 22 participants |
| Palivizumab | Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121 | Occult Blood - at Screening; n=24 | 21 participants |
| Palivizumab | Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121 | Occult Blood +/- at Screening; n=24 | 2 participants |
| Palivizumab | Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121 | Occult Blood 1+ at Screening; n=24 | 1 participants |
| Palivizumab | Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121 | Occult Blood - at Day 121; n=22 | 21 participants |
| Palivizumab | Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121 | Occult Blood +/- at Day 121; n=22 | 0 participants |
| Palivizumab | Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121 | Occult Blood 1+ at Day 121; n=22 | 1 participants |