Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01466062
• Collaborator: (none)
• Enrollment: 28
• Locations: 6
• Arm: 1
• Duration (Months): 8
• Patients Per Site: 4.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Infection	Drug: Palivizumab	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Multi-center, Open-label, Uncontrolled Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 severe respiratory syncytial virus (RSV) during the RSV season.	Drug: Palivizumab; Other Names: ABT-315 Synagis

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.]

2. 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.

3. 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.

4. 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.

5. 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.

6. 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)]

7. Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121 [Baseline (Day 1), Day 121 (30 days after the 4th dose)]

8. Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121 [Baseline (Day 1), Day 121 (30 days after the 4th dose)]

9. Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121 [Baseline (Day 1), Day 121 (30 days after the 4th dose)]

10. Mean Baseline and Mean Change From Baseline in Body Weight at Day 121 [Baseline (Day 1), Day 121 (30 days after the 4th dose)]

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 24 Months
• Sexes Eligible for Study: All
• Accepts 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:

4. 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

5. Subject has been diagnosed with human immunodeficiency virus infection, or

6. 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

7. Subject has a history of post organ transplantation at the time of informed consent, or

8. Subject has a history of post bone marrow transplantation at the time of informed consent, or

9. Subject is receiving immunosuppressive chemotherapy at the start of study drug administration, or

10. 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

11. 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.

1. 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.

2. Subject has a current active infection including respiratory syncytial virus infection at Screening and at the start of study drug administration.

3. Subject has a serious concurrent medical condition (hepatic dysfunction, persistent seizure disorder, etc.) except those resulting in an immune deficiency condition or renal failure.

4. Subject has received palivizumab prior to the study drug administration.

5. 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).

6. Subject has a history of an allergic reaction or hypersensitivity to constituents of the study drug.

7. 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.

8. Subject whose remaining days of life are expected to be less than one year at the time of informed consent.

9. It will be impossible to collect blood as scheduled from the subject.

10. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 56847	Hyogo		Japan
2	Site Reference ID/Investigator# 56845	Shimotsuke		Japan
3	Site Reference ID/Investigator# 56842	Tokyo		Japan
4	Site Reference ID/Investigator# 56844	Tokyo		Japan
5	Site Reference ID/Investigator# 56846	Tokyo		Japan
6	Site Reference ID/Investigator# 56843	Yokohama		Japan

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Shigeki Hashimoto, PhD, AbbVie GK.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related info

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01466062
• Other Study ID Numbers: M12-420
• First Posted: Nov 6, 2011
• Last Update Posted: Jun 17, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by AbbVie (prior sponsor, Abbott): Immunocompromised medical conditions; Respiratory Syncytial Virus Infection; Infant; Newborn; Young children
• Additional relevant MeSH terms: Virus Diseases; Respiratory Syncytial Virus Infections; Palivizumab

Study Results

Participant Flow

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Period Title: Overall Study
STARTED	28
COMPLETED	26
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Overall Participants	28
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	14.2 (6.20)
Sex: Female, Male (Count of Participants)
Female	11 39.3%
Male	17 60.7%
Region of Enrollment (participants) [Number]
Japan	28 100%

Outcome Measures

1. Primary Outcome

Title	Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121
Description	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

Outcome Measure Data

Analysis Population Description

All participants; n=number of non-missing observations.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	28
Day 1 (Screening); n=28	0 (0)
Day 31; n=28	59.0 (12.9)
Day 121; n=26	91.8 (40.6)

2. Secondary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

All participants

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	28
Number (95% Confidence Interval) [percentage of participants]	0 0%

3. Secondary Outcome

Title	Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection
Description	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.

Outcome Measure Data

Analysis Population Description

All participants

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	28
Intensive-care unit	0 0%
Oxygen supplementation	0 0%
Mechanical ventilation	0 0%
Extracorporeal membrane oxygenation	0 0%
Continuous positive airway pressure	0 0%
Other mechanical respiratory support	0 0%

4. Secondary Outcome

Title	Duration of Hospitalization Caused by Respiratory Syncytial Virus (RSV) Infection
Description	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.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	0

5. Secondary Outcome

Title	Duration of Required Treatment for Respiratory Syncytial Virus (RSV) Infection
Description	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.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	0

6. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Description	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.

Outcome Measure Data

Analysis Population Description

All participants

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	28
Any AE	27 96.4%
Any AE at least "possibly" drug related	0 0%
Any AE at least "probably not" drug related	7 25%
Any "severe" AE	2 7.1%
Any SAE	7 25%
Any AE leading to discontinuation of study drug	1 3.6%
Any AE leading to death	0 0%
Death	0 0%

7. Secondary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

All participants; n= number of participants with measurements at given time points.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	28
Baseline Systolic Blood Pressure (SBP); n=26	96.1 (9.44)
Change from Baseline in SBP at Day 121; n=26	-2.4 (10.23)
Baseline Diastolic Blood Pressure (DBP); n=25	55.0 (9.16)
Change from Baseline in DBP at Day 121; n=25	3.0 (14.56)

8. Secondary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

All participants with measurements at given time points.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	26
Baseline Body Temperature (BT)	36.77 (0.346)
Change from Baseline in BT at Day 12	-0.11 (0.400)

9. Secondary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

All participants with measurements at given time points.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	26
Baseline Respiratory Rate (RR)	33.4 (8.59)
Change from Baseline in RR at Day 121	1.5 (8.21)

10. Secondary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

All participants with measurements at given time points.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	26
Baseline Pulse Rate (PR)	126.6 (21.91)
Change from Baseline PR at Day 121	-6.7 (26.66)

11. Secondary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

All participants with measurements at given time points.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	26
Baseline Body Weight (BW)	8.76 (1.90)
Change from Baseline in BW at Day 121	1.23 (0.71)

12. Secondary Outcome

Title	Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121
Description	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)

Outcome Measure Data

Analysis Population Description

All participants with measurements at given time points.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	25
Baseline Hemoglobin	11.57 (1.56)
Change from Baseline in Hemoglobin at Day 121	0.14 (1.87)

13. Secondary Outcome

Title	Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121
Description	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)

Outcome Measure Data

Analysis Population Description

All participants with measurements at given time points.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	25
Baseline Hematocrit	34.32 (4.72)
Change from Baseline in Hematocrit at Day 121	0.96 (5.43)

14. Secondary Outcome

Title	Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Description	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)

Outcome Measure Data

Analysis Population Description

All participants; n=number of participants with measurements at given time points.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	28
Baseline White Blood Cells (WBC); n=25	6.74 (3.93)
Change from Baseline in WBC at Day 121; n=25	0.24 (2.53)
Baseline (BL) Neutrophils; n=24	2.60 (2.17)
Change from BL in Neutrophils at Day 121; n=24	-0.05 (1.60)
Baseline Eosinophils; n=24	0.25 (0.26)
Change from BL in Eosinophils at Day 121; n=24	-0.0 (0.31)
Baseline Basophils; n=24	0.04 (0.05)
Change from Baseline in Basophils at Day 121; n=24	0.02 (0.07)
Baseline Lymphocytes; n=24	3.36 (2.35)
Change from BL in Lymphocytes at Day 121; n=24	0.31 (1.69)
Baseline Monocytes; n=24	0.51 (0.44)
Change from Baseline in Monocytes at Day 121; n=24	-0.02 (0.38)

15. Secondary Outcome

Title	Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121
Description	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)

Outcome Measure Data

Analysis Population Description

All participants with measurements at given time points.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	25
Baseline Red Blood Cells (RBC)	410.6 (70.83)
Change from Baseline in RBC at Day 121	22.3 (74.74)
Baseline Platelet Count	31.29 (19.80)
Change from Baseline in Platelet Count at Day 121	1.72 (18.35)

16. Secondary Outcome

Title	Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121
Description	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)

Outcome Measure Data

Analysis Population Description

All participants with measurements at given time points.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	24
Baseline ALP	943.0 (519.10)
Change from Baseline in ALP at Day 121	-18.0 (368.35)
Baseline AST	39.08 (12.95)
Change from Baseline in AST at Day 121	1.54 (8.09)
Baseline ALT	31.13 (25.70)
Change from Baseline in ALT at Day 121	-3.17 (14.07)

17. Secondary Outcome

Title	Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121
Description	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)

Outcome Measure Data

Analysis Population Description

All participants with measurements at given time points.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	24
Baseline Total Bilirubin	0.30 (0.14)
Change from Baseline in Total Bilirubin at Day 121	0.04 (0.15)
Baseline BUN	11.46 (4.52)
Change from Baseline in BUN at Day 121	0.87 (4.64)
Baseline Creatinine	0.23 (0.04)
Change from Baseline in Creatinine at Day 121	0.01 (0.04)
Baseline CRP	0.29 (0.42)
Change from Baseline in CRP at Day 121	0.03 (0.62)

18. Secondary Outcome

Title	Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
Description	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)

Outcome Measure Data

Analysis Population Description

All participants; n=number of participants with measurements at given time points.

Arm/Group Title	Palivizumab
Arm/Group Description	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.
Measure Participants	28
Protein "-" at Screening; n=24	21 75%
Protein "+/-" at Screening; n=24	3 10.7%
Protein "-" at Day 121; n=22	21 75%
Protein "+/-" at Day 121; n=22	1 3.6%
Glucose "-" at Screening; n=24	24 85.7%
Glucose "-" at Day 121; n=22	22 78.6%
Occult Blood "-" at Screening; n=24	21 75%
Occult Blood "+/-" at Screening; n=24	2 7.1%
Occult Blood "1+" at Screening; n=24	1 3.6%
Occult Blood "-" at Day 121; n=22	21 75%
Occult Blood "+/-" at Day 121; n=22	0 0%
Occult Blood "1+" at Day 121; n=22	1 3.6%

Adverse Events

Time Frame	AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
Arm/Group Title	Palivizumab
Arm/Group Description	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.
All Cause Mortality
	Palivizumab
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Palivizumab
	Affected / at Risk (%)	# Events
Total	7/28 (25%)
Gastrointestinal disorders
Duodenal Stenosis	1/28 (3.6%)
Enterocolitis	1/28 (3.6%)
Gastrointestinal Perforation	1/28 (3.6%)
Infections and infestations
Bronchitis	2/28 (7.1%)
Croup Infectious	1/28 (3.6%)
Infectious Peritonitis	1/28 (3.6%)
Pneumonia	1/28 (3.6%)
Pneumonia Bacterial	1/28 (3.6%)
Gastroenteritis	3/28 (10.7%)
Nervous system disorders
Encephalopathy	1/28 (3.6%)
Other (Not Including Serious) Adverse Events
	Palivizumab
	Affected / at Risk (%)	# Events
Total	27/28 (96.4%)
Blood and lymphatic system disorders
Febrile Neutropenia	1/28 (3.6%)
Hypercoagulation	1/28 (3.6%)
Iron Deficiency Anaemia	1/28 (3.6%)
Leukopenia	3/28 (10.7%)
Thrombocytopenia	4/28 (14.3%)
Anaemia	4/28 (14.3%)
Congenital, familial and genetic disorders
Antithrombin III Deficiency	1/28 (3.6%)
Eye disorders
Conjunctivitis	2/28 (7.1%)
Gastrointestinal disorders
Diarrhoea	3/28 (10.7%)
Dyspepsia	1/28 (3.6%)
Enterocolitis	1/28 (3.6%)
Mouth Haemorrhage	1/28 (3.6%)
Rectal Prolapse	1/28 (3.6%)
Stomatitis	1/28 (3.6%)
Constipation	1/28 (3.6%)
General disorders
Pyrexia	3/28 (10.7%)
Hepatobiliary disorders
Hepatic Function Abnormal	4/28 (14.3%)
Immune system disorders
Hypogammaglobulinaemia	5/28 (17.9%)
Infections and infestations
Bronchitis	4/28 (14.3%)
Conjunctivitis Infective	1/28 (3.6%)
Cystitis	2/28 (7.1%)
Exanthema Subitum	1/28 (3.6%)
Gastroenteritis	7/28 (25%)
Gastroenteritis Viral	1/28 (3.6%)
Impetigo	1/28 (3.6%)
Influenza	6/28 (21.4%)
Molluscum Contagiosum	1/28 (3.6%)
Nasopharyngitis	5/28 (17.9%)
Otitis Media	2/28 (7.1%)
Otitis Media Acute	1/28 (3.6%)
Pharyngitis	3/28 (10.7%)
Pseudomonas Infection	1/28 (3.6%)
Respiratory Tract Infection	1/28 (3.6%)
Rhinitis	1/28 (3.6%)
Rotavirus Infection	1/28 (3.6%)
Sinusitis	1/28 (3.6%)
Tinea Cruris	1/28 (3.6%)
Tonsillitis	1/28 (3.6%)
Upper Respiratory Tract Infection	10/28 (35.7%)
Upper Respiratory Tract Infection Bacterial	1/28 (3.6%)
Viral Infection	1/28 (3.6%)
Injury, poisoning and procedural complications
Arthropod Sting	1/28 (3.6%)
Contusion	1/28 (3.6%)
Excoriation	1/28 (3.6%)
Radiation Skin Injury	1/28 (3.6%)
Subcutaneous Haematoma	1/28 (3.6%)
Thermal Burn	1/28 (3.6%)
Investigations
Antithrombin III Decreased	1/28 (3.6%)
Bacterial Test Positive	1/28 (3.6%)
C-Reactive Protein Increased	2/28 (7.1%)
Neutrophil Count Decreased	1/28 (3.6%)
Neutrophil Count Increased	1/28 (3.6%)
White Blood Cell Count Increased	1/28 (3.6%)
White Blood Cells Urine Positive	1/28 (3.6%)
Metabolism and nutrition disorders
Hypoalbuminaemia	2/28 (7.1%)
Musculoskeletal and connective tissue disorders
Muscular Weakness	1/28 (3.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma	1/28 (3.6%)
Nervous system disorders
Febrile Convulsion	1/28 (3.6%)
Renal and urinary disorders
Azotaemia	1/28 (3.6%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/28 (3.6%)
Bronchitis Chronic	1/28 (3.6%)
Respiratory Depression	1/28 (3.6%)
Rhinorrhoea	2/28 (7.1%)
Skin and subcutaneous tissue disorders
Dermatitis Allergic	1/28 (3.6%)
Dermatitis Atopic	1/28 (3.6%)
Dermatitis Contact	2/28 (7.1%)
Dermatitis Diaper	5/28 (17.9%)
Dry Skin	1/28 (3.6%)
Eczema	9/28 (32.1%)
Eczema Asteatotic	4/28 (14.3%)
Eczema Infantile	3/28 (10.7%)
Erythema	1/28 (3.6%)
Hyperkeratosis Palmaris And Plantaris	1/28 (3.6%)
Rash	5/28 (17.9%)
Urticaria	1/28 (3.6%)

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.