Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the same Respiratory Syncytial Virus (RSV) Season

Study identifier:MI-CP127

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), and Palivizumab when Administered in the Same Season

Medical condition

Respiratory Syncytial Virus Infections, premature with gestational age <=35 weeks and <=6 months of age

Phase

Phase 2

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

260

Study type

Interventional

Age

N/A - 24 Months

Date

Study Start Date: 01 Apr 2006

Primary Completion Date: 01 Feb 2007

Study Completion Date: 01 Feb 2007

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention

Verification:

Verified 01 Nov 2012 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- The child must have been born at less than or equal to 35 weeks gestation and be less than or equal to 6 months of age at the time of entry into the study (child must be entered on or before his/her 6-month birthday); or the child must be less than or equal to 24 months of age at the time of entry into the study (child must be entered on or before his/her 24-month birthday) and diagnosed with chronic lung disease (CLD) of prematurity with stable or decreasing doses of diuretics, steroids, or bronchodilators, or treatment with supplemental oxygen, within the previous 6 months.
- The child must be in general good health at the time of study entry.
- The child’s parent(s)/legal guardian must provide written informed consent.
- The child must be able to complete the follow-up visits through 120-150 days from last injection of study drug.
- Parent(s)/legal guardian of patient must have available telephone access.

Exclusion Criteria

- Hospitalized at the time of study entry (unless discharge is expected within 10 days after entry into the study)
- Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP])
- Congenital heart disease (CHD) (children with medically or surgically corrected [closed] patent ductus arteriosus and no other CHD may be enrolled)
- Evidence of infection with hepatitis A, B, or C virus
- Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection (a child of a mother with known HIV infection must be proven to be uninfected at the time of enrollment)
- Suspected serious allergic or immune-mediated events with prior receipt of palivizumab
- Acute illness or progressive clinical disorder
- Active infection, including acute RSV infection, at the time of enrollment
- Previous reaction to intravenous immunoglobulin (IGIV), blood products, or other foreign proteins
- Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGam], IVIG, or palivizumab) or any investigational agents
- Previous participation in a clinical trial of motavizumab
- Currently participating in any investigational study

Location

Women's and Children's Hospital

North Adelaide, South Australia, Australia, 5006

Location

University of Queensland, Royal Children's Hospital

Herston, QLD, Australia, 4029

Location

Neonatalogy John Hunter Hospital

New Lambton Heights, NSW, Australia, 2305

Location

Department of Paediatrics and Child Health, The Canberra Hospital

Garran, ACT, Australia, 2605

Location

Respiratory Medicine Department, Royal Children's Hospital

Parkville, VIC, Australia, 3052

Location

Peninsula Clinical Research Centre

Kippa-Ring, QLD, Australia, 4021

Location

Caboolture Clinical Research

Caboolture, QLD, Australia, 4510

Location

Child Health, Palmerston North Hospital

Palmerston North, New Zealand

Arms	Assigned Interventions
Experimental: Motavizumab followed by Palivizumab 2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)	Biological/Vaccine: Motavizumab, palivizumab Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.
Experimental: Palivizumab followed by motavizumab 2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)	Biological/Vaccine: Palivizumab, motavizumab Palivizumab was provided in sterile vials containing 100 mg of palivizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine, and 1.6 mM glycine.
Experimental: Motavizumab control 5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)	Biological/Vaccine: Motavizumab Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
It was anticipated that approximately 240 children (80 in each group) would be enrolled from the southern hemisphere during the upcoming RSV season (2006).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Children were randomized into one of three regimens in a 1:1:1 ratio; the first group received 2 doses of motavizumab followed by 3 doses of palivizumab; the second group received 2 doses of palivizumab followed by 3 doses of motavizumab; and the third group received 5 doses of motavizumab.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Participant Flow: Overall Study

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
STARTED	83	84	93
COMPLETED	77	77	87
NOT COMPLETED	6	7	6
Lost to Follow-up	0	1	0
Withdrawal of Consent	3	5	6
Death	2	0	0
not specified	1	1	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Baseline Measures

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control	Total
Number of Participants [units: Participants]	83	84	93	260
Age Continuous [units: months] Mean ± Standard Deviation	3.68 ± 3.13	3.35 ± 2.25	3.92 ± 2.43	3.66 ± 2.62
Gender, Male/Female [units: participants]
Female	32	41	45	118
Male	51	43	48	142

Outcome Measures

1. Primary Outcome Measure: Number of subjects reporting serious adverse events (SAEs) [ Time Frame: Day 0 - Day 150 ]

Measure Type	Primary
Measure Name	Number of subjects reporting serious adverse events (SAEs)
Measure Description
Time Frame	Day 0 - Day 150
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all randomized subjects who received study drug and had any safety follow-up.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	83	83	93
Number of subjects reporting serious adverse events (SAEs) [units: participants]	19	7	11

No statistical analysis provided for Number of subjects reporting serious adverse events (SAEs)

2. Primary Outcome Measure: Number of subjects reporting adverse events (AEs) [ Time Frame: Day 0 - Day 150 ]

Measure Type	Primary
Measure Name	Number of subjects reporting adverse events (AEs)
Measure Description
Time Frame	Day 0 - Day 150
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all randomized subjects who received study drug and had any safety follow-up.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	83	83	93
Number of subjects reporting adverse events (AEs) [units: participants]	77	75	83

No statistical analysis provided for Number of subjects reporting adverse events (AEs)

3. Primary Outcome Measure: Number of subjects with changes in laboratory chemistry values reported as AEs. [ Time Frame: Day 0 - Day 150 ]

Measure Type	Primary
Measure Name	Number of subjects with changes in laboratory chemistry values reported as AEs.
Measure Description	Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.
Time Frame	Day 0 - Day 150
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all randomized subjects who received study drug and had any safety follow-up.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	83	83	93
Number of subjects with changes in laboratory chemistry values reported as AEs. [units: participants]
Alanine aminotransferase increased	1	1	5
Hepatic enzyme increased	1	0	0
Liver function test abnormal	0	0	1
Blood urea increased	1	1	3
Aspartate aminotransferase increased	2	3	2

No statistical analysis provided for Number of subjects with changes in laboratory chemistry values reported as AEs.

4. Secondary Outcome Measure: The serum concentrations of motavizumab at Day 0 [ Time Frame: Day 0 ]

Measure Type	Secondary
Measure Name	The serum concentrations of motavizumab at Day 0
Measure Description
Time Frame	Day 0
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	76	75	85
The serum concentrations of motavizumab at Day 0 [units: μg/mL] Mean (Standard Deviation)	NA (NA)^[1]	NA (NA)^[2]	NA (NA)^[3]

[1]	Values were below the level of detection.
[2]	Values were below the level of detection.
[3]	Values were below the level of detection.

No statistical analysis provided for The serum concentrations of motavizumab at Day 0

5. Secondary Outcome Measure: The trough serum concentrations of motavizumab at Day 60 [ Time Frame: Day 60 ]

Measure Type	Secondary
Measure Name	The trough serum concentrations of motavizumab at Day 60
Measure Description
Time Frame	Day 60
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	67	70	72
The trough serum concentrations of motavizumab at Day 60 [units: μg/mL] Mean (Standard Deviation)	74.74 (27.50)	0.9417 (2.287)	78.02 (28.98)

No statistical analysis provided for The trough serum concentrations of motavizumab at Day 60

6. Secondary Outcome Measure: The trough serum concentrations of motavizumab at Day 150 [ Time Frame: Day 150 ]

Measure Type	Secondary
Measure Name	The trough serum concentrations of motavizumab at Day 150
Measure Description
Time Frame	Day 150
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	53	54	62
The trough serum concentrations of motavizumab at Day 150 [units: μg/mL] Mean (Standard Deviation)	8.801 (5.682)	93.05 (30.97)	105.8 (37.49)

No statistical analysis provided for The trough serum concentrations of motavizumab at Day 150

7. Secondary Outcome Measure: The trough serum concentrations of motavizumab 120-150 days post final dose [ Time Frame: 120-150 days post final dose ]

Measure Type	Secondary
Measure Name	The trough serum concentrations of motavizumab 120-150 days post final dose
Measure Description
Time Frame	120-150 days post final dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	73	72	83
The trough serum concentrations of motavizumab 120-150 days post final dose [units: μg/mL] Mean (Standard Deviation)	0.5078 (1.031)	7.586 (5.152)	10.01 (6.341)

No statistical analysis provided for The trough serum concentrations of motavizumab 120-150 days post final dose

8. Secondary Outcome Measure: The serum concentrations of palivizumab at Day 0 [ Time Frame: Day 0 ]

Measure Type	Secondary
Measure Name	The serum concentrations of palivizumab at Day 0
Measure Description
Time Frame	Day 0
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	73	72	83
The serum concentrations of palivizumab at Day 0 [units: μg/mL] Mean (Standard Deviation)	NA (NA)^[1]	NA (NA)^[2]	NA (NA)^[3]

[1]	Values were below the level of detection.
[2]	Values were below the level of detection.
[3]	Values were below the level of detection.

No statistical analysis provided for The serum concentrations of palivizumab at Day 0

9. Secondary Outcome Measure: The trough serum concentrations of palivizumab at Day 60 [ Time Frame: Day 60 ]

Measure Type	Secondary
Measure Name	The trough serum concentrations of palivizumab at Day 60
Measure Description
Time Frame	Day 60
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	66	66	69
The trough serum concentrations of palivizumab at Day 60 [units: μg/mL] Mean (Standard Deviation)	8.103 (6.907)	87.37 (17.41)	8.795 (6.578)

No statistical analysis provided for The trough serum concentrations of palivizumab at Day 60

10. Secondary Outcome Measure: The trough serum concentrations of palivizumab at Day 150 [ Time Frame: Day 150 ]

Measure Type	Secondary
Measure Name	The trough serum concentrations of palivizumab at Day 150
Measure Description
Time Frame	Day 150
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	52	54	60
The trough serum concentrations of palivizumab at Day 150 [units: μg/mL] Mean (Standard Deviation)	107.4 (30.21)	22.89 (5.631)	12.99 (7.472)

No statistical analysis provided for The trough serum concentrations of palivizumab at Day 150

11. Secondary Outcome Measure: The trough serum concentrations of palivizumab at 120-150 days post final dose [ Time Frame: 120-150 days post final dose ]

Measure Type	Secondary
Measure Name	The trough serum concentrations of palivizumab at 120-150 days post final dose
Measure Description
Time Frame	120-150 days post final dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	72	71	81
The trough serum concentrations of palivizumab at 120-150 days post final dose [units: μg/mL] Mean (Standard Deviation)	7.667 (7.719)	NA (NA)^[1]	NA (NA)^[2]

[1]	Values were below the level of detection.
[2]	Values were below the level of detection.

No statistical analysis provided for The trough serum concentrations of palivizumab at 120-150 days post final dose

12. Secondary Outcome Measure: The immunogenicity of motavizumab at Day 0 [ Time Frame: Day 0 ]

Measure Type	Secondary
Measure Name	The immunogenicity of motavizumab at Day 0
Measure Description	Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame	Day 0
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	77	80	89
The immunogenicity of motavizumab at Day 0 [units: participants with detected antibody]	0	1	0

No statistical analysis provided for The immunogenicity of motavizumab at Day 0

13. Secondary Outcome Measure: The immunogenicity of motavizumab at Day 60 [ Time Frame: Day 60 ]

Measure Type	Secondary
Measure Name	The immunogenicity of motavizumab at Day 60
Measure Description	Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame	Day 60
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	76	82	90
The immunogenicity of motavizumab at Day 60 [units: participants with detected antibody]	0	0	0

No statistical analysis provided for The immunogenicity of motavizumab at Day 60

14. Secondary Outcome Measure: The immunogenicity of motavizumab at Day 150 [ Time Frame: Day 150 ]

Measure Type	Secondary
Measure Name	The immunogenicity of motavizumab at Day 150
Measure Description	Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame	Day 150
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	73	75	84
The immunogenicity of motavizumab at Day 150 [units: participants with detected antibody]	1	1	0

No statistical analysis provided for The immunogenicity of motavizumab at Day 150

15. Secondary Outcome Measure: The immunogenicity of motavizumab at 120 to 150 days post final dose [ Time Frame: 120 - 150 days post final dose ]

Measure Type	Secondary
Measure Name	The immunogenicity of motavizumab at 120 to 150 days post final dose
Measure Description	Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame	120 - 150 days post final dose
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	75	74	84
The immunogenicity of motavizumab at 120 to 150 days post final dose [units: participants with detected antibody]	3	1	0

No statistical analysis provided for The immunogenicity of motavizumab at 120 to 150 days post final dose

16. Secondary Outcome Measure: The immunogenicity of motavizumab at any time [ Time Frame: At any time ]

Measure Type	Secondary
Measure Name	The immunogenicity of motavizumab at any time
Measure Description	Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame	At any time
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	79	83	91
The immunogenicity of motavizumab at any time [units: participants with detected antibody]	4	2	0

No statistical analysis provided for The immunogenicity of motavizumab at any time

17. Secondary Outcome Measure: The immunogenicity of palivizumab at Day 0 [ Time Frame: Day 0 ]

Measure Type	Secondary
Measure Name	The immunogenicity of palivizumab at Day 0
Measure Description	Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame	Day 0
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	76	78	86
The immunogenicity of palivizumab at Day 0 [units: participants with detected antibody]	0	0	0

No statistical analysis provided for The immunogenicity of palivizumab at Day 0

18. Secondary Outcome Measure: The immunogenicity of palivizumab at Day 60 [ Time Frame: Day 60 ]

Measure Type	Secondary
Measure Name	The immunogenicity of palivizumab at Day 60
Measure Description	Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame	Day 60
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	76	82	89
The immunogenicity of palivizumab at Day 60 [units: participants with detected antibody]	1	1	1

No statistical analysis provided for The immunogenicity of palivizumab at Day 60

19. Secondary Outcome Measure: The immunogenicity of palivizumab at Day 150 [ Time Frame: Day 150 ]

Measure Type	Secondary
Measure Name	The immunogenicity of palivizumab at Day 150
Measure Description	Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame	Day 150
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	73	75	84
The immunogenicity of palivizumab at Day 150 [units: participants with detected antibody]	2	1	0

No statistical analysis provided for The immunogenicity of palivizumab at Day 150

20. Secondary Outcome Measure: The immunogenicity of palivizumab at 120 to 150 days post final dose [ Time Frame: 120 - 150 days post final pose ]

Measure Type	Secondary
Measure Name	The immunogenicity of palivizumab at 120 to 150 days post final dose
Measure Description	Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame	120 - 150 days post final pose
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	74	74	83
The immunogenicity of palivizumab at 120 to 150 days post final dose [units: participants with detected antibody]	3	0	0

No statistical analysis provided for The immunogenicity of palivizumab at 120 to 150 days post final dose

21. Secondary Outcome Measure: The immunogenicity of palivizumab at any time [ Time Frame: At any time ]

Measure Type	Secondary
Measure Name	The immunogenicity of palivizumab at any time
Measure Description	Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame	At any time
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Measured Values

	motavizumab (MEDI-524) followed by palivizumab	palivizumab followed by motavizumab (MEDI-524)	motavizumab (MEDI-524) control
Number of Participants Analyzed [units:participants]	82	83	90
The immunogenicity of palivizumab at any time [units: participants with detected antibody]	4	2	1

No statistical analysis provided for The immunogenicity of palivizumab at any time

Serious Adverse Events

Time Frame	Day 0 - Day 150
Additional Description	Safety population

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Serious Adverse Events

motavizumab (MEDI-524) followed by palivizumab

palivizumab followed by motavizumab (MEDI-524)

motavizumab (MEDI-524) control

Total, serious adverse events

# participants affected / at risk

19/83 (22.89%)

7/83 (8.43%)

11/93 (11.83%)

Eye disorders

Visual disturbance¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

0/93 (0.00%)

# events

Gastrointestinal disorders

CONSTIPATION¹,^†

# participants affected / at risk

0/83 (0.00%)

1/93 (1.08%)

# events

Gastrointestinal disorders

GASTROOESOPHAGEAL REFLUX DISEASE¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

0/93 (0.00%)

# events

Gastrointestinal disorders

INFANTILE COLIC¹,^†

# participants affected / at risk

0/83 (0.00%)

1/93 (1.08%)

# events

Gastrointestinal disorders

INGUINAL HERNIA¹,^†

# participants affected / at risk

0/83 (0.00%)

2/83 (2.41%)

1/93 (1.08%)

# events

Gastrointestinal disorders

INTESTINAL OBSTRUCTION¹,^†

# participants affected / at risk

0/83 (0.00%)

1/93 (1.08%)

# events

Infections and infestations

BRONCHIOLITIS¹,^†

# participants affected / at risk

6/83 (7.23%)

1/83 (1.20%)

3/93 (3.23%)

# events

Infections and infestations

BRONCHITIS¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

0/93 (0.00%)

# events

Infections and infestations

BRONCHITIS VIRAL¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

0/93 (0.00%)

# events

Infections and infestations

CROUP INFECTIOUS¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

0/93 (0.00%)

# events

Infections and infestations

GASTROENTERITIS¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

0/93 (0.00%)

# events

Infections and infestations

LOWER RESPIRATORY TRACT INFECTION¹,^†

# participants affected / at risk

0/83 (0.00%)

1/83 (1.20%)

0/93 (0.00%)

# events

Infections and infestations

PARAINFLUENZAE VIRUS INFECTION¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

0/93 (0.00%)

# events

Infections and infestations

PNEUMONIA¹,^†

# participants affected / at risk

3/83 (3.61%)

0/83 (0.00%)

1/93 (1.08%)

# events

Infections and infestations

PNEUMONIA INFLUENZAL¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

0/93 (0.00%)

# events

Infections and infestations

PNEUMONIA PARAINFLUENZAE VIRAL¹,^†

# participants affected / at risk

0/83 (0.00%)

1/93 (1.08%)

# events

Infections and infestations

PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL¹,^†

# participants affected / at risk

0/83 (0.00%)

1/83 (1.20%)

1/93 (1.08%)

# events

Infections and infestations

RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLIT¹,^†

# participants affected / at risk

0/83 (0.00%)

1/93 (1.08%)

# events

Infections and infestations

RESPIRATORY TRACT INFECTION VIRAL¹,^†

# participants affected / at risk

0/83 (0.00%)

1/83 (1.20%)

0/93 (0.00%)

# events

Infections and infestations

SEPSIS¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

0/93 (0.00%)

# events

Infections and infestations

STAPHYLOCOCCAL SCALDED SKIN SYNDROME¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

0/93 (0.00%)

# events

Infections and infestations

UPPER RESPIRATORY TRACT INFECTION¹,^†

# participants affected / at risk

0/83 (0.00%)

1/83 (1.20%)

0/93 (0.00%)

# events

Infections and infestations

VIRAL INFECTION¹,^†

# participants affected / at risk

0/83 (0.00%)

1/83 (1.20%)

0/93 (0.00%)

# events

Investigations

LIVER FUNCTION TEST ABNORMAL¹,^†

# participants affected / at risk

0/83 (0.00%)

1/93 (1.08%)

# events

Respiratory, thoracic and mediastinal disorders

APNOEA¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

1/93 (1.08%)

# events

Respiratory, thoracic and mediastinal disorders

WHEEZING¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

0/93 (0.00%)

# events

Skin and subcutaneous tissue disorders

ERYTHEMA MULTIFORME¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

0/93 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA (11.1)

Other Adverse Events

Time Frame	Day 0 - Day 150
Additional Description	Safety population

Frequency Threshold

Threshold above which other adverse events are reported	2%

Reporting Groups

	Description
motavizumab (MEDI-524) followed by palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
palivizumab followed by motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
motavizumab (MEDI-524) control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Other Adverse Events

motavizumab (MEDI-524) followed by palivizumab

palivizumab followed by motavizumab (MEDI-524)

motavizumab (MEDI-524) control

Total, other (not including serious) adverse events

# participants affected / at risk

75/83 (90.36%)

74/83 (89.16%)

83/93 (89.25%)

Blood and lymphatic system disorders

ANAEMIA¹,^†

# participants affected / at risk

2/83 (2.41%)

6/83 (7.23%)

3/93 (3.23%)

# events

Eye disorders

CONJUNCTIVITIS¹,^†

# participants affected / at risk

6/83 (7.23%)

11/83 (13.25%)

16/93 (17.20%)

# events

Blood and lymphatic system disorders

ANAEMIA NEONATAL¹,^†

# participants affected / at risk

0/83 (0.00%)

1/83 (1.20%)

4/93 (4.30%)

# events

Gastrointestinal disorders

ABDOMINAL PAIN¹,^†

# participants affected / at risk

4/83 (4.82%)

1/83 (1.20%)

3/93 (3.23%)

# events

Gastrointestinal disorders

CONSTIPATION¹,^†

# participants affected / at risk

6/83 (7.23%)

6/93 (6.45%)

# events

Gastrointestinal disorders

DIARRHOEA¹,^†

# participants affected / at risk

12/83 (14.46%)

13/83 (15.66%)

11/93 (11.83%)

# events

Gastrointestinal disorders

FLATULENCE¹,^†

# participants affected / at risk

1/83 (1.20%)

2/83 (2.41%)

3/93 (3.23%)

# events

Gastrointestinal disorders

GASTROOESOPHAGEAL REFLUX DISEASE¹,^†

# participants affected / at risk

4/83 (4.82%)

7/83 (8.43%)

7/93 (7.53%)

# events

Gastrointestinal disorders

INFANTILE COLIC¹,^†

# participants affected / at risk

0/83 (0.00%)

1/83 (1.20%)

2/93 (2.15%)

# events

Gastrointestinal disorders

INGUINAL HERNIA¹,^†

# participants affected / at risk

0/83 (0.00%)

2/83 (2.41%)

4/93 (4.30%)

# events

Gastrointestinal disorders

TEETHING¹,^†

# participants affected / at risk

10/83 (12.05%)

9/83 (10.84%)

16/93 (17.20%)

# events

Gastrointestinal disorders

UMBILICAL HERNIA¹,^†

# participants affected / at risk

1/83 (1.20%)

2/83 (2.41%)

2/93 (2.15%)

# events

Gastrointestinal disorders

VOMITING¹,^†

# participants affected / at risk

2/83 (2.41%)

1/93 (1.08%)

# events

General disorders and administration site conditions

INJECTION SITE ERYTHEMA¹,^†

# participants affected / at risk

3/83 (3.61%)

9/83 (10.84%)

8/93 (8.60%)

# events

General disorders and administration site conditions

IRRITABILITY¹,^†

# participants affected / at risk

10/83 (12.05%)

11/83 (13.25%)

11/93 (11.83%)

# events

General disorders and administration site conditions

PYREXIA¹,^†

# participants affected / at risk

6/83 (7.23%)

8/83 (9.64%)

11/93 (11.83%)

# events

Immune system disorders

IMMUNISATION REACTION¹,^†

# participants affected / at risk

3/83 (3.61%)

4/83 (4.82%)

2/93 (2.15%)

# events

Infections and infestations

BRONCHIOLITIS¹,^†

# participants affected / at risk

6/83 (7.23%)

2/93 (2.15%)

# events

Infections and infestations

BRONCHITIS¹,^†

# participants affected / at risk

14/83 (16.87%)

20/83 (24.10%)

19/93 (20.43%)

# events

Infections and infestations

CANDIDA NAPPY RASH¹,^†

# participants affected / at risk

2/83 (2.41%)

3/83 (3.61%)

2/93 (2.15%)

# events

Infections and infestations

CANDIDIASIS¹,^†

# participants affected / at risk

0/83 (0.00%)

3/83 (3.61%)

1/93 (1.08%)

# events

Infections and infestations

EAR INFECTION¹,^†

# participants affected / at risk

0/83 (0.00%)

2/83 (2.41%)

1/93 (1.08%)

# events

Infections and infestations

GASTROENTERITIS¹,^†

# participants affected / at risk

7/83 (8.43%)

4/83 (4.82%)

5/93 (5.38%)

# events

Infections and infestations

GASTROENTERITIS ROTAVIRUS¹,^†

# participants affected / at risk

2/83 (2.41%)

0/83 (0.00%)

2/93 (2.15%)

# events

Infections and infestations

GENITAL CANDIDIASIS¹,^†

# participants affected / at risk

2/83 (2.41%)

3/83 (3.61%)

1/93 (1.08%)

# events

Infections and infestations

LARYNGITIS¹,^†

# participants affected / at risk

2/83 (2.41%)

3/83 (3.61%)

1/93 (1.08%)

# events

Infections and infestations

LOWER RESPIRATORY TRACT INFECTION¹,^†

# participants affected / at risk

7/83 (8.43%)

6/83 (7.23%)

6/93 (6.45%)

# events

Infections and infestations

NASOPHARYNGITIS¹,^†

# participants affected / at risk

25/83 (30.12%)

26/83 (31.33%)

23/93 (24.73%)

# events

Infections and infestations

ORAL CANDIDIASIS¹,^†

# participants affected / at risk

2/83 (2.41%)

5/83 (6.02%)

2/93 (2.15%)

# events

Infections and infestations

OTITIS MEDIA¹,^†

# participants affected / at risk

4/83 (4.82%)

4/93 (4.30%)

# events

Infections and infestations

OTITIS MEDIA ACUTE¹,^†

# participants affected / at risk

2/83 (2.41%)

0/83 (0.00%)

5/93 (5.38%)

# events

Infections and infestations

PHARYNGITIS¹,^†

# participants affected / at risk

7/83 (8.43%)

4/83 (4.82%)

10/93 (10.75%)

# events

Infections and infestations

RASH PUSTULAR¹,^†

# participants affected / at risk

2/83 (2.41%)

0/83 (0.00%)

2/93 (2.15%)

# events

Infections and infestations

RHINITIS¹,^†

# participants affected / at risk

10/83 (12.05%)

14/83 (16.87%)

8/93 (8.60%)

# events

Infections and infestations

UPPER RESPIRATORY TRACT INFECTION¹,^†

# participants affected / at risk

17/83 (20.48%)

15/83 (18.07%)

18/93 (19.35%)

# events

Infections and infestations

URINARY TRACT INFECTION¹,^†

# participants affected / at risk

0/83 (0.00%)

2/93 (2.15%)

# events

Infections and infestations

VARICELLA¹,^†

# participants affected / at risk

2/83 (2.41%)

2/93 (2.15%)

# events

Infections and infestations

VIRAL INFECTION¹,^†

# participants affected / at risk

3/83 (3.61%)

2/83 (2.41%)

3/93 (3.23%)

# events

Infections and infestations

VIRAL UPPER RESPIRATORY TRACT INFECTION¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

3/93 (3.23%)

# events

Injury, poisoning and procedural complications

CONTUSION¹,^†

# participants affected / at risk

0/83 (0.00%)

1/83 (1.20%)

2/93 (2.15%)

# events

Injury, poisoning and procedural complications

PROCEDURAL PAIN¹,^†

# participants affected / at risk

0/83 (0.00%)

2/83 (2.41%)

1/93 (1.08%)

# events

Investigations

ALANINE AMINOTRANSFERASE INCREASED¹,^†

# participants affected / at risk

1/83 (1.20%)

5/93 (5.38%)

# events

Investigations

ASPARTATE AMINOTRANSFERASE INCREASED¹,^†

# participants affected / at risk

2/83 (2.41%)

3/83 (3.61%)

2/93 (2.15%)

# events

Investigations

BLOOD UREA INCREASED¹,^†

# participants affected / at risk

1/83 (1.20%)

3/93 (3.23%)

# events

Investigations

CARDIAC MURMUR¹,^†

# participants affected / at risk

2/83 (2.41%)

1/83 (1.20%)

2/93 (2.15%)

# events

Nervous system disorders

HYPERTONIA¹,^†

# participants affected / at risk

5/83 (6.02%)

1/83 (1.20%)

0/93 (0.00%)

# events

Nervous system disorders

PSYCHOMOTOR SKILLS IMPAIRED¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

2/93 (2.15%)

# events

Psychiatric disorders

AGITATION¹,^†

# participants affected / at risk

3/83 (3.61%)

2/83 (2.41%)

2/93 (2.15%)

# events

Psychiatric disorders

BREATH HOLDING¹,^†

# participants affected / at risk

2/83 (2.41%)

0/83 (0.00%)

0/93 (0.00%)

# events

Reproductive system and breast disorders

GENITAL RASH¹,^†

# participants affected / at risk

1/83 (1.20%)

2/93 (2.15%)

# events

Respiratory, thoracic and mediastinal disorders

BRONCHIAL HYPERREACTIVITY¹,^†

# participants affected / at risk

0/83 (0.00%)

3/93 (3.23%)

# events

Respiratory, thoracic and mediastinal disorders

COUGH¹,^†

# participants affected / at risk

6/83 (7.23%)

4/83 (4.82%)

5/93 (5.38%)

# events

Respiratory, thoracic and mediastinal disorders

NASAL CONGESTION¹,^†

# participants affected / at risk

7/83 (8.43%)

1/83 (1.20%)

3/93 (3.23%)

# events

Respiratory, thoracic and mediastinal disorders

RHINORRHOEA¹,^†

# participants affected / at risk

3/83 (3.61%)

5/83 (6.02%)

1/93 (1.08%)

# events

Respiratory, thoracic and mediastinal disorders

WHEEZING¹,^†

# participants affected / at risk

15/83 (18.07%)

8/83 (9.64%)

10/93 (10.75%)

# events

Skin and subcutaneous tissue disorders

DERMATITIS ATOPIC¹,^†

# participants affected / at risk

2/83 (2.41%)

3/83 (3.61%)

1/93 (1.08%)

# events

Skin and subcutaneous tissue disorders

DERMATITIS DIAPER¹,^†

# participants affected / at risk

5/83 (6.02%)

10/83 (12.05%)

10/93 (10.75%)

# events

Skin and subcutaneous tissue disorders

DRY SKIN¹,^†

# participants affected / at risk

0/83 (0.00%)

1/83 (1.20%)

4/93 (4.30%)

# events

Skin and subcutaneous tissue disorders

ECZEMA¹,^†

# participants affected / at risk

1/83 (1.20%)

5/83 (6.02%)

4/93 (4.30%)

# events

Skin and subcutaneous tissue disorders

ERYTHEMA¹,^†

# participants affected / at risk

1/83 (1.20%)

2/93 (2.15%)

# events

Skin and subcutaneous tissue disorders

RASH¹,^†

# participants affected / at risk

3/83 (3.61%)

5/83 (6.02%)

4/93 (4.30%)

# events

Skin and subcutaneous tissue disorders

RASH ERYTHEMATOUS¹,^†

# participants affected / at risk

1/83 (1.20%)

0/83 (0.00%)

2/93 (2.15%)

# events

Skin and subcutaneous tissue disorders

SEBORRHOEIC DERMATITIS¹,^†

# participants affected / at risk

4/83 (4.82%)

1/83 (1.20%)

5/93 (5.38%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA (11.1)

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Pamela Griffin
Organization:	MedImmune
Phone	301 398 0000
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

Terramika Bellamy

301-398-0000

clinicaltrialenquiries@medimmune.com

Contact Backup

Mark Eickhoff

301-398-0000

clinicaltrialenquiries@medimmune.com

Investigators

Principal Investigator

Pamela Griffin

MedImmune, LLC

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Women's and Children's Hospital

University of Queensland, Royal Children's Hospital

Neonatalogy John Hunter Hospital

Department of Paediatrics and Child Health, The Canberra Hospital

Respiratory Medicine Department, Royal Children's Hospital

Peninsula Clinical Research Centre

Caboolture Clinical Research

Child Health, Palmerston North Hospital

Trial Results Summaries