A Study to Evaluate a Single Intravenous Dose of Motavizu... | NCT00421304

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants will receive a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Other: Placebo
Motavizumab 30 mg/kg	Experimental	Participants will receive a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Biological: Motavizumab
Motavizumab 100 mg/kg	Experimental	Participants will receive a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.	Biological: Motavizumab

Name	Type	Description	Arm Group Labels	Other Names
Motavizumab	Biological	A single IV dose of motavizumab 30 mg/kg or 100 mg/kg will be administered on Day 0 of the study.	Motavizumab 100 mg/kg Motavizumab 30 mg/kg

Measure	Description	Time Frame
Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0	The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children less than or equal to (<=12) months of age who are hospitalized with lower respiratory tract illness.	Day 0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1	The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.	Day 1
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2	The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.	Day 2
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3	The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.	Day 3
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4	The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.	Day 4

Measure	Description	Time Frame
Duration of RSV Hospitalization	Duration of RSV hospitalization is reported.	From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Respiratory Assessment Change Score (RACS) Derived From Baseline

Name	Affiliation	Role
M. Pamela Griffin, M.D.	MedImmune LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Tucson	Arizona	85724	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
24356256	Derived	Ramilo O, Lagos R, Saez-Llorens X, Suzich J, Wang CK, Jensen KM, Harris BS, Losonsky GA, Griffin MP; Motavizumab Study Group. Motavizumab treatment of infants hospitalized with respiratory syncytial virus infection does not decrease viral load or severity of illness. Pediatr Infect Dis J. 2014 Jul;33(7):703-9. doi: 10.1097/INF.0000000000000240.

ID	Title	Description
FG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
FG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.

Primary

Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0

The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children less than or equal to (<=12) months of age who are hospitalized with lower respiratory tract illness.

The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 0 were analyzed for this outcome.

Posted

Mean

Standard Deviation

log10 copies/mL

Day 0

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants	OG00037 OG00139 OG00236

Title

Denominators

Categories

Title	Measurements
	OG0008.13± 0.73 OG0018.05± 1.22 OG0028.15± 0.86

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon's rank-sum test		0.218														Superiority
OG000 OG002		Wilcoxon's rank-sum test		0.643

Primary

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1

The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.

The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 1 were analyzed for this outcome.

Posted

Mean

Standard Deviation

log10 copies/mL

Day 1

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units

Primary

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2

The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.

The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 2 were analyzed for this outcome.

Posted

Mean

Standard Deviation

log10 copies/mL

Day 2

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units

Primary

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3

The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.

The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 3 were analyzed for this outcome.

Posted

Mean

Standard Deviation

log10 copies/mL

Day 3

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units

Primary

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4

The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.

The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples, who tested positive for RSV at Day 4 were analyzed for this outcome.

Posted

Mean

Standard Deviation

log10 copies/mL

Day 4

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units

Primary

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5

The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.

The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples, who tested positive for RSV at Day 5 were analyzed for this outcome.

Posted

Mean

Standard Deviation

log10 copies/mL

Day 5

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units

Primary

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6

The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.

The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples, who tested positive for RSV at Day 6 were analyzed for this outcome.

Posted

Mean

Standard Deviation

log10 copies/mL

Day 6

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units

Primary

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7

The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.

The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 7 were analyzed for this outcome.

Posted

Mean

Standard Deviation

log10 copies/mL

Day 7

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units

Primary

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30

The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.

The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 30 were analyzed for this outcome.

Posted

Mean

Standard Deviation

log10 copies/mL

Day 30

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units

Primary

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90

The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.

The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 90 were analyzed for this outcome.

Posted

Mean

Standard Deviation

log10 copies/mL

Day 90

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units

Primary

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180

The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.

The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 180 were analyzed for this outcome.

Posted

Mean

Standard Deviation

log10 copies/mL

Day 180

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units

Primary

Motavizumab Concentration in Nasal Wash Aspirates at Day 0

Motavizumab concentration in nasal wash aspirates is reported.

Evaluable population for pharmacokinetics (PK) included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 0 were analyzed for the outcome.

Posted

Mean

Standard Deviation

ng/mL

Day 0

ID	Title	Description
OG000	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG001	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants	OG000

Primary

Motavizumab Concentration in Nasal Wash Aspirates at Day 1

Motavizumab concentration in nasal wash aspirates is reported.

Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 1 were analyzed for the outcome.

Posted

Mean

Standard Deviation

ng/mL

Day 1

ID	Title	Description
OG000	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG001	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants	OG000

Primary

Motavizumab Concentration in Nasal Wash Aspirates at Day 2

Motavizumab concentration in nasal wash aspirates is reported.

Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 2 were analyzed for the outcome.

Posted

Mean

Standard Deviation

ng/mL

Day 2

ID	Title	Description
OG000	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG001	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants	OG000

Primary

Motavizumab Concentration in Nasal Wash Aspirates at Day 7

Motavizumab concentration in nasal wash aspirates is reported.

Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 7 were analyzed for the outcome.

Posted

Mean

Standard Deviation

ng/mL

Day 7

ID	Title	Description
OG000	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG001	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants	OG000

Primary

Motavizumab Concentration in Nasal Wash Aspirates at Day 30

Motavizumab concentration in nasal wash aspirates is reported.

Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 30 were analyzed for the outcome.

Posted

Mean

Standard Deviation

ng/mL

Day 30

ID	Title	Description
OG000	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG001	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants	OG000

Secondary

Duration of RSV Hospitalization

Duration of RSV hospitalization is reported.

RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR.

Posted

Mean

Standard Deviation

Days

From Randomization Day (Day 0) to Discharge Day (up to Day 30)

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants

Secondary

Respiratory Assessment Change Score (RACS) Derived From Baseline

The RACS assesses changes in wheezing and retractions as measured by respiratory distress assessment instrument (RDAI) score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of less than or equal to (<=) 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as arithmetic sum of RDAI score change and of standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in RACS represents improvement, whereas an increase signifies deterioration.

RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Here, 'Number Analyzed' denotes those participants who were evaluable at the specific time point.

Posted

Mean

Standard Deviation

Units on a score

Baseline (Day 0), Days 1, 2, 3, 7, and 30

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg

Secondary

Oxygen Saturation Level During RSV Hospitalization

Oxygen saturation level during RSV hospitalization is reported.

RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Here, 'Number Analyzed' denotes those participants who were evaluable at the specific time point.

Posted

Mean

Standard Deviation

Percentage of oxygen saturation

Days 0, 1, 2, 3, 7, and 30

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants

Secondary

Heart Rate During RSV Hospitalization

Heart rate during RSV hospitalization is reported.

RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Here, 'Number Analyzed' denotes those participants who were evaluable at the specific time point.

Posted

Mean

Standard Deviation

Beats per minute

Days 0, 1, 2, 3, 7, and 30

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants

Secondary

Respiratory Rate During RSV Hospitalization

Respiratory rate during RSV hospitalization is reported.

RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Here, 'Number Analyzed' denotes those participants who were evaluable at the specific time point.

Posted

Mean

Standard Deviation

Breaths per minute

Days 0, 1, 2, 3, 7, and 30

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants

Secondary

Number of Participants With Supplemental Oxygen Use During RSV Hospitalization

Number of participants with supplemental oxygen use during RSV hospitalization is reported.

RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with hospitalization information available were analyzed for this outcome.

Posted

Count of Participants

Participants

From Randomization Day (Day 0) to Discharge Day (up to Day 30)

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts

Secondary

Duration of Supplemental Oxygen Use During RSV Hospitalization

Duration of supplemental oxygen use during RSV hospitalization is reported.

RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants who received supplemental oxygen during RSV hospitalization were analyzed for this outcome.

Posted

Mean

Standard Deviation

Days

From Randomization Day (Day 0) to Discharge Day (up to Day 30)

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants

Secondary

Number of Participants on Mechanical Ventilation During RSV Hospitalization

Number of participants on mechanical ventilation during RSV hospitalization is reported.

RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with hospitalization information available were analyzed for this outcome.

Posted

Count of Participants

Participants

From Randomization Day (Day 0) to Discharge Day (up to Day 30)

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts

Secondary

Duration of Mechanical Ventilation During RSV Hospitalization

Duration of mechanical ventilation during RSV hospitalization is reported.

RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants who received mechanical ventilation during RSV hospitalization were analyzed for this outcome.

Posted

Mean

Standard Deviation

Days

From Randomization Day (Day 0) to Discharge Day (up to Day 30)

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants

Secondary

Number of Participants Admitted to the Intensive Care Unit (ICU)

Number of participants admitted to ICU is reported.

RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with hospitalization information available were analyzed for this outcome.

Posted

Count of Participants

Participants

From Randomization Day (Day 0) to Discharge Day (up to Day 30)

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants

Secondary

Duration of ICU Stay During RSV Hospitalization

Duration of ICU stay during RSV hospitalization is reported.

RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants who were admitted to ICU were analyzed for this outcome.

Posted

Mean

Standard Deviation

Days

From Randomization Day (Day 0) to Discharge Day (up to Day 30)

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants

Secondary

Number of Participants With Medically-attended Wheezing Episodes

Wheezing episodes are considered medically-attended wheezing episodes if the medical care provider verifies and documents wheezing in the medical record or, in the case of hospitalization, the medical care provider assigns a discharge diagnosis of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode is the one that occurs for more than 2 weeks after the diagnosis of the previous episode and the medical opinion is that the wheezing does not represent a persistence of the previous episode. Medically-attended wheezing episodes were calculated and reported in the range of 0 to 9 events.

RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR.

Posted

Number

Participants

From randomization (Day 0) through Day 360 (approximately 12 months)

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Secondary

Serum Concentration of Motavizumab

Motavizumab concentration in serum is reported.

Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in serum at the specified time points were analyzed for this outcome.

Posted

Mean

Standard Deviation

mcg/mL

Days 1, 7, 90, 180, and 360

ID	Title	Description
OG000	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG001	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Detectable Anti-motavizumab Antibodies

Number of participants with detectable anti-motavizumab antibodies are reported. Detection is defined as an anti-motavizumab antibody titer with a dilution value of 1:30 or greater.

Evaluable population for anti-drug antibody included all participants who received a full dose of study drug. Participants with adequate anti-motavizumab antibody titer samples at the specified time points were analyzed for this outcome measure.

Posted

Count of Participants

Participants

Days 0, 180, and 360

ID	Title	Description
OG000	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG001	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Cytokine Levels

RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with adequate cytokine levels were analyzed for this outcome.

Posted

Mean

Standard Deviation

Picograms per millilitre (pg/mL)

Baseline (Day 0, pre-dose) through Day 360

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants

Secondary

Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels

Change from baseline in upper respiratory tract (nasal wash) cytokine levels are reported.

RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with adequate nasal wash cytokine levels at specified time points were analysed for this outcome.

Posted

Mean

Standard Deviation

pg/mL

Baseline (Day 0, pre-dose) through Day 180

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts

Secondary

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Safety population included all the participants who received any dose of study drug.

Posted

Count of Participants

Participants

From the start of study drug (Day 0) through Day 90

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg

Secondary

Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs

Safety population included all the participants who received any dose of study drug.

Posted

Count of Participants

Participants

From the start of study drug (Day 0) through Day 30

ID	Title	Description
OG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
OG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
OG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Units	Counts
Participants	OG000

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected38 at risk EG0020 events0 affected38 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected38 at risk EG0021 events1 affected38 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected38 at risk EG0020 events0 affected38 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected38 at risk EG0021 events1 affected38 at risk
Otitis media acute	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected38 at risk EG0020 events0 affected38 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected37 at risk EG0010 events0 affected38 at risk EG0020 events0 affected38 at risk
Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected38 at risk EG0021 events1 affected38 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected38 at risk EG0021 events1 affected38 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected38 at risk EG0020 events0 affected38 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected38 at risk EG0022 events1 affected38 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected38 at risk EG0020 events0 affected38 at risk
Bronchiolitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected38 at risk EG0021 events1 affected38 at risk
Bronchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected38 at risk EG0020 events0 affected38 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected38 at risk EG0021 events1 affected38 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected38 at risk EG0020 events0 affected38 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected38 at risk EG0021 events1 affected38 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected38 at risk EG0020 events0 affected38 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected37 at risk EG0012 events2 affected38 at risk EG0021 events1 affected38 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected38 at risk EG0021 events1 affected38 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0002 events1 affected37 at risk EG0013 events3 affected38 at risk EG0021 events1 affected38 at risk
Conjunctivitis	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected37 at risk EG0012 events2 affected38 at risk EG0023 events3 affected38 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected37 at risk EG0012 events2 affected38 at risk EG0020 events0 affected38 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected37 at risk EG0010 events0 affected38 at risk EG0020 events0 affected38 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 events2 affected37 at risk EG0014 events4 affected38 at risk EG0023 events3 affected38 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 events5 affected37 at risk EG0014 events4 affected38 at risk EG0022 events2 affected38 at risk
Bronchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00014 events9 affected37 at risk EG0016 events4 affected38 at risk EG0027 events5 affected38 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected37 at risk EG0012 events2 affected38 at risk EG0020 events0 affected38 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected37 at risk EG0014 events3 affected38 at risk EG0020 events0 affected38 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected37 at risk EG0013 events2 affected38 at risk EG0021 events1 affected38 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected37 at risk EG0011 events1 affected38 at risk EG0022 events2 affected38 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG00010 events10 affected37 at risk EG0017 events6 affected38 at risk EG0027 events6 affected38 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected37 at risk EG00110 events8 affected38 at risk EG0024 events4 affected38 at risk
Otitis media	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected37 at risk EG0012 events2 affected38 at risk EG0024 events4 affected38 at risk
Otitis media acute	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected38 at risk EG0024 events3 affected38 at risk
Pharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected37 at risk EG0012 events2 affected38 at risk EG0021 events1 affected38 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0006 events6 affected37 at risk EG0011 events1 affected38 at risk EG0022 events2 affected38 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected37 at risk EG0011 events1 affected38 at risk EG0022 events2 affected38 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected37 at risk EG0010 events0 affected38 at risk EG0023 events3 affected38 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected37 at risk EG0011 events1 affected38 at risk EG0021 events1 affected38 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected37 at risk EG0012 events2 affected38 at risk EG0024 events4 affected38 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected38 at risk EG0023 events3 affected38 at risk

ID	Title	Description
BG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
BG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
BG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	37	6	37	30	37
EG001	Motavizumab 30 mg/kg	Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	38	6	38	22	38
EG002	Motavizumab 100 mg/kg	Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.	38	7	38	24	38