Trial Outcomes & Findings for A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness (NCT NCT00421304)

NCT ID: NCT00421304

Last Updated: 2021-08-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 118 participants
• Primary outcome timeframe: Day 0
• Results posted on: 2021-08-27

Participant Flow

Participant milestones

Measure	Placebo Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Overall Study STARTED	40	39	39
Overall Study COMPLETED	32	35	31
Overall Study NOT COMPLETED	8	4	8

Reasons for withdrawal

Measure	Placebo Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Overall Study Lost to Follow-up	5	2	5
Overall Study Withdrawal by Subject	2	2	2
Overall Study Mistakenly randomized, chose not to participate in study	1	0	0
Overall Study Did not attend Day 360 visit	0	0	1

Baseline Characteristics

A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness

Baseline characteristics by cohort

Measure	Placebo n=40 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=39 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=39 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.	Total n=118 Participants Total of all reporting groups
Age, Continuous	3.72 Months STANDARD_DEVIATION 2.90 • n=5 Participants	3.07 Months STANDARD_DEVIATION 2.62 • n=7 Participants	3.47 Months STANDARD_DEVIATION 2.98 • n=5 Participants	3.42 Months STANDARD_DEVIATION 2.83 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	49 Participants n=4 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	69 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants	35 Participants n=7 Participants	32 Participants n=5 Participants	96 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	26 Participants n=7 Participants	27 Participants n=5 Participants	79 Participants n=4 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	24 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 0

Population: 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.

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.

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=39 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=36 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
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	8.13 log10 copies/mL Standard Deviation 0.73	8.05 log10 copies/mL Standard Deviation 1.22	8.15 log10 copies/mL Standard Deviation 0.86

PRIMARY outcome

Timeframe: Day 1

Population: 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.

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.

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=36 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1	7.61 log10 copies/mL Standard Deviation 0.86	7.54 log10 copies/mL Standard Deviation 1.26	7.40 log10 copies/mL Standard Deviation 1.26

PRIMARY outcome

Timeframe: Day 2

Population: 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.

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.

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=36 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2	6.95 log10 copies/mL Standard Deviation 1.21	6.68 log10 copies/mL Standard Deviation 1.21	6.59 log10 copies/mL Standard Deviation 1.35

PRIMARY outcome

Timeframe: Day 3

Population: 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.

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.

Outcome measures

Measure	Placebo n=34 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=32 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3	6.12 log10 copies/mL Standard Deviation 1.15	6.11 log10 copies/mL Standard Deviation 1.26	5.95 log10 copies/mL Standard Deviation 1.46

PRIMARY outcome

Timeframe: Day 4

Population: 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.

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.

Outcome measures

Measure	Placebo n=10 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=10 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=15 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4	6.00 log10 copies/mL Standard Deviation 0.58	5.76 log10 copies/mL Standard Deviation 0.82	5.41 log10 copies/mL Standard Deviation 1.44

PRIMARY outcome

Timeframe: Day 5

Population: 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.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=8 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=8 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5	5.52 log10 copies/mL Standard Deviation 0.68	5.26 log10 copies/mL Standard Deviation 1.20	5.31 log10 copies/mL Standard Deviation 1.94

PRIMARY outcome

Timeframe: Day 6

Population: 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.

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.

Outcome measures

Measure	Placebo n=5 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=5 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=5 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6	5.63 log10 copies/mL Standard Deviation 0.91	5.25 log10 copies/mL Standard Deviation 1.58	5.60 log10 copies/mL Standard Deviation 2.08

PRIMARY outcome

Timeframe: Day 7

Population: 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.

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.

Outcome measures

Measure	Placebo n=35 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=37 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=36 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7	4.86 log10 copies/mL Standard Deviation 1.45	4.73 log10 copies/mL Standard Deviation 1.27	4.52 log10 copies/mL Standard Deviation 1.70

PRIMARY outcome

Timeframe: Day 30

Population: 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.

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.

Outcome measures

Measure	Placebo n=35 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=37 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=34 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30	3.03 log10 copies/mL Standard Deviation 1.11	3.05 log10 copies/mL Standard Deviation 1.33	2.96 log10 copies/mL Standard Deviation 1.08

PRIMARY outcome

Timeframe: Day 90

Population: 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.

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.

Outcome measures

Measure	Placebo n=33 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=37 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=34 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90	2.66 log10 copies/mL Standard Deviation 0.70	2.55 log10 copies/mL Standard Deviation 0.29	2.50 log10 copies/mL Standard Deviation 0.00

PRIMARY outcome

Timeframe: Day 180

Population: 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.

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.

Outcome measures

Measure	Placebo n=32 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=35 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=32 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180	2.68 log10 copies/mL Standard Deviation 0.95	2.52 log10 copies/mL Standard Deviation 0.09	2.50 log10 copies/mL Standard Deviation 0.00

PRIMARY outcome

Timeframe: Day 0

Population: 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.

Motavizumab concentration in nasal wash aspirates is reported.

Outcome measures

Measure	Placebo n=38 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Motavizumab Concentration in Nasal Wash Aspirates at Day 0	0.93 ng/mL Standard Deviation 5.72	0.00 ng/mL Standard Deviation 0.00	—

PRIMARY outcome

Timeframe: Day 1

Population: 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.

Motavizumab concentration in nasal wash aspirates is reported.

Outcome measures

Measure	Placebo n=38 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Motavizumab Concentration in Nasal Wash Aspirates at Day 1	4673.3 ng/mL Standard Deviation 5397.4	10087 ng/mL Standard Deviation 10242	—

PRIMARY outcome

Timeframe: Day 2

Population: 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.

Motavizumab concentration in nasal wash aspirates is reported.

Outcome measures

Measure	Placebo n=38 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Motavizumab Concentration in Nasal Wash Aspirates at Day 2	2341.2 ng/mL Standard Deviation 2928.4	7436.7 ng/mL Standard Deviation 10321	—

PRIMARY outcome

Timeframe: Day 7

Population: 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.

Motavizumab concentration in nasal wash aspirates is reported.

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Motavizumab Concentration in Nasal Wash Aspirates at Day 7	966.37 ng/mL Standard Deviation 1016.0	2464.2 ng/mL Standard Deviation 2788.0	—

PRIMARY outcome

Timeframe: Day 30

Population: 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.

Motavizumab concentration in nasal wash aspirates is reported.

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=36 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Motavizumab Concentration in Nasal Wash Aspirates at Day 30	431.21 ng/mL Standard Deviation 597.6	1934.5 ng/mL Standard Deviation 3055.6	—

SECONDARY outcome

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

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

Duration of RSV hospitalization is reported.

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=39 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=36 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Duration of RSV Hospitalization	3.55 Days Standard Deviation 2.43	3.98 Days Standard Deviation 3.01	4.46 Days Standard Deviation 4.33

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=39 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=36 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Respiratory Assessment Change Score (RACS) Derived From Baseline Day 3	-4.29 Units on a score Standard Deviation 5.45	-5.49 Units on a score Standard Deviation 4.53	-5.41 Units on a score Standard Deviation 5.11
Respiratory Assessment Change Score (RACS) Derived From Baseline Day 7	-5.70 Units on a score Standard Deviation 5.40	-6.94 Units on a score Standard Deviation 4.89	-6.18 Units on a score Standard Deviation 5.23
Respiratory Assessment Change Score (RACS) Derived From Baseline Day 30	-6.00 Units on a score Standard Deviation 5.51	-7.14 Units on a score Standard Deviation 4.88	-7.79 Units on a score Standard Deviation 4.01
Respiratory Assessment Change Score (RACS) Derived From Baseline Day 1	-1.81 Units on a score Standard Deviation 5.05	-1.36 Units on a score Standard Deviation 4.47	-2.11 Units on a score Standard Deviation 4.58
Respiratory Assessment Change Score (RACS) Derived From Baseline Day 2	-2.14 Units on a score Standard Deviation 5.20	-3.51 Units on a score Standard Deviation 4.72	-3.61 Units on a score Standard Deviation 5.02

SECONDARY outcome

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

Population: 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.

Oxygen saturation level during RSV hospitalization is reported.

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=39 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=36 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Oxygen Saturation Level During RSV Hospitalization Day 30	97.9 Percentage of oxygen saturation Standard Deviation 1.7	98.1 Percentage of oxygen saturation Standard Deviation 1.8	98.5 Percentage of oxygen saturation Standard Deviation 1.3
Oxygen Saturation Level During RSV Hospitalization Day 0	96.8 Percentage of oxygen saturation Standard Deviation 2.5	97.5 Percentage of oxygen saturation Standard Deviation 1.9	97.1 Percentage of oxygen saturation Standard Deviation 3.1
Oxygen Saturation Level During RSV Hospitalization Day 1	97.3 Percentage of oxygen saturation Standard Deviation 2.3	98.1 Percentage of oxygen saturation Standard Deviation 1.6	97.2 Percentage of oxygen saturation Standard Deviation 2.1
Oxygen Saturation Level During RSV Hospitalization Day 2	96.9 Percentage of oxygen saturation Standard Deviation 2.4	97.3 Percentage of oxygen saturation Standard Deviation 2.1	97.5 Percentage of oxygen saturation Standard Deviation 2.0
Oxygen Saturation Level During RSV Hospitalization Day 3	97.7 Percentage of oxygen saturation Standard Deviation 1.8	97.6 Percentage of oxygen saturation Standard Deviation 1.7	97.4 Percentage of oxygen saturation Standard Deviation 2.3
Oxygen Saturation Level During RSV Hospitalization Day 7	97.6 Percentage of oxygen saturation Standard Deviation 1.9	97.8 Percentage of oxygen saturation Standard Deviation 1.4	97.6 Percentage of oxygen saturation Standard Deviation 2.3

SECONDARY outcome

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

Population: 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.

Heart rate during RSV hospitalization is reported.

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=39 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=36 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Heart Rate During RSV Hospitalization Day 0	148.6 Beats per minute Standard Deviation 17.8	155.6 Beats per minute Standard Deviation 19.5	157.6 Beats per minute Standard Deviation 17.0
Heart Rate During RSV Hospitalization Day 1	146.0 Beats per minute Standard Deviation 18.0	145.9 Beats per minute Standard Deviation 14.6	145.9 Beats per minute Standard Deviation 17.3
Heart Rate During RSV Hospitalization Day 2	141.2 Beats per minute Standard Deviation 11.9	139.6 Beats per minute Standard Deviation 15.1	136.6 Beats per minute Standard Deviation 17.3
Heart Rate During RSV Hospitalization Day 3	138.6 Beats per minute Standard Deviation 14.8	140.7 Beats per minute Standard Deviation 14.8	143.3 Beats per minute Standard Deviation 17.4
Heart Rate During RSV Hospitalization Day 7	139.6 Beats per minute Standard Deviation 14.8	141.4 Beats per minute Standard Deviation 20.2	143.5 Beats per minute Standard Deviation 15.9
Heart Rate During RSV Hospitalization Day 30	139.6 Beats per minute Standard Deviation 13.4	140.3 Beats per minute Standard Deviation 13.8	137.1 Beats per minute Standard Deviation 13.0

SECONDARY outcome

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

Population: 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.

Respiratory rate during RSV hospitalization is reported.

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=39 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=36 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Respiratory Rate During RSV Hospitalization Day 3	43.03 Breaths per minute Standard Deviation 9.28	40.54 Breaths per minute Standard Deviation 8.54	43.68 Breaths per minute Standard Deviation 10.81
Respiratory Rate During RSV Hospitalization Day 7	41.76 Breaths per minute Standard Deviation 9.06	40.14 Breaths per minute Standard Deviation 9.14	43.64 Breaths per minute Standard Deviation 11.06
Respiratory Rate During RSV Hospitalization Day 30	38.45 Breaths per minute Standard Deviation 6.73	41.11 Breaths per minute Standard Deviation 12.81	38.45 Breaths per minute Standard Deviation 6.53
Respiratory Rate During RSV Hospitalization Day 0	46.86 Breaths per minute Standard Deviation 10.20	49.28 Breaths per minute Standard Deviation 8.93	51.78 Breaths per minute Standard Deviation 11.28
Respiratory Rate During RSV Hospitalization Day 1	44.35 Breaths per minute Standard Deviation 11.88	48.67 Breaths per minute Standard Deviation 12.41	48.00 Breaths per minute Standard Deviation 14.13
Respiratory Rate During RSV Hospitalization Day 2	46.46 Breaths per minute Standard Deviation 9.05	41.89 Breaths per minute Standard Deviation 10.76	44.11 Breaths per minute Standard Deviation 11.77

SECONDARY outcome

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

Population: 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.

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

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=36 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Number of Participants With Supplemental Oxygen Use During RSV Hospitalization	24 Participants	30 Participants	29 Participants

SECONDARY outcome

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

Population: 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.

Duration of supplemental oxygen use during RSV hospitalization is reported.

Outcome measures

Measure	Placebo n=24 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=30 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=29 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Duration of Supplemental Oxygen Use During RSV Hospitalization	3.5 Days Standard Deviation 1.8	4.1 Days Standard Deviation 2.8	4.4 Days Standard Deviation 4.1

SECONDARY outcome

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

Population: 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.

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

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=36 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Number of Participants on Mechanical Ventilation During RSV Hospitalization	0 Participants	2 Participants	2 Participants

SECONDARY outcome

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

Population: 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.

Duration of mechanical ventilation during RSV hospitalization is reported.

Outcome measures

Measure	Placebo Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=2 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=2 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Duration of Mechanical Ventilation During RSV Hospitalization	—	7.81 Days Standard Deviation 0.88	4.64 Days Standard Deviation 2.30

SECONDARY outcome

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

Population: 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.

Number of participants admitted to ICU is reported.

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=36 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Number of Participants Admitted to the Intensive Care Unit (ICU)	0 Participants	3 Participants	3 Participants

SECONDARY outcome

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

Population: 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.

Duration of ICU stay during RSV hospitalization is reported.

Outcome measures

Measure	Placebo Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=3 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=3 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Duration of ICU Stay During RSV Hospitalization	—	7.3 Days Standard Deviation 4.6	5.0 Days Standard Deviation 4.0

SECONDARY outcome

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

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

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.

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=39 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=36 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Number of Participants With Medically-attended Wheezing Episodes 1 event	19 Participants	20 Participants	18 Participants
Number of Participants With Medically-attended Wheezing Episodes 3 events	1 Participants	4 Participants	4 Participants
Number of Participants With Medically-attended Wheezing Episodes 4 events	2 Participants	4 Participants	3 Participants
Number of Participants With Medically-attended Wheezing Episodes 5 events	2 Participants	3 Participants	2 Participants
Number of Participants With Medically-attended Wheezing Episodes 6 events	2 Participants	1 Participants	0 Participants
Number of Participants With Medically-attended Wheezing Episodes 7 events	0 Participants	0 Participants	0 Participants
Number of Participants With Medically-attended Wheezing Episodes 8 events	0 Participants	0 Participants	0 Participants
Number of Participants With Medically-attended Wheezing Episodes 9 events	0 Participants	1 Participants	0 Participants
Number of Participants With Medically-attended Wheezing Episodes 0 event	2 Participants	0 Participants	2 Participants
Number of Participants With Medically-attended Wheezing Episodes 2 events	9 Participants	6 Participants	7 Participants

SECONDARY outcome

Timeframe: Days 1, 7, 90, 180, and 360

Population: 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.

Motavizumab concentration in serum is reported.

Outcome measures

Measure	Placebo n=38 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Serum Concentration of Motavizumab Day 1	298.73 mcg/mL Standard Deviation 88.99	863.05 mcg/mL Standard Deviation 240.28	—
Serum Concentration of Motavizumab Day 360	0.04 mcg/mL Standard Deviation 0.26	0 mcg/mL Standard Deviation 0	—
Serum Concentration of Motavizumab Day 7	192.87 mcg/mL Standard Deviation 57.07	640.36 mcg/mL Standard Deviation 95.69	—
Serum Concentration of Motavizumab Day 90	11.39 mcg/mL Standard Deviation 9.35	30.81 mcg/mL Standard Deviation 23.63	—
Serum Concentration of Motavizumab Day 180	0.64 mcg/mL Standard Deviation 1.41	2.45 mcg/mL Standard Deviation 3.54	—

SECONDARY outcome

Timeframe: Days 0, 180, and 360

Population: 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.

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.

Outcome measures

Measure	Placebo n=38 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Number of Participants With Detectable Anti-motavizumab Antibodies Day 0	1 Participants	1 Participants	—
Number of Participants With Detectable Anti-motavizumab Antibodies Day 180	11 Participants	10 Participants	—
Number of Participants With Detectable Anti-motavizumab Antibodies Day 360	21 Participants	14 Participants	—

SECONDARY outcome

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

Population: 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.

Outcome measures

Measure	Placebo n=30 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=34 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=28 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Change From Baseline in Serum Cytokine Levels Interleukin-1(IL-1) beta: Day 360	-3.005 Picograms per millilitre (pg/mL) Standard Deviation 12.043	0.48 Picograms per millilitre (pg/mL) Standard Deviation 2.442	48.943 Picograms per millilitre (pg/mL) Standard Deviation 236.734
Change From Baseline in Serum Cytokine Levels IL-2: Day 360	-7.881 Picograms per millilitre (pg/mL) Standard Deviation 30.340	0.446 Picograms per millilitre (pg/mL) Standard Deviation 7.604	108.245 Picograms per millilitre (pg/mL) Standard Deviation 445.422
Change From Baseline in Serum Cytokine Levels Il-5: Day 360	1.045 Picograms per millilitre (pg/mL) Standard Deviation 4.661	0.763 Picograms per millilitre (pg/mL) Standard Deviation 1.817	0.774 Picograms per millilitre (pg/mL) Standard Deviation 8.296
Change From Baseline in Serum Cytokine Levels IL-6: Day 360	-41.180 Picograms per millilitre (pg/mL) Standard Deviation 72.120	-24.305 Picograms per millilitre (pg/mL) Standard Deviation 61.462	118.469 Picograms per millilitre (pg/mL) Standard Deviation 524.680
Change From Baseline in Serum Cytokine Levels IL-7: Day 360	-1.328 Picograms per millilitre (pg/mL) Standard Deviation 7.797	0.691 Picograms per millilitre (pg/mL) Standard Deviation 5.094	4.305 Picograms per millilitre (pg/mL) Standard Deviation 36.131
Change From Baseline in Serum Cytokine Levels IL-8: Day 360	-20.059 Picograms per millilitre (pg/mL) Standard Deviation 19.790	-18.323 Picograms per millilitre (pg/mL) Standard Deviation 25.204	-21.440 Picograms per millilitre (pg/mL) Standard Deviation 20.033
Change From Baseline in Serum Cytokine Levels IL12 P70: Day 360	-10.633 Picograms per millilitre (pg/mL) Standard Deviation 49.320	2.660 Picograms per millilitre (pg/mL) Standard Deviation 18.759	48.765 Picograms per millilitre (pg/mL) Standard Deviation 239.216
Change From Baseline in Serum Cytokine Levels IL13: Day 360	-0.779 Picograms per millilitre (pg/mL) Standard Deviation 8.086	1.744 Picograms per millilitre (pg/mL) Standard Deviation 3.244	9.893 Picograms per millilitre (pg/mL) Standard Deviation 54.188
Change From Baseline in Serum Cytokine Levels IL-15: Day 360	-4.999 Picograms per millilitre (pg/mL) Standard Deviation 14.377	-0.402 Picograms per millilitre (pg/mL) Standard Deviation 1.473	33.618 Picograms per millilitre (pg/mL) Standard Deviation 139.355
Change From Baseline in Serum Cytokine Levels IL-17: Day 360	2.067 Picograms per millilitre (pg/mL) Standard Deviation 16.207	8.056 Picograms per millilitre (pg/mL) Standard Deviation 24.954	1.092 Picograms per millilitre (pg/mL) Standard Deviation 22.159
Change From Baseline in Serum Cytokine Levels Eotaxin: Day 360	-8.790 Picograms per millilitre (pg/mL) Standard Deviation 138.692	36.955 Picograms per millilitre (pg/mL) Standard Deviation 118.098	202.122 Picograms per millilitre (pg/mL) Standard Deviation 728.741
Change From Baseline in Serum Cytokine Levels Basic fibroblast growth factor: Day (D) 360	1.886 Picograms per millilitre (pg/mL) Standard Deviation 34.663	-1.342 Picograms per millilitre (pg/mL) Standard Deviation 6.920	6.593 Picograms per millilitre (pg/mL) Standard Deviation 34.509
Change From Baseline in Serum Cytokine Levels Granulocyte-colony stimulating factor (G-CSF):D360	-98.351 Picograms per millilitre (pg/mL) Standard Deviation 192.339	-91.782 Picograms per millilitre (pg/mL) Standard Deviation 184.339	-42.870 Picograms per millilitre (pg/mL) Standard Deviation 108.678
Change From Baseline in Serum Cytokine Levels Granulocyte macrophage -CSF: Day 360	-54.862 Picograms per millilitre (pg/mL) Standard Deviation 185.534	-7.439 Picograms per millilitre (pg/mL) Standard Deviation 26.842	964.242 Picograms per millilitre (pg/mL) Standard Deviation 4386.145
Change From Baseline in Serum Cytokine Levels Interferon (IFN) gamma: Day 360	-65.424 Picograms per millilitre (pg/mL) Standard Deviation 258.871	9.164 Picograms per millilitre (pg/mL) Standard Deviation 91.580	464.277 Picograms per millilitre (pg/mL) Standard Deviation 2027.072
Change From Baseline in Serum Cytokine Levels IFN alpha: Day 360	-23.980 Picograms per millilitre (pg/mL) Standard Deviation 121.625	12.281 Picograms per millilitre (pg/mL) Standard Deviation 67.767	194.351 Picograms per millilitre (pg/mL) Standard Deviation 835.999
Change From Baseline in Serum Cytokine Levels IL-1 receptor antagonist (RA): Day 360	-266.925 Picograms per millilitre (pg/mL) Standard Deviation 502.650	-107.834 Picograms per millilitre (pg/mL) Standard Deviation 201.740	-171.278 Picograms per millilitre (pg/mL) Standard Deviation 599.988
Change From Baseline in Serum Cytokine Levels IL4: Day 360	-0.717 Picograms per millilitre (pg/mL) Standard Deviation 5.733	2.187 Picograms per millilitre (pg/mL) Standard Deviation 8.596	5.394 Picograms per millilitre (pg/mL) Standard Deviation 30.426
Change From Baseline in Serum Cytokine Levels IL-9: Day 360	58.378 Picograms per millilitre (pg/mL) Standard Deviation 308.184	-45.673 Picograms per millilitre (pg/mL) Standard Deviation 188.920	-48.034 Picograms per millilitre (pg/mL) Standard Deviation 204.545
Change From Baseline in Serum Cytokine Levels IL-10: Day 360	-11.407 Picograms per millilitre (pg/mL) Standard Deviation 21.458	-6.924 Picograms per millilitre (pg/mL) Standard Deviation 7.927	3.786 Picograms per millilitre (pg/mL) Standard Deviation 75.604
Change From Baseline in Serum Cytokine Levels IFN gamma induced protein 10 (IP-10): Day 360	-1089.184 Picograms per millilitre (pg/mL) Standard Deviation 1711.708	-1028.280 Picograms per millilitre (pg/mL) Standard Deviation 1105.987	-460.829 Picograms per millilitre (pg/mL) Standard Deviation 2216.789
Change From Baseline in Serum Cytokine Levels Monocyte chemoattractant protein-1: Day 360	-75.818 Picograms per millilitre (pg/mL) Standard Deviation 96.097	-52.910 Picograms per millilitre (pg/mL) Standard Deviation 84.827	17.128 Picograms per millilitre (pg/mL) Standard Deviation 376.408
Change From Baseline in Serum Cytokine Levels Macrophage inflammatory protein (MIP)-1 alpha:D360	0.604 Picograms per millilitre (pg/mL) Standard Deviation 7.309	0.689 Picograms per millilitre (pg/mL) Standard Deviation 2.485	-31.042 Picograms per millilitre (pg/mL) Standard Deviation 182.639
Change From Baseline in Serum Cytokine Levels MIP-1 beta: Day 360	-1.950 Picograms per millilitre (pg/mL) Standard Deviation 105.553	43.061 Picograms per millilitre (pg/mL) Standard Deviation 121.617	-1.354 Picograms per millilitre (pg/mL) Standard Deviation 235.052
Change From Baseline in Serum Cytokine Levels Platelet-derived growth factor (PDGF)-BB: Day 360	3461.665 Picograms per millilitre (pg/mL) Standard Deviation 5874.913	4377.256 Picograms per millilitre (pg/mL) Standard Deviation 6050.996	3631.464 Picograms per millilitre (pg/mL) Standard Deviation 9603.609
Change From Baseline in Serum Cytokine Levels Rantes: Day 360	783.389 Picograms per millilitre (pg/mL) Standard Deviation 2664.670	2946.934 Picograms per millilitre (pg/mL) Standard Deviation 8074.666	793.431 Picograms per millilitre (pg/mL) Standard Deviation 2672.889
Change From Baseline in Serum Cytokine Levels Tumor necrosis factor (TNF) alpha: Day 360	-17.112 Picograms per millilitre (pg/mL) Standard Deviation 62.119	-2.676 Picograms per millilitre (pg/mL) Standard Deviation 29.385	403.443 Picograms per millilitre (pg/mL) Standard Deviation 1918.152
Change From Baseline in Serum Cytokine Levels Vascular endothelial growth factor (VEGF): Day 360	-17.908 Picograms per millilitre (pg/mL) Standard Deviation 135.254	-33.293 Picograms per millilitre (pg/mL) Standard Deviation 125.224	-39.069 Picograms per millilitre (pg/mL) Standard Deviation 87.616
Change From Baseline in Serum Cytokine Levels Monokine induced by gamma(MIG): Day 360	1046.002 Picograms per millilitre (pg/mL) Standard Deviation 2735.420	1086.786 Picograms per millilitre (pg/mL) Standard Deviation 1246.951	2465.946 Picograms per millilitre (pg/mL) Standard Deviation 7714.076

SECONDARY outcome

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

Population: 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.

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

Outcome measures

Measure	Placebo n=32 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=35 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=32 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IL-1 beta: Day 180	-2607.852 pg/mL Standard Deviation 6378.263	-2575.906 pg/mL Standard Deviation 3423.519	-1772.376 pg/mL Standard Deviation 3150.626
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IL-1 RA: Day 180	-91761.764 pg/mL Standard Deviation 268797.553	-97050.821 pg/mL Standard Deviation 200487.750	-69391.250 pg/mL Standard Deviation 127840.986
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IL-2: Day 180	-0.849 pg/mL Standard Deviation 14.116	-1.215 pg/mL Standard Deviation 10.959	-0.458 pg/mL Standard Deviation 9.316
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IL-4: Day 180	-1.761 pg/mL Standard Deviation 3.090	-1.897 pg/mL Standard Deviation 2.939	-1.435 pg/mL Standard Deviation 3.571
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IL-5: Day 180	-0.077 pg/mL Standard Deviation 1.865	-0.351 pg/mL Standard Deviation 7.077	1.732 pg/mL Standard Deviation 7.974
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IL-6: Day 180	-1139.081 pg/mL Standard Deviation 1061.467	-930.388 pg/mL Standard Deviation 1730.515	-551.482 pg/mL Standard Deviation 676.661
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IL-7: Day 180	-6.553 pg/mL Standard Deviation 26.065	-20.954 pg/mL Standard Deviation 48.390	-18.219 pg/mL Standard Deviation 58.020
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IL-8: Day 180	-26762.935 pg/mL Standard Deviation 83539.520	-20794.797 pg/mL Standard Deviation 30409.576	-8610.260 pg/mL Standard Deviation 14715.271
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels MIP-1 alpha: Day 180	-81.063 pg/mL Standard Deviation 106.178	-79.610 pg/mL Standard Deviation 100.858	-54.416 pg/mL Standard Deviation 96.391
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels MIP-1 beta: Day 180	-924.715 pg/mL Standard Deviation 913.488	-921.287 pg/mL Standard Deviation 770.658	-824.330 pg/mL Standard Deviation 1063.855
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels PDGF-BB: Day 180	-95.616 pg/mL Standard Deviation 197.836	-90.821 pg/mL Standard Deviation 192.864	-55.547 pg/mL Standard Deviation 127.111
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels Rantes: Day 180	-244.749 pg/mL Standard Deviation 971.092	-789.419 pg/mL Standard Deviation 3136.828	-194.783 pg/mL Standard Deviation 493.671
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IL-9: Day 180	-32.899 pg/mL Standard Deviation 40.569	-48.923 pg/mL Standard Deviation 57.492	-45.623 pg/mL Standard Deviation 85.438
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels Il-10: Day 180	-55.412 pg/mL Standard Deviation 65.437	-65.522 pg/mL Standard Deviation 107.589	-37.755 pg/mL Standard Deviation 60.765
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IL-12 P70: Day 180	-52.927 pg/mL Standard Deviation 60.597	-54.300 pg/mL Standard Deviation 55.463	-40.912 pg/mL Standard Deviation 64.739
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IL-13: Day 180	-54.573 pg/mL Standard Deviation 151.800	-59.583 pg/mL Standard Deviation 116.696	-43.758 pg/mL Standard Deviation 93.016
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IL-15: Day 180	-4.018 pg/mL Standard Deviation 17.009	-7.107 pg/mL Standard Deviation 14.202	-5.039 pg/mL Standard Deviation 15.169
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IL-17: Day 180	-22.557 pg/mL Standard Deviation 27.252	-31.352 pg/mL Standard Deviation 25.301	-25.215 pg/mL Standard Deviation 36.297
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels Eotaxin: Day180	-16.905 pg/mL Standard Deviation 140.534	-42.034 pg/mL Standard Deviation 90.948	-23.358 pg/mL Standard Deviation 78.999
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels Basic FGF: Day 180	-82.364 pg/mL Standard Deviation 125.246	-149.153 pg/mL Standard Deviation 267.861	-117.656 pg/mL Standard Deviation 183.542
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels G-CSF:Day 180	-3547.084 pg/mL Standard Deviation 7428.810	-3732.054 pg/mL Standard Deviation 9873.369	-112.012 pg/mL Standard Deviation 9701.760
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels GM-CSF: Day 180	-86.359 pg/mL Standard Deviation 139.214	-79.592 pg/mL Standard Deviation 119.261	-79.668 pg/mL Standard Deviation 157.497
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IFN gamma: Day180	-5754.670 pg/mL Standard Deviation 27853.042	-3026.337 pg/mL Standard Deviation 13551.380	-2755.333 pg/mL Standard Deviation 15534.906
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IFN alpha: Day180	-59.346 pg/mL Standard Deviation 413.227	-95.529 pg/mL Standard Deviation 442.959	-15.090 pg/mL Standard Deviation 240.549
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels IP-10: Day 180	2907.151 pg/mL Standard Deviation 14396.032	-21562.675 pg/mL Standard Deviation 94358.228	-15729.066 pg/mL Standard Deviation 93210.658
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels MCP-1: Day 180	-510.596 pg/mL Standard Deviation 821.385	-336.373 pg/mL Standard Deviation 230.303	-317.251 pg/mL Standard Deviation 532.157
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels TNF alpha: Day 180	-1489.621 pg/mL Standard Deviation 3190.856	-1038.889 pg/mL Standard Deviation 1660.820	-610.185 pg/mL Standard Deviation 1129.565
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels VEGF: Day 180	-1167.204 pg/mL Standard Deviation 1698.618	-1118.459 pg/mL Standard Deviation 1365.524	-700.258 pg/mL Standard Deviation 1154.582
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels MIG: Day 180	-42371.446 pg/mL Standard Deviation 124818.988	-6693.146 pg/mL Standard Deviation 25633.807	-25881.359 pg/mL Standard Deviation 110834.744

SECONDARY outcome

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

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

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.

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Any TEAEs	33 Participants	28 Participants	32 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Any TESAEs	6 Participants	6 Participants	7 Participants

SECONDARY outcome

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

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

Outcome measures

Measure	Placebo n=37 Participants Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=38 Participants Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs Hypoalbuminaemia	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs Thrombocythaemia	1 Participants	0 Participants	1 Participants
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs Platelet count increased	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs Hypokalaemia	0 Participants	1 Participants	1 Participants
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs Hypercalcaemia	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs Hyperphosphatasaemia	1 Participants	0 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs Blood urea increased	0 Participants	0 Participants	1 Participants
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs Liver function test abnormal	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs Anaemia	1 Participants	3 Participants	1 Participants
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs Hyperkalaemia	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs Hypernatraemia	1 Participants	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 30 other events

Deaths: 0 deaths

Motavizumab 30 mg/kg

Serious events: 6 serious events

Other events: 22 other events

Deaths: 0 deaths

Motavizumab 100 mg/kg

Serious events: 7 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=37 participants at risk Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 participants at risk Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=38 participants at risk Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Gastrointestinal disorders Diarrhoea	2.7% 1/37 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/37 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
General disorders Pyrexia	0.00% 0/37 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/37 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Otitis media acute	2.7% 1/37 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Respiratory syncytial virus bronchiolitis	5.4% 2/37 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Sepsis	0.00% 0/37 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Injury, poisoning and procedural complications Concussion	0.00% 0/37 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Metabolism and nutrition disorders Hypernatraemia	2.7% 1/37 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/37 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/37 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Bronchiolitis	0.00% 0/37 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Bronchitis	0.00% 0/37 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Pneumonia	2.7% 1/37 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Pneumonia respiratory syncytial viral	2.7% 1/37 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/37 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Metabolism and nutrition disorders Metabolic acidosis	2.7% 1/37 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/37 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	5.3% 2/38 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/37 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.

Other adverse events

Measure	Placebo n=37 participants at risk Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Motavizumab 30 mg/kg n=38 participants at risk Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Motavizumab 100 mg/kg n=38 participants at risk Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
Blood and lymphatic system disorders Anaemia	2.7% 1/37 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	7.9% 3/38 • Number of events 3 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Eye disorders Conjunctivitis	8.1% 3/37 • Number of events 3 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	5.3% 2/38 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	7.9% 3/38 • Number of events 3 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/37 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	5.3% 2/38 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Gastrointestinal disorders Constipation	5.4% 2/37 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Gastrointestinal disorders Diarrhoea	5.4% 2/37 • Number of events 3 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	10.5% 4/38 • Number of events 4 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	7.9% 3/38 • Number of events 3 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Gastrointestinal disorders Vomiting	13.5% 5/37 • Number of events 6 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	10.5% 4/38 • Number of events 4 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	5.3% 2/38 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Bronchitis	24.3% 9/37 • Number of events 14 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	10.5% 4/38 • Number of events 6 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	13.2% 5/38 • Number of events 7 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Pneumonia	2.7% 1/37 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	5.3% 2/38 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	5.4% 2/37 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	7.9% 3/38 • Number of events 4 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	8.1% 3/37 • Number of events 3 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	5.3% 2/38 • Number of events 3 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.7% 1/37 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	5.3% 2/38 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
General disorders Pyrexia	27.0% 10/37 • Number of events 10 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	15.8% 6/38 • Number of events 7 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	15.8% 6/38 • Number of events 7 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Nasopharyngitis	5.4% 2/37 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	21.1% 8/38 • Number of events 10 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	10.5% 4/38 • Number of events 4 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Otitis media	10.8% 4/37 • Number of events 4 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	5.3% 2/38 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	10.5% 4/38 • Number of events 4 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Otitis media acute	2.7% 1/37 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	7.9% 3/38 • Number of events 4 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Pharyngitis	0.00% 0/37 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	5.3% 2/38 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Upper respiratory tract infection	16.2% 6/37 • Number of events 6 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	5.3% 2/38 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Infections and infestations Urinary tract infection	2.7% 1/37 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	5.3% 2/38 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.4% 2/37 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	7.9% 3/38 • Number of events 3 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	5.4% 2/37 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	2.6% 1/38 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis diaper	8.1% 3/37 • Number of events 3 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	5.3% 2/38 • Number of events 2 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	10.5% 4/38 • Number of events 4 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.
Skin and subcutaneous tissue disorders Rash	2.7% 1/37 • Number of events 1 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	0.00% 0/38 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.	7.9% 3/38 • Number of events 3 • From the start of study drug (Day 0) through Day 90 Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.

Additional Information

Global Clinical Lead

AstraZeneca Clinical study Information Center

Phone: +1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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 in 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.
• Publication restrictions are in place

Restriction type: OTHER