A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children with Respiratory Syncytial Virus (RSV) Illness

Study identifier:MI-CP146

ClinicalTrials.gov identifier:NCT00435227

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Single Intramuscular Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Outpatient Treatment of Children with RSV Illness

Medical condition

Participants less than 12 months of age with RSV illness

Phase

Phase 2

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

Study type

Interventional

Age

0 Months - 12 Months

Date

Study Start Date: 20 Mar 2007

Primary Completion Date: 31 May 2008

Study Completion Date: 31 May 2008

Study design

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

Verification:

Verified 01 Jul 2021 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Previously healthy
- Age ≤12 months at the time of randomization
- Weight ≤10 kg at the time of randomization
- Gestational age ≥36 weeks
- RSV illness (must have coryza) documented by a positive RSV test at the time of evaluation
- Documented stable clinical condition that does not require hospitalization (oxygen saturation ≥ 95%; respiratory rate < 60 breaths/minute in children < 2 months and < 50 breaths/minute in children 2-12 months)
- Respiratory Distress Assessment Instrument (RDAI) score of ≤ 6 (there can be no more than 1 point assigned for each of the 6 assessment categories) at baseline evaluation
- Randomization within 4 hours of being evaluated with a positive Binax® RSV test
- Written informed consent obtained from the participant's parent(s) or legal guardian

Exclusion Criteria

- Prior receipt of or receiving treatment with steroids (except topical steroids) prior to randomization
- Prior medically diagnosed RSV infection
- Prior receipt of or receiving anti-viral treatment for the current episode of RSV infection prior to randomization
- Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than the acute RSV infection
- Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
- Requirement for supplemental oxygen (brief use of oxygen in the immediate postnatal period to treat a transient condition is allowed)
- Mechanical ventilation at any time prior to the onset of the current RSV infection
- Congenital heart disease [children with medically or surgically closed patent ductus arteriosus (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed]
- Previous reaction to intravenous immunoglobulin (IVIG), blood products, or other foreign proteins
- Prior use of IVIG, RSV-IGIV (RespiGam®), motavizumab or other immunoglobulin products within the past 2 months
- Prior use of palivizumab (Synagis®) within the past 2 months
- Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
- Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV

Location

Research Site

Orange, CA, United States, 92868

Location

Research Site

Detroit, MI, United States, 48201

Location

Research Site

Augusta, GA, United States, 30912

Location

Research Site

Oklahoma City, OK, United States, 73104

Location

Research Site

Youngstown, OH, United States, 44051

Location

Research Site

Brooklyn, NY, United States, 11203-2098

Location

Research Site

Boston, MA, United States, 02111

Location

Research Site

Huntington, WV, United States, 25701-3655

Arms	Assigned Interventions
Experimental: Motavizumab Participants will receive a single IM dose of 30 mg/kg of motavizumab on Day 0 of the study.	Biological/Vaccine: Motavizumab A single IM dose of 30 mg/kg will be administered on Day 0 of the study. Other Name: MEDI-524
Placebo Comparator: Placebo Participants will receive a single IM dose of placebo matched to motavizumab on Day 0 of the study.	Other: Placebo A single IM dose of placebo matched to motavizumab will be administered on Day 0 of the study.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted from 20Mar2007 to 31May2008 in the United States of America.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 12 participants were randomized in the study.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Participant Flow: Overall Study

	Placebo	Motavizumab 30 mg
STARTED	5	7
COMPLETED	5	7
NOT COMPLETED	0	0

Baseline Characteristics

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

Intent-to-treat (ITT) population included all participants who were randomized.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Baseline Measures

	Placebo	Motavizumab 30 mg	Total
Number of Participants [units: Participants]	5	7	12
Age Continuous [units: Months] Mean ± Standard Deviation	3.78 ± 1.97	5.79 ± 3.68	4.95 ± 3.14
Sex: Female, Male [units: Participants]
Female	3	4	7
Male	2	3	5
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	0	1	1
Not Hispanic or Latino	5	6	11
Unknown or Not Reported	0	0	0
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	0	1
White	4	7	11
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Outcome Measures

1. Primary Outcome Measure: Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by Reverse Transcriptase-polymerase Chain Reaction (RT-PCR) at Day 0 [ Time Frame: Day 0 ]

Measure Type	Primary
Measure Name	Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by Reverse Transcriptase-polymerase Chain Reaction (RT-PCR) at Day 0
Measure Description	The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
Time Frame	Day 0
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population included all participants who were randomized in the study. Participants who were RSV-positive at Day 0 were analyzed for this outcome.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	5	5
Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by Reverse Transcriptase-polymerase Chain Reaction (RT-PCR) at Day 0 [units: log10 copies/mL] Mean (Standard Deviation)	5.877 (1.503)	6.657 (0.999)

No statistical analysis provided for Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by Reverse Transcriptase-polymerase Chain Reaction (RT-PCR) at Day 0

2. Primary Outcome Measure: RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 2 [ Time Frame: Day 2 ]

Measure Type	Primary
Measure Name	RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 2
Measure Description	The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
Time Frame	Day 2
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population included all participants who were randomized in the study. Participants who were RSV-positive at Day 2 were analyzed for this outcome.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	5	4
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 2 [units: log10 copies/mL] Mean (Standard Deviation)	5.070 (1.905)	5.854 (1.855)

No statistical analysis provided for RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 2

3. Primary Outcome Measure: RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 30 [ Time Frame: Day 30 ]

Measure Type	Primary
Measure Name	RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 30
Measure Description	The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
Time Frame	Day 30
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population included all participants who were randomized in the study. Participants who were RSV-positive at Day 30 were analyzed for this outcome.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	5	5
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 30 [units: log10 copies/mL] Mean (Standard Deviation)	2.500 (0.000)	2.640 (0.312)

No statistical analysis provided for RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 30

4. Primary Outcome Measure: RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 90 [ Time Frame: Day 90 ]

Measure Type	Primary
Measure Name	RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 90
Measure Description	The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
Time Frame	Day 90
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population included all participants who were randomized in the study. Participants who were RSV-positive at Day 90 were analyzed for this outcome.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	5	5
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 90 [units: log10 copies/mL] Mean (Standard Deviation)	2.500 (0.000)	2.500 (0.000)

No statistical analysis provided for RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 90

5. Secondary Outcome Measure: Percentage of participants Who Have Progression of RSV Illness That Requires Subsequent Hospitalization [ Time Frame: From Randomiation (Day 0) Up to Day 30 ]

Measure Type	Secondary
Measure Name	Percentage of participants Who Have Progression of RSV Illness That Requires Subsequent Hospitalization
Measure Description	The percentage of participants who have progression of RSV illness that requires subsequent hospitalization is reported. RSV illness symptomps included fever, coryza, cough, and parental opinion of return to normal health and activity.
Time Frame	From Randomiation (Day 0) Up to Day 30
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	5	5
Percentage of participants Who Have Progression of RSV Illness That Requires Subsequent Hospitalization [units: Percentage of participants]	0	0

No statistical analysis provided for Percentage of participants Who Have Progression of RSV Illness That Requires Subsequent Hospitalization

6. Secondary Outcome Measure: Respiratory Assessment Change Score (RACS) Derived From Baseline [ Time Frame: Baseline (Day 0); and Days 2, 7, and 30 ]

Measure Type	Secondary
Measure Name	Respiratory Assessment Change Score (RACS) Derived From Baseline
Measure Description	The RACS assesses changes in wheezing and retractions as measured by the 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. 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 respiratory rate. The RACS is calculated as arithmetic sum of RDAI score change and of the 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.
Time Frame	Baseline (Day 0); and Days 2, 7, and 30
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	5	5
Respiratory Assessment Change Score (RACS) Derived From Baseline [units: Units on a score] Mean (Standard Deviation)
Day 2	1.80 (4.09)	2.20 (5.81)
Day 7	-0.20 (4.82)	-2.00 (1.58)
Day 30	-1.40 (4.51)	-2.00 (4.18)

No statistical analysis provided for Respiratory Assessment Change Score (RACS) Derived From Baseline

7. Secondary Outcome Measure: Change From Baseline in Oxygen Saturation Level [ Time Frame: Baseline (Day 0), Days 2, 7, and 30 ]

Measure Type	Secondary
Measure Name	Change From Baseline in Oxygen Saturation Level
Measure Description	Change from baseline in oxygen saturation level is reported.
Time Frame	Baseline (Day 0), Days 2, 7, and 30
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	5	5
Change From Baseline in Oxygen Saturation Level [units: Percentage of oxygen saturation] Mean (Standard Deviation)
Day 2	1.00 (1.73)	-1.00 (1.58)
Day 7	1.20 (2.17)	0.60 (1.34)
Day 30	1.80 (1.48)	0.40 (1.52)

No statistical analysis provided for Change From Baseline in Oxygen Saturation Level

8. Secondary Outcome Measure: Change in RACS of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization [ Time Frame: Baseline (Day 0) to Day 30 ]

Measure Type	Secondary
Measure Name	Change in RACS of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization
Measure Description	The RACS assesses changes in wheezing and retractions as measured by the 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 <= 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 the arithmetic sum of the RDAI score change and of the 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 the RACS represents improvement, whereas an increase signifies deterioration.
Time Frame	Baseline (Day 0) to Day 30
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants required hospitalization.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	0	0
Change in RACS of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization [units: Units on a score] Mean (Standard Deviation)

No statistical analysis provided for Change in RACS of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization

9. Secondary Outcome Measure: Oxygen Saturation Levels in RSV-infected Outpatient Participants Who Subsequently Required Hospitalization [ Time Frame: Baseline (Day 0) to Day 30 ]

Measure Type	Secondary
Measure Name	Oxygen Saturation Levels in RSV-infected Outpatient Participants Who Subsequently Required Hospitalization
Measure Description
Time Frame	Baseline (Day 0) to Day 30
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants required hospitalization.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	0	0
Oxygen Saturation Levels in RSV-infected Outpatient Participants Who Subsequently Required Hospitalization [units: Percentage of oxygen saturation] Mean (Standard Deviation)

No statistical analysis provided for Oxygen Saturation Levels in RSV-infected Outpatient Participants Who Subsequently Required Hospitalization

10. Secondary Outcome Measure: Heart Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization [ Time Frame: Baseline (Day 0) to Day 30 ]

Measure Type	Secondary
Measure Name	Heart Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization
Measure Description
Time Frame	Baseline (Day 0) to Day 30
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants required hospitalization.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	0	0
Heart Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization [units: Beats per minute] Mean (Standard Deviation)

No statistical analysis provided for Heart Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization

11. Secondary Outcome Measure: Respiratory Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization [ Time Frame: Baseline (Day 0) to Day 30 ]

Measure Type	Secondary
Measure Name	Respiratory Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization
Measure Description
Time Frame	Baseline (Day 0) to Day 30
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants required hospitalization.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	0	0
Respiratory Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization [units: Breaths per minute] Mean (Standard Deviation)

No statistical analysis provided for Respiratory Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization

12. Secondary Outcome Measure: Number of participants who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical Ventilation [ Time Frame: Baseline (Day 0) to Day 90 ]

Measure Type	Secondary
Measure Name	Number of participants who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical Ventilation
Measure Description	Number of participants who required hospitalization, ICU stay, supplemental oxygen, and mechanical ventilation is reported.
Time Frame	Baseline (Day 0) to Day 90
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	5	5
Number of participants who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical Ventilation [units: Participants]
Hospitalization	0	0
Supplemental oxygen	0	0
Mechanical ventilation	0	0
ICU stay	0	0

No statistical analysis provided for Number of participants who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical Ventilation

13. Secondary Outcome Measure: Duration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation required [ Time Frame: Baseline (Day 0) to Day 90 ]

Measure Type	Secondary
Measure Name	Duration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation required
Measure Description
Time Frame	Baseline (Day 0) to Day 90
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants were hospitalized or received intensive care or supplemental oxygen, or mechanical ventilation.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	0	0
Duration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation required [units: Days] Mean (Standard Deviation)
Hospitalization	0 ()	0 ()
Supplemental oxygen	0 ()	0 ()
Mechanical ventilation	0 ()	0 ()
ICU stay	0 ()	0 ()

No statistical analysis provided for Duration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation required

14. Secondary Outcome Measure: Number of Participants Who Progresses from Upper Respiratory Tract Infection to Lower Respiratory Tract Infection (LRI) [ Time Frame: Baseline (Day 0) to Day 30 ]

Measure Type	Secondary
Measure Name	Number of Participants Who Progresses from Upper Respiratory Tract Infection to Lower Respiratory Tract Infection (LRI)
Measure Description	A LRI event is one that has a medical diagnosis of bronchiolitis or pneumonia. In the absence of such a medical diagnosis, the occurrence of LRI events will be determined by the principal investigator after review of the medical record and based on the presence of retractions or lower respiratory tract rhonchi, wheezing, crackles, or rales in children with a positive RSV test.
Time Frame	Baseline (Day 0) to Day 30
Safety Issue?	Yes

Population Description

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

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	5	7
Number of Participants Who Progresses from Upper Respiratory Tract Infection to Lower Respiratory Tract Infection (LRI) [units: Participants]	0	1

No statistical analysis provided for Number of Participants Who Progresses from Upper Respiratory Tract Infection to Lower Respiratory Tract Infection (LRI)

15. Secondary Outcome Measure: Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications [ Time Frame: Baseline (Day 0) to Day 30 ]

Measure Type	Secondary
Measure Name	Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications
Measure Description	Number of LRI infected participants who required hospitalization, ICU stay, supplemental oxygen, mechanical ventilation, and respiratory medications are reported.
Time Frame	Baseline (Day 0) to Day 30
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population included all participants who had received any study drug and had any follow-up. Participants with LRI were analyzed for this outcome.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	0	1
Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications [units: Participants]
Hospitalization	0	0
Supplemental oxygen	0	0
Mechanical ventilation	0	0
ICU stay	0	0
Respiratory medication	0	0

No statistical analysis provided for Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications

16. Secondary Outcome Measure: RACS in Participants with LRI [ Time Frame: From Baseline (Day 0) to Days 2, 7, and 30 ]

Measure Type	Secondary
Measure Name	RACS in Participants with LRI
Measure Description	The RACS assesses changes in wheezing and retractions as measured by RDAI score and changes in respiratory rate. A RDAI score is a measure of 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 <= 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 the arithmetic sum of the RDAI score change and of the 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 the RACS represents improvement, whereas an increase signifies deterioration. RACS in participants with LRI is reported.
Time Frame	From Baseline (Day 0) to Days 2, 7, and 30
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population included all participants who had received any study drug and had any follow-up. Participants with LRI were analyzed for this outcome.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	0	1
RACS in Participants with LRI [units: Units on a score] Mean (Standard Deviation)
Day 2		12 (NA)^[1]
Day 7		-4 (NA)^[1]
Day 30		-1 (NA)^[1]

No statistical analysis provided for RACS in Participants with LRI

17. Secondary Outcome Measure: Motavizumab Concentration in Upper Respiratory Tract [ Time Frame: Days 0 (pre-dose), 2, and 30 ]

Measure Type	Secondary
Measure Name	Motavizumab Concentration in Upper Respiratory Tract
Measure Description	Motavizumab concentration in upper respiratory tract (nasal wash aspirates) is reported.
Time Frame	Days 0 (pre-dose), 2, and 30
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population for pharmacokinetic (PK) included all participants who have received a full dose of study drug.

Reporting Groups

	Description
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	7
Motavizumab Concentration in Upper Respiratory Tract [units: ng/mL] Mean (Standard Deviation)
Day 0	NA (NA)^[1]
Day 2	1216.186 (1828.934)
Day 30	348.256 (507.979)

No statistical analysis provided for Motavizumab Concentration in Upper Respiratory Tract

18. Secondary Outcome Measure: Serum Concentration of Motavizumab [ Time Frame: Days 2, 30, and 90 ]

Measure Type	Secondary
Measure Name	Serum Concentration of Motavizumab
Measure Description	Serum concentration of motavizumab is reported.
Time Frame	Days 2, 30, and 90
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population for PK included all participants who have received a full dose of study drug.

Reporting Groups

	Description
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	7
Serum Concentration of Motavizumab [units: mcg/mL] Mean (Standard Deviation)
Day 2	216.761 (43.867)
Day 30	126.296 (25.013)
Day 90	23.799 (9.810)

No statistical analysis provided for Serum Concentration of Motavizumab

19. Secondary Outcome Measure: Numbers of Participants With Positive Anti-Motavizumab Antibodies [ Time Frame: Days 0 (pre-dose) and 90 ]

Measure Type	Secondary
Measure Name	Numbers of Participants With Positive Anti-Motavizumab Antibodies
Measure Description	The number of participants with positive serum antibodies to motavizumab are reported.
Time Frame	Days 0 (pre-dose) and 90
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population for ADA included all participants who have received a full dose of study drug. Participants with adequate ADA samples were analysed for this outcome measure.

Reporting Groups

	Description
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	7
Numbers of Participants With Positive Anti-Motavizumab Antibodies [units: Participants]
Day 0	0
Day 90	0

No statistical analysis provided for Numbers of Participants With Positive Anti-Motavizumab Antibodies

20. Secondary Outcome Measure: Serum Cytokine Levels [ Time Frame: Days 0 (pre-dose), 30, and 90 ]

Measure Type	Secondary
Measure Name	Serum Cytokine Levels
Measure Description	Serum Cytokine Levels are reported.
Time Frame	Days 0 (pre-dose), 30, and 90
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Participants with adequate cytokine levels at specified time points were analyzed for this outcome.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	5	5
Serum Cytokine Levels [units: Picograms per millilitre (pg/mL)] Mean (Standard Deviation)
Interleukin 1 (IL-1) beta: Day 0	8.000 (0.000)	8.000 (0.000)
IL-1 beta: Day 30	8.000 (0.000)	8.000 (0.000)
IL-1 beta: Day 90	8.000 (0.000)	8.000 (0.000)
IL-1 receptor antagonist (RA): Day 0	8.000 (0.000)	8.000 (0.000)
IL-1 RA: Day 30	8.000 (0.000)	8.000 (0.000)
IL-1 RA: Day 90	11.000 (6.000)	10.960 (6.619)
IL-2: Day 0	8.000 (0.000)	8.000 (0.000)
IL-2: Day 30	8.000 (0.000)	8.000 (0.000)
IL-2: Day 90	8.000 (0.000)	8.000 (0.000)
IL-4: Day 0	8.000 (0.000)	8.000 (0.000)
IL-4: Day 30	8.000 (0.000)	8.000 (0.000)
IL-4: Day 90	10.900 (5.800)	13.060 (11.315)
IL-5: Day 0	1.600 (0.000)	1.600 (0.000)
IL-5: Day 30	1.600 (0.000)	1.600 (0.000)
IL-5: Day 90	19.925 (35.460)	3.080 (3.309)
IL-6: Day 0	2.620 (2.281)	12.025 (8.247)
IL-6: Day 30	1.600 (0.000)	1.980 (0.850)
IL-6: Day 90	22.950 (16.093)	4.040 (3.335)
IL-7: Day 0	8.000 (0.000)	8.000 (0.000)
IL-7: Day 30	8.000 (0.000)	8.000 (0.000)
IL-7: Day 90	8.000 (0.000)	8.000 (0.000)
IL-8: Day 0	28.500 (1.728)	28.525 (14.061)
IL-8: Day 30	12.900 (4.678)	7.900 (2.904)
IL-8: Day 90	38.475 (43.752)	12.120 (4.727)
IL-9: Day 0	1.600 (0.000)	1.600 (0.000)
IL-9: Day 30	1.600 (0.000)	3.020 (3.175)
IL-9: Day 90	7.925 (6.758)	4.200 (4.591)
IL-10: Day 0	36.400 (28.205)	29.625 (31.852)
IL-10: Day 30	19.325 (13.297)	8.000 (0.000)
IL-10: Day 90	13.900 (7.161)	8.000 (0.000)
IL-11: Day 0	13.133 (5.860)	9.750 (NA)^[1]
IL-11: Day 30	15.600 (10.132)	27.000 (29.878)
IL-11: Day 90	148.483 (143.545)	38.783 (32.632)
IL-12 P70: Day 0	8.000 (0.000)	8.000 (0.000)
IL-12 P70: Day 30	8.000 (0.000)	8.000 (0.000)
IL-12 P70: Day 90	20.450 (24.900)	8.000 (0.000)
IL-13: Day 0	8.000 (0.000)	8.000 (0.000)
IL-13: Day 30	8.000 (0.000)	8.000 (0.000)
IL-13: Day 90	8.000 (0.000)	11.060 (6.842)
IL-15: Day 0	1.600 (0.000)	1.600 (0.000)
IL-15: Day 30	1.600 (0.000)	1.600 (0.000)
IL-15: Day 90	2.100 (1.000)	1.600 (0.000)
IL-17: Day 0	2.160 (1.252)	1.600 (0.000)
IL-17: Day 30	2.675 (2.150)	1.600 (0.000)
IL-17: Day 90	29.875 (37.289)	5.180 (6.324)
Eotaxin: Day 0	120.860 (53.095)	116.325 (15.866)
Eotaxin: Day 30	117.500 (54.553)	105.720 (19.212)
Eotaxin: Day 90	139.275 (32.062)	87.960 (29.430)
Interferon (IFN) gamma: Day 0	16.020 (10.991)	8.000 (0.000)
IFN gamma: Day 30	8.000 (0.000)	8.000 (0.000)
IFN gamma: Day 90	115.675 (125.181)	14.740 (10.698)
IFN alpha 2: Day 0	8.000 (0.000)	12.000 (8.000)
IFN alpha 2: Day 30	8.000 (0.000)	12.060 (9.078)
IFN alpha 2: Day 90	20.175 (24.350)	12.220 (5.792)
IFN gamma induced protein (IP)-10: Day 0	605.740 (299.105)	723.950 (442.489)
IP-10: Day 30	518.775 (617.131)	136.360 (59.356)
IP-10: Day 90	310.150 (154.371)	287.000 (58.101)
Monocyte Chemoattractant Protein-1 (MCP-1): Day 0	729.860 (248.023)	717.850 (585.336)
MCP-1: Day 30	728.225 (245.660)	727.620 (635.702)
MCP-1: Day 90	596.125 (154.409)	542.320 (294.697)
Macrophage inflammatory protein (MIP)-1 alpha:Day0	8.000 (0.000)	8.000 (0.000)
MIP-1 alpha:Day 30	10.000 (4.000)	8.000 (0.000)
MIP-1 alpha: Day 90	25.375 (15.504)	8.000 (0.000)
MIP-1 beta: Day 0	99.560 (40.959)	70.150 (40.912)
MIP-1 beta: Day 30	92.513 (52.444)	95.700 (58.140)
MIP-1 beta: Day 90	117.300 (43.226)	77.780 (39.844)
Rantes: Day 0	23103.400 (10200.333)	35348.767 (11488.336)
Rantes: Day 30	26038.788 (3942.021)	29950.000 (13143.128)
Rantes: Day 90	41813.725 (45065.022)	30770.200 (15335.152)
TNF alpha: Day 0	25.320 (9.373)	23.075 (4.802)
TNF alpha: Day 30	21.925 (7.509)	21.200 (5.482)
TNF alpha: Day 90	21.925 (6.879)	21.040 (6.474)
Soluble IL-2 receptor (SIL-2R) alpha: Day 0	116.500 (81.702)	165.425 (78.977)
sIL-2R alpha: Day 30	117.988 (93.112)	108.060 (49.831)
SIL-2R alpha: Day 90	72.325 (12.848)	84.060 (48.465)

No statistical analysis provided for Serum Cytokine Levels

21. Secondary Outcome Measure: Nasal Wash Cytokine Levels [ Time Frame: Days 0 (pre-dose), 2, 30, and 90 ]

Measure Type	Secondary
Measure Name	Nasal Wash Cytokine Levels
Measure Description	Nasal wash cytokine levels are reported.
Time Frame	Days 0 (pre-dose), 2, 30, and 90
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Participants with adequate nasal wash cytokine levels at specified time points were analyzed for this outcome.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	5	5
Nasal Wash Cytokine Levels [units: pg/mL] Mean (Standard Deviation)
IL-1 beta: Day 0	79.380 (164.902)	282.380 (355.694)
IL-1 beta: Day 2	94.050 (123.565)	144.367 (113.883)
IL-1 beta: Day 30	10.520 (19.946)	156.240 (336.673)
IL-1 beta: Day 90	4.300 (4.391)	2.680 (2.415)
IL-1 RA: Day 0	79.200 (88.851)	205.040 (249.143)
IL-1 RA: Day 2	69.225 (50.434)	255.533 (184.664)
IL-1 RA: Day 30	38.460 (68.111)	94.600 (123.754)
IL-1 RA: Day 90	24.100 (22.976)	39.240 (30.922)
IL-2: Day 0	8.000 (0.000)	8.000 (0.000)
IL-2: Day 2	8.000 (0.000)	8.000 (0.000)
IL-2: Day 30	8.000 (0.000)	8.000 (0.000)
IL-4: Day 0	25.820 (34.379)	14.160 (13.774)
IL-4: Day 2	8.000 (0.000)	22.300 (17.419)
IL-4: Day 30	8.000 (0.000)	8.000 (0.000)
IL-4: Day 90	36.120 (29.029)	8.000 (0.000)
IL-5: Day 0	1.600 (0.000)	1.600 (0.000)
IL-5: Day 2	1.600 (0.000)	1.600 (0.000)
IL-5: Day30	1.600 (0.000)	1.600 (0.000)
IL-5: Day 90	1.600 (0.000)	1.600 (0.000)
IL-6: Day 0	172.480 (327.548)	411.320 (477.909)
IL-6: Day 2	42.950 (28.197)	278.467 (231.477)
IL-6: Day 30	3.300 (3.801)	19.440 (21.978)
IL-6: Day 90	6.540 (7.079)	7.300 (6.300)
IL-7: Day 0	15.220 (7.083)	19.480 (12.696)
IL-7: Day 2	15.700 (8.895)	30.567 (10.058)
IL-7: Day 30	8.000 (0.000)	8.000 (0.000)
IL-7: Day 90	13.460 (7.537)	11.620 (8.095)
IL-8: Day 0	701.600 (746.108)	1488.540 (791.215)
IL-8: Day 2	1347.975 (760.276)	2000.000 (0.000)
IL-8: Day 30	424.040 (881.148)	942.360 (976.506)
IL-8: Day 90	126.260 (151.768)	312.760 (269.980)
IL-9: Day 0	1.600 (0.000)	1.920 (0.716)
IL-9: Day 2	2.525 (1.850)	4.400 (3.208)
IL-9: Day 30	1.600 (0.000)	1.600 (0.000)
IL-9: Day 90	1.600 (0.000)	1.600 (0.000)
IL-10: Day 0	54.660 (94.235)	36.840 (31.400)
IL-10: Day 2	34.650 (55.865)	115.867 (123.508)
IL-10 Day 30	3.180 (3.533)	15.340 (20.013)
IL-10: Day 90	4.700 (4.699)	2.820 (2.728)
IL-11: Day 0	9.750 (0.000)	9.750 (0.000)
IL-11: Day 2	9.750 (0.000)	9.750 (0.000)
IL-11: Day 30	9.750 (0.000)	9.750 (0.000)
IL-11: Day 90	9.750 (0.000)	9.750 (0.000)
IL-12 P70: Day 0	11.380 (7.558)	10.240 (5.009)
IL-12 P70: Day 2	8.000 (0.000)	10.967 (5.138)
IL-12 P70: Day 30	8.000 (0.000)	8.000 (0.000)
IL-12 P70: Day 90	8.000 (0.000)	8.000 (0.000)
IL-13: Day 0	8.000 (0.000)	8.000 (0.000)
IL-13: Day 2	8.000 (0.000)	11.033 (5.254)
IL-13: Day 30	8.000 (0.000)	8.000 (0.000)
IL-13: Day 90	8.000 (0.000)	8.000 (0.000)
IL-15: Day 0	2.900 (2.907)	6.580 (4.089)
IL-15: Day 2	3.275 (2.311)	7.900 (1.418)
IL-15: Day 30	1.600 (0.000)	2.580 (1.470)
IL-15: Day 90	1.960 (0.805)	2.300 (1.565)
IL-17: Day 0	2.640 (2.326)	3.060 (2.024)
IL-17: Day 2	2.475 (1.750)	2.900 (2.252)
IL-17: Day 30	1.600 (0.000)	1.600 (0.000)
IL-17: Day 90	1.980 (0.850)	1.600 (0.000)
Eotaxin: Day 0	14.500 (10.201)	20.620 (8.461)
Eotaxin: Day 2	17.625 (11.507)	29.300 (7.758)
Eotaxin: Day 30	10.280 (5.098)	15.420 (11.445)
Eotaxin: Day 90	10.940 (6.574)	10.540 (5.680)
IFN gamma: Day 0	6.740 (11.493)	5.760 (2.788)
IFN gamma: Day 2	4.750 (5.170)	9.433 (4.140)
IFN gamma: Day 30	1.600 (0.000)	1.600 (0.000)
IFN gamma: Day 90	1.940 (0.760)	2.080 (1.073)
IFN alpha 2: Day 0	11.580 (8.005)	16.900 (8.306)
IFN alpha 2: Day 2	12.075 (8.150)	19.800 (11.377)
IFN alpha 2: Day 30	8.000 (0.000)	8.000 (0.000)
IFN alpha 2: Day 90	11.480 (4.774)	11.220 (7.200)
IP-10: Day 0	3030.820 (3653.453)	5850.060 (4510.860)
IP-10: Day 2	2699.550 (3369.371)	4405.733 (4604.409)
IP-10: Day 30	40.000 (0.000)	1378.140 (1435.513)
IP-10: Day 90	148.980 (90.285)	344.720 (201.758)
MCP-1: Day 0	138.280 (261.810)	352.860 (400.479)
MCP-1: Day 2	67.950 (72.134)	204.000 (239.883)
MCP-1: Day 30	15.160 (16.010)	75.900 (69.833)
MCP-1: Day 90	13.580 (7.651)	30.580 (21.161)
MIP-1 alpha: Day 0	229.060 (463.273)	116.280 (109.432)
MIP-1 alpha: Day 2	96.875 (102.773)	63.300 (57.022)
MIP-1 alpha: Day 30	34.720 (59.748)	83.880 (118.987)
MIP-1 alpha: Day 90	15.420 (16.592)	8.000 (0.000)
MIP-1 beta: Day 0	113.840 (211.563)	88.340 (91.090)
MIP-1 beta: Day 2	74.850 (53.517)	54.467 (30.928)
MIP-1 beta: Day 30	18.480 (23.434)	47.700 (71.854)
MIP-1 beta: Day 90	14.560 (14.669)	10.480 (5.545)
Rantes: Day 0	197.860 (404.890)	56.720 (72.686)
Rantes: Day 2	23.400 (15.609)	90.067 (116.383)
Rantes: Day 30	1.600 (0.000)	60.560 (97.653)
Rantes: Day 90	4.260 (3.717)	5.140 (5.594)
TNF alpha: Day 0	104.180 (222.984)	133.220 (122.334)
TNF alpha: Day 2	29.425 (30.522)	44.133 (34.563)
TNF alpha: Day 30	3.440 (4.114)	22.340 (32.064)
TNF alpha: Day 90	3.980 (5.322)	2.020 (0.939)
SIL-2R alpha: Day 0	10.500 (5.590)	14.580 (9.265)
SIL-2R alpha: Day 2	10.000 (4.000)	13.167 (8.949)
SIL-2R alpha: Day 30	8.000 (0.000)	8.000 (0.000)
SIL-2R alpha: Day 90	8.000 (0.000)	8.000 (0.000)
IL-2: Day 90	8.000 (0.000)	8.000 (0.000)

No statistical analysis provided for Nasal Wash Cytokine Levels

22. Secondary Outcome Measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [ Time Frame: From the administration of study drug (Day 0) through Day 90 ]

Measure Type	Secondary
Measure Name	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Measure Description	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.
Time Frame	From the administration of study drug (Day 0) through Day 90
Safety Issue?	Yes

Population Description

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

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Measured Values

	Placebo	Motavizumab 30 mg
Number of Participants Analyzed [units:participants]	5	7
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [units: Participants]
TEAEs	5	6
TESAEs	2	0

No statistical analysis provided for Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Serious Adverse Events

Time Frame	From the administration of study drug (Day 0) through Day 90
Additional Description	No text entered.

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Serious Adverse Events

Placebo

Motavizumab 30 mg

Total, serious adverse events

# participants affected / at risk

2/5 (40.00%)

0/7 (0.00%)

Infections and infestations

Gastroenteritis¹,^†

# participants affected / at risk

1/5 (20.00%)

0/7 (0.00%)

# events

Metabolism and nutrition disorders

Failure to thrive¹,^†

# participants affected / at risk

1/5 (20.00%)

0/7 (0.00%)

# events

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

Other Adverse Events

Time Frame	From the administration of study drug (Day 0) through Day 90
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Placebo	Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg	Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.

Other Adverse Events

Placebo

Motavizumab 30 mg

Total, other (not including serious) adverse events

# participants affected / at risk

5/5 (100.00%)

6/7 (85.71%)

Eye disorders

Conjunctivitis¹,^†

# participants affected / at risk

3/5 (60.00%)

0/7 (0.00%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

1/5 (20.00%)

0/7 (0.00%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

1/5 (20.00%)

0/7 (0.00%)

# events

Gastrointestinal disorders

Gastrooesophageal reflux disease¹,^†

# participants affected / at risk

1/5 (20.00%)

0/7 (0.00%)

# events

Gastrointestinal disorders

Lip blister¹,^†

# participants affected / at risk

0/5 (0.00%)

1/7 (14.29%)

# events

Gastrointestinal disorders

Teething¹,^†

# participants affected / at risk

1/5 (20.00%)

3/7 (42.86%)

# events

General disorders and administration site conditions

Irritability¹,^†

# participants affected / at risk

1/5 (20.00%)

0/7 (0.00%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

2/5 (40.00%)

1/7 (14.29%)

# events

Infections and infestations

Bronchiolitis¹,^†

# participants affected / at risk

0/5 (0.00%)

1/7 (14.29%)

# events

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

1/5 (20.00%)

0/7 (0.00%)

# events

Infections and infestations

Candidiasis¹,^†

# participants affected / at risk

1/5 (20.00%)

0/7 (0.00%)

# events

Infections and infestations

Gastroenteritis¹,^†

# participants affected / at risk

1/5 (20.00%)

0/7 (0.00%)

# events

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

1/5 (20.00%)

0/7 (0.00%)

# events

Infections and infestations

Otitis media¹,^†

# participants affected / at risk

3/5 (60.00%)

3/7 (42.86%)

# events

Infections and infestations

Respiratory syncytial virus bronchiolitis¹,^†

# participants affected / at risk

0/5 (0.00%)

1/7 (14.29%)

# events

Infections and infestations

Rhinitis¹,^†

# participants affected / at risk

1/5 (20.00%)

1/7 (14.29%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

2/5 (40.00%)

2/7 (28.57%)

# events

Infections and infestations

Viral skin infection¹,^†

# participants affected / at risk

1/5 (20.00%)

0/7 (0.00%)

# events

Infections and infestations

Viral upper respiratory tract infection¹,^†

# participants affected / at risk

0/5 (0.00%)

1/7 (14.29%)

# events

Injury, poisoning and procedural complications

Arthropod bite¹,^†

# participants affected / at risk

0/5 (0.00%)

1/7 (14.29%)

# events

Metabolism and nutrition disorders

Feeding disorder of infancy or early childhood¹,^†

# participants affected / at risk

1/5 (20.00%)

0/7 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Asthma¹,^†

# participants affected / at risk

1/5 (20.00%)

0/7 (0.00%)

# events

Skin and subcutaneous tissue disorders

Dermatitis contact¹,^†

# participants affected / at risk

0/5 (0.00%)

1/7 (14.29%)

# events

Skin and subcutaneous tissue disorders

Dermatitis diaper¹,^†

# participants affected / at risk

1/5 (20.00%)

2/7 (28.57%)

# events

Skin and subcutaneous tissue disorders

Heat rash¹,^†

# participants affected / at risk

0/5 (0.00%)

1/7 (14.29%)

# events

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

0/5 (0.00%)

1/7 (14.29%)

# events

Skin and subcutaneous tissue disorders

Rash papular¹,^†

# participants affected / at risk

1/5 (20.00%)

0/7 (0.00%)

# events

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

Certain Agreements

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

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

The agreement is:

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

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
On 21Feb2008, the study was terminated earlier than planned completion time due to an inability to enroll planned number of participants. Due to low enrollment, the data for outcome measure of "Duration of symptoms of RSV illness" was not collected.

Results Point of Contact

Name/Title:	Global Clinical Lead
Organization:	AstraZeneca Clinical study Information Center
Phone	1-877-240-9479
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

Kristin Kopasz

301-398-0000

clinicaltrialenquiries@medimmune.com

Contact Backup

Joseph Coffie

301-398-0000

clinicaltrialenquiries@medimmune.com

Investigators

Principal Investigator

M. Pamela Griffin

MedImmune Inc.

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Trial Results Summaries