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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00435227
Enrollment
12
Registered
2007-02-14
Start date
2007-03-20
Completion date
2008-05-31
Last updated
2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participants Less Than 12 Months of Age With RSV Illness

Keywords

Respiratory Syncytial Viruses, RSV

Brief summary

This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral load and motavizumab levels in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Using 1:1 randomization, 30 mg/kg motavizumab or placebo will be administered as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study has been confirmed.

Detailed description

This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg IM dose of motavizumab on viral load in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Participants were randomly assigned in a 1:1 ratio to 30 mg/kg motavizumab or placebo as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study had been confirmed. Randomization was stratified by age (\<6 months and greater than or equal to 6 to less than or equal to 12 months of age) and by site. Enrollment of an initial 100 children (50 per treatment group) will take place at multiple sites beginning in the 2006-2007 RSV season. The study was terminated early due to inability to enroll the planned number of participants.

Interventions

BIOLOGICALMotavizumab

A single IM dose of 30 mg/kg will be administered on Day 0 of the study.

OTHERPlacebo

A single IM dose of placebo matched to motavizumab will be administered on Day 0 of the study.

Sponsors

MedImmune LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
0 Months to 12 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 0Day 0The 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.
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 2Day 2The 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.
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 30Day 30The 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.
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 90Day 90The 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.

Secondary

MeasureTime frameDescription
Oxygen Saturation Levels in RSV-infected Outpatient Participants Who Subsequently Required HospitalizationBaseline (Day 0) to Day 30—
Heart Rate of RSV-infected Outpatient Participants Who Subsequently Required HospitalizationBaseline (Day 0) to Day 30—
Respiratory Rate of RSV-infected Outpatient Participants Who Subsequently Required HospitalizationBaseline (Day 0) to Day 30—
Number of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical VentilationBaseline (Day 0) to Day 90Number of participants who required hospitalization, ICU stay, supplemental oxygen, and mechanical ventilation is reported.
Duration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation RequiredBaseline (Day 0) to Day 90—
Number of Participants Who Progresses From Upper Respiratory Tract Infection to Lower Respiratory Tract Infection (LRI)Baseline (Day 0) to Day 30A 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.
Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory MedicationsBaseline (Day 0) to Day 30Number of LRI infected participants who required hospitalization, ICU stay, supplemental oxygen, mechanical ventilation, and respiratory medications are reported.
Percentage of Participants Who Have Progression of RSV Illness That Requires Subsequent HospitalizationFrom Randomiation (Day 0) Up to Day 30The 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.
Motavizumab Concentration in Upper Respiratory TractDays 0 (pre-dose), 2, and 30Motavizumab concentration in upper respiratory tract (nasal wash aspirates) is reported.
Serum Concentration of MotavizumabDays 2, 30, and 90Serum concentration of motavizumab is reported.
Numbers of Participants With Positive Anti-Motavizumab AntibodiesDays 0 (pre-dose) and 90The number of participants with positive serum antibodies to motavizumab are reported.
Serum Cytokine LevelsDays 0 (pre-dose), 30, and 90Serum Cytokine Levels are reported.
Nasal Wash Cytokine LevelsDays 0 (pre-dose), 2, 30, and 90Nasal wash cytokine levels are reported.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)From the administration of study drug (Day 0) through Day 90An 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.
RACS in Participants With LRIFrom Baseline (Day 0) to Days 2, 7, and 30The 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.
Respiratory Assessment Change Score (RACS) Derived From BaselineBaseline (Day 0); and Days 2, 7, and 30The 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.
Change From Baseline in Oxygen Saturation LevelBaseline (Day 0), Days 2, 7, and 30Change from baseline in oxygen saturation level is reported.
Change in RACS of RSV-infected Outpatient Participants Who Subsequently Required HospitalizationBaseline (Day 0) to Day 30The 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.

Countries

United States

Participant flow

Recruitment details

The study was conducted from 20Mar2007 to 31May2008 in the United States of America.

Pre-assignment details

A total of 12 participants were randomized in the study.

Participants by arm

ArmCount
Placebo
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
5
Motavizumab 30 mg
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
7
Total12

Baseline characteristics

CharacteristicMotavizumab 30 mgTotalPlacebo
Age, Continuous5.79 Months
STANDARD_DEVIATION 3.68
4.95 Months
STANDARD_DEVIATION 3.14
3.78 Months
STANDARD_DEVIATION 1.97
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants11 Participants5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
7 Participants11 Participants4 Participants
Sex: Female, Male
Female
4 Participants7 Participants3 Participants
Sex: Female, Male
Male
3 Participants5 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 50 / 7
other
Total, other adverse events
5 / 56 / 7
serious
Total, serious adverse events
2 / 50 / 7

Outcome results

Primary

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

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

Population: 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.

ArmMeasureValue (MEAN)Dispersion
PlaceboRespiratory 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 05.877 log10 copies/mLStandard Deviation 1.503
Motavizumab 30 mgRespiratory 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 06.657 log10 copies/mLStandard Deviation 0.999
Primary

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

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

Population: 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.

ArmMeasureValue (MEAN)Dispersion
PlaceboRSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 25.070 log10 copies/mLStandard Deviation 1.905
Motavizumab 30 mgRSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 25.854 log10 copies/mLStandard Deviation 1.855
Primary

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

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

Population: 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.

ArmMeasureValue (MEAN)Dispersion
PlaceboRSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 302.500 log10 copies/mLStandard Deviation 0
Motavizumab 30 mgRSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 302.640 log10 copies/mLStandard Deviation 0.312
Primary

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

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

Population: 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.

ArmMeasureValue (MEAN)Dispersion
PlaceboRSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 902.500 log10 copies/mLStandard Deviation 0
Motavizumab 30 mgRSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 902.500 log10 copies/mLStandard Deviation 0
Secondary

Change From Baseline in Oxygen Saturation Level

Change from baseline in oxygen saturation level is reported.

Time frame: Baseline (Day 0), Days 2, 7, and 30

Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Oxygen Saturation LevelDay 21.00 Percentage of oxygen saturationStandard Deviation 1.73
PlaceboChange From Baseline in Oxygen Saturation LevelDay 71.20 Percentage of oxygen saturationStandard Deviation 2.17
PlaceboChange From Baseline in Oxygen Saturation LevelDay 301.80 Percentage of oxygen saturationStandard Deviation 1.48
Motavizumab 30 mgChange From Baseline in Oxygen Saturation LevelDay 2-1.00 Percentage of oxygen saturationStandard Deviation 1.58
Motavizumab 30 mgChange From Baseline in Oxygen Saturation LevelDay 70.60 Percentage of oxygen saturationStandard Deviation 1.34
Motavizumab 30 mgChange From Baseline in Oxygen Saturation LevelDay 300.40 Percentage of oxygen saturationStandard Deviation 1.52
Secondary

Change in RACS of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization

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

Population: 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.

Secondary

Duration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation Required

Time frame: Baseline (Day 0) to Day 90

Population: 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.

ArmMeasureGroupValue
UnknownDuration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation RequiredHospitalization—
UnknownDuration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation RequiredSupplemental oxygen—
UnknownDuration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation RequiredMechanical ventilation—
UnknownDuration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation RequiredICU stay—
Secondary

Heart Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization

Time frame: Baseline (Day 0) to Day 30

Population: 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.

Secondary

Motavizumab Concentration in Upper Respiratory Tract

Motavizumab concentration in upper respiratory tract (nasal wash aspirates) is reported.

Time frame: Days 0 (pre-dose), 2, and 30

Population: Evaluable population for pharmacokinetic (PK) included all participants who have received a full dose of study drug.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboMotavizumab Concentration in Upper Respiratory TractDay 0NA ng/mL—
PlaceboMotavizumab Concentration in Upper Respiratory TractDay 21216.186 ng/mLStandard Deviation 1828.934
PlaceboMotavizumab Concentration in Upper Respiratory TractDay 30348.256 ng/mLStandard Deviation 507.979
Secondary

Nasal Wash Cytokine Levels

Nasal wash cytokine levels are reported.

Time frame: Days 0 (pre-dose), 2, 30, and 90

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboNasal Wash Cytokine LevelsIL-1 beta: Day 904.300 pg/mLStandard Deviation 4.391
PlaceboNasal Wash Cytokine LevelsIL-13: Day 28.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-6: Day 906.540 pg/mLStandard Deviation 7.079
PlaceboNasal Wash Cytokine LevelsIL-13: Day 308.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-1 beta: Day 079.380 pg/mLStandard Deviation 164.902
PlaceboNasal Wash Cytokine LevelsIL-13: Day 908.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-7: Day 215.700 pg/mLStandard Deviation 8.895
PlaceboNasal Wash Cytokine LevelsIL-15: Day 301.600 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-2: Day 308.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-15: Day 901.960 pg/mLStandard Deviation 0.805
PlaceboNasal Wash Cytokine LevelsIL-7: Day 308.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-17: Day 02.640 pg/mLStandard Deviation 2.326
PlaceboNasal Wash Cytokine LevelsIL-1 RA: Day 079.200 pg/mLStandard Deviation 88.851
PlaceboNasal Wash Cytokine LevelsIL-17: Day 22.475 pg/mLStandard Deviation 1.75
PlaceboNasal Wash Cytokine LevelsIL-7: Day 9013.460 pg/mLStandard Deviation 7.537
PlaceboNasal Wash Cytokine LevelsIL-17: Day 301.600 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-4: Day 025.820 pg/mLStandard Deviation 34.379
PlaceboNasal Wash Cytokine LevelsIL-17: Day 901.980 pg/mLStandard Deviation 0.85
PlaceboNasal Wash Cytokine LevelsIL-8: Day 0701.600 pg/mLStandard Deviation 746.108
PlaceboNasal Wash Cytokine LevelsEotaxin: Day 014.500 pg/mLStandard Deviation 10.201
PlaceboNasal Wash Cytokine LevelsRantes: Day 301.600 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsEotaxin: Day 217.625 pg/mLStandard Deviation 11.507
PlaceboNasal Wash Cytokine LevelsIL-8: Day 21347.975 pg/mLStandard Deviation 760.276
PlaceboNasal Wash Cytokine LevelsEotaxin: Day 3010.280 pg/mLStandard Deviation 5.098
PlaceboNasal Wash Cytokine LevelsIL-4: Day 28.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsEotaxin: Day 9010.940 pg/mLStandard Deviation 6.574
PlaceboNasal Wash Cytokine LevelsIL-8: Day 30424.040 pg/mLStandard Deviation 881.148
PlaceboNasal Wash Cytokine LevelsIFN gamma: Day 06.740 pg/mLStandard Deviation 11.493
PlaceboNasal Wash Cytokine LevelsIL-1 RA: Day 269.225 pg/mLStandard Deviation 50.434
PlaceboNasal Wash Cytokine LevelsIFN gamma: Day 24.750 pg/mLStandard Deviation 5.17
PlaceboNasal Wash Cytokine LevelsIL-8: Day 90126.260 pg/mLStandard Deviation 151.768
PlaceboNasal Wash Cytokine LevelsIFN gamma: Day 301.600 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-4: Day 308.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIFN gamma: Day 901.940 pg/mLStandard Deviation 0.76
PlaceboNasal Wash Cytokine LevelsIL-9: Day 01.600 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIFN alpha 2: Day 011.580 pg/mLStandard Deviation 8.005
PlaceboNasal Wash Cytokine LevelsIL-1 beta: Day 294.050 pg/mLStandard Deviation 123.565
PlaceboNasal Wash Cytokine LevelsIFN alpha 2: Day 212.075 pg/mLStandard Deviation 8.15
PlaceboNasal Wash Cytokine LevelsIL-9: Day 22.525 pg/mLStandard Deviation 1.85
PlaceboNasal Wash Cytokine LevelsIFN alpha 2: Day 308.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-4: Day 9036.120 pg/mLStandard Deviation 29.029
PlaceboNasal Wash Cytokine LevelsIFN alpha 2: Day 9011.480 pg/mLStandard Deviation 4.774
PlaceboNasal Wash Cytokine LevelsIL-9: Day 301.600 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIP-10: Day 03030.820 pg/mLStandard Deviation 3653.453
PlaceboNasal Wash Cytokine LevelsIL-1 RA: Day 3038.460 pg/mLStandard Deviation 68.111
PlaceboNasal Wash Cytokine LevelsIP-10: Day 22699.550 pg/mLStandard Deviation 3369.371
PlaceboNasal Wash Cytokine LevelsIL-9: Day 901.600 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIP-10: Day 3040.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-5: Day 01.600 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIP-10: Day 90148.980 pg/mLStandard Deviation 90.285
PlaceboNasal Wash Cytokine LevelsIL-10: Day 054.660 pg/mLStandard Deviation 94.235
PlaceboNasal Wash Cytokine LevelsMCP-1: Day 0138.280 pg/mLStandard Deviation 261.81
PlaceboNasal Wash Cytokine LevelsIL-15: Day 23.275 pg/mLStandard Deviation 2.311
PlaceboNasal Wash Cytokine LevelsMCP-1: Day 267.950 pg/mLStandard Deviation 72.134
PlaceboNasal Wash Cytokine LevelsIL-10: Day 234.650 pg/mLStandard Deviation 55.865
PlaceboNasal Wash Cytokine LevelsMCP-1: Day 3015.160 pg/mLStandard Deviation 16.01
PlaceboNasal Wash Cytokine LevelsIL-5: Day 21.600 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsMCP-1: Day 9013.580 pg/mLStandard Deviation 7.651
PlaceboNasal Wash Cytokine LevelsIL-10 Day 303.180 pg/mLStandard Deviation 3.533
PlaceboNasal Wash Cytokine LevelsMIP-1 alpha: Day 0229.060 pg/mLStandard Deviation 463.273
PlaceboNasal Wash Cytokine LevelsIL-7: Day 015.220 pg/mLStandard Deviation 7.083
PlaceboNasal Wash Cytokine LevelsMIP-1 alpha: Day 296.875 pg/mLStandard Deviation 102.773
PlaceboNasal Wash Cytokine LevelsIL-10: Day 904.700 pg/mLStandard Deviation 4.699
PlaceboNasal Wash Cytokine LevelsMIP-1 alpha: Day 3034.720 pg/mLStandard Deviation 59.748
PlaceboNasal Wash Cytokine LevelsIL-5: Day301.600 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsMIP-1 alpha: Day 9015.420 pg/mLStandard Deviation 16.592
PlaceboNasal Wash Cytokine LevelsIL-11: Day 09.750 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsMIP-1 beta: Day 0113.840 pg/mLStandard Deviation 211.563
PlaceboNasal Wash Cytokine LevelsIL-1 beta: Day 3010.520 pg/mLStandard Deviation 19.946
PlaceboNasal Wash Cytokine LevelsMIP-1 beta: Day 274.850 pg/mLStandard Deviation 53.517
PlaceboNasal Wash Cytokine LevelsIL-11: Day 29.750 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsMIP-1 beta: Day 3018.480 pg/mLStandard Deviation 23.434
PlaceboNasal Wash Cytokine LevelsIL-5: Day 901.600 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsMIP-1 beta: Day 9014.560 pg/mLStandard Deviation 14.669
PlaceboNasal Wash Cytokine LevelsIL-11: Day 309.750 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsRantes: Day 0197.860 pg/mLStandard Deviation 404.89
PlaceboNasal Wash Cytokine LevelsIL-1 RA: Day 9024.100 pg/mLStandard Deviation 22.976
PlaceboNasal Wash Cytokine LevelsRantes: Day 223.400 pg/mLStandard Deviation 15.609
PlaceboNasal Wash Cytokine LevelsIL-11: Day 909.750 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-6: Day 0172.480 pg/mLStandard Deviation 327.548
PlaceboNasal Wash Cytokine LevelsRantes: Day 904.260 pg/mLStandard Deviation 3.717
PlaceboNasal Wash Cytokine LevelsIL-12 P70: Day 011.380 pg/mLStandard Deviation 7.558
PlaceboNasal Wash Cytokine LevelsTNF alpha: Day 0104.180 pg/mLStandard Deviation 222.984
PlaceboNasal Wash Cytokine LevelsIL-15: Day 02.900 pg/mLStandard Deviation 2.907
PlaceboNasal Wash Cytokine LevelsTNF alpha: Day 229.425 pg/mLStandard Deviation 30.522
PlaceboNasal Wash Cytokine LevelsIL-12 P70: Day 28.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsTNF alpha: Day 303.440 pg/mLStandard Deviation 4.114
PlaceboNasal Wash Cytokine LevelsIL-6: Day 242.950 pg/mLStandard Deviation 28.197
PlaceboNasal Wash Cytokine LevelsTNF alpha: Day 903.980 pg/mLStandard Deviation 5.322
PlaceboNasal Wash Cytokine LevelsIL-12 P70: Day 308.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsSIL-2R alpha: Day 010.500 pg/mLStandard Deviation 5.59
PlaceboNasal Wash Cytokine LevelsIL-2: Day 08.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsSIL-2R alpha: Day 210.000 pg/mLStandard Deviation 4
PlaceboNasal Wash Cytokine LevelsIL-12 P70: Day 908.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsSIL-2R alpha: Day 308.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-6: Day 303.300 pg/mLStandard Deviation 3.801
PlaceboNasal Wash Cytokine LevelsSIL-2R alpha: Day 908.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-13: Day 08.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-2: Day 908.000 pg/mLStandard Deviation 0
PlaceboNasal Wash Cytokine LevelsIL-2: Day 28.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-2: Day 908.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-15: Day 06.580 pg/mLStandard Deviation 4.089
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-15: Day 27.900 pg/mLStandard Deviation 1.418
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-1 beta: Day 0282.380 pg/mLStandard Deviation 355.694
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-1 beta: Day 2144.367 pg/mLStandard Deviation 113.883
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-1 beta: Day 30156.240 pg/mLStandard Deviation 336.673
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-1 beta: Day 902.680 pg/mLStandard Deviation 2.415
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-1 RA: Day 0205.040 pg/mLStandard Deviation 249.143
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-1 RA: Day 2255.533 pg/mLStandard Deviation 184.664
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-6: Day 907.300 pg/mLStandard Deviation 6.3
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-1 RA: Day 3094.600 pg/mLStandard Deviation 123.754
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-1 RA: Day 9039.240 pg/mLStandard Deviation 30.922
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-2: Day 08.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-2: Day 28.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-2: Day 308.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-4: Day 014.160 pg/mLStandard Deviation 13.774
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-4: Day 222.300 pg/mLStandard Deviation 17.419
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-4: Day 308.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-4: Day 908.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-5: Day 01.600 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-5: Day 21.600 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-5: Day301.600 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-5: Day 901.600 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-6: Day 0411.320 pg/mLStandard Deviation 477.909
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-6: Day 2278.467 pg/mLStandard Deviation 231.477
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-6: Day 3019.440 pg/mLStandard Deviation 21.978
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-7: Day 019.480 pg/mLStandard Deviation 12.696
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-7: Day 230.567 pg/mLStandard Deviation 10.058
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-7: Day 308.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-7: Day 9011.620 pg/mLStandard Deviation 8.095
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-8: Day 01488.540 pg/mLStandard Deviation 791.215
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-8: Day 22000.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-8: Day 30942.360 pg/mLStandard Deviation 976.506
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-8: Day 90312.760 pg/mLStandard Deviation 269.98
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-9: Day 01.920 pg/mLStandard Deviation 0.716
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-9: Day 24.400 pg/mLStandard Deviation 3.208
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-9: Day 301.600 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-9: Day 901.600 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-10: Day 036.840 pg/mLStandard Deviation 31.4
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-10: Day 2115.867 pg/mLStandard Deviation 123.508
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-10 Day 3015.340 pg/mLStandard Deviation 20.013
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-10: Day 902.820 pg/mLStandard Deviation 2.728
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-11: Day 09.750 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-11: Day 29.750 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-11: Day 309.750 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-11: Day 909.750 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-12 P70: Day 010.240 pg/mLStandard Deviation 5.009
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-12 P70: Day 210.967 pg/mLStandard Deviation 5.138
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-12 P70: Day 308.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-12 P70: Day 908.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-13: Day 08.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-13: Day 211.033 pg/mLStandard Deviation 5.254
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-13: Day 308.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-13: Day 908.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-15: Day 302.580 pg/mLStandard Deviation 1.47
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-15: Day 902.300 pg/mLStandard Deviation 1.565
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-17: Day 03.060 pg/mLStandard Deviation 2.024
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-17: Day 22.900 pg/mLStandard Deviation 2.252
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-17: Day 301.600 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIL-17: Day 901.600 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsEotaxin: Day 020.620 pg/mLStandard Deviation 8.461
Motavizumab 30 mgNasal Wash Cytokine LevelsEotaxin: Day 229.300 pg/mLStandard Deviation 7.758
Motavizumab 30 mgNasal Wash Cytokine LevelsEotaxin: Day 3015.420 pg/mLStandard Deviation 11.445
Motavizumab 30 mgNasal Wash Cytokine LevelsEotaxin: Day 9010.540 pg/mLStandard Deviation 5.68
Motavizumab 30 mgNasal Wash Cytokine LevelsIFN gamma: Day 05.760 pg/mLStandard Deviation 2.788
Motavizumab 30 mgNasal Wash Cytokine LevelsIFN gamma: Day 29.433 pg/mLStandard Deviation 4.14
Motavizumab 30 mgNasal Wash Cytokine LevelsIFN gamma: Day 301.600 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIFN gamma: Day 902.080 pg/mLStandard Deviation 1.073
Motavizumab 30 mgNasal Wash Cytokine LevelsIFN alpha 2: Day 016.900 pg/mLStandard Deviation 8.306
Motavizumab 30 mgNasal Wash Cytokine LevelsIFN alpha 2: Day 219.800 pg/mLStandard Deviation 11.377
Motavizumab 30 mgNasal Wash Cytokine LevelsIFN alpha 2: Day 308.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsIFN alpha 2: Day 9011.220 pg/mLStandard Deviation 7.2
Motavizumab 30 mgNasal Wash Cytokine LevelsIP-10: Day 05850.060 pg/mLStandard Deviation 4510.86
Motavizumab 30 mgNasal Wash Cytokine LevelsIP-10: Day 24405.733 pg/mLStandard Deviation 4604.409
Motavizumab 30 mgNasal Wash Cytokine LevelsIP-10: Day 301378.140 pg/mLStandard Deviation 1435.513
Motavizumab 30 mgNasal Wash Cytokine LevelsIP-10: Day 90344.720 pg/mLStandard Deviation 201.758
Motavizumab 30 mgNasal Wash Cytokine LevelsMCP-1: Day 0352.860 pg/mLStandard Deviation 400.479
Motavizumab 30 mgNasal Wash Cytokine LevelsMCP-1: Day 2204.000 pg/mLStandard Deviation 239.883
Motavizumab 30 mgNasal Wash Cytokine LevelsMCP-1: Day 3075.900 pg/mLStandard Deviation 69.833
Motavizumab 30 mgNasal Wash Cytokine LevelsMCP-1: Day 9030.580 pg/mLStandard Deviation 21.161
Motavizumab 30 mgNasal Wash Cytokine LevelsMIP-1 alpha: Day 0116.280 pg/mLStandard Deviation 109.432
Motavizumab 30 mgNasal Wash Cytokine LevelsMIP-1 alpha: Day 263.300 pg/mLStandard Deviation 57.022
Motavizumab 30 mgNasal Wash Cytokine LevelsMIP-1 alpha: Day 3083.880 pg/mLStandard Deviation 118.987
Motavizumab 30 mgNasal Wash Cytokine LevelsMIP-1 alpha: Day 908.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsMIP-1 beta: Day 088.340 pg/mLStandard Deviation 91.09
Motavizumab 30 mgNasal Wash Cytokine LevelsMIP-1 beta: Day 254.467 pg/mLStandard Deviation 30.928
Motavizumab 30 mgNasal Wash Cytokine LevelsMIP-1 beta: Day 3047.700 pg/mLStandard Deviation 71.854
Motavizumab 30 mgNasal Wash Cytokine LevelsMIP-1 beta: Day 9010.480 pg/mLStandard Deviation 5.545
Motavizumab 30 mgNasal Wash Cytokine LevelsRantes: Day 056.720 pg/mLStandard Deviation 72.686
Motavizumab 30 mgNasal Wash Cytokine LevelsRantes: Day 290.067 pg/mLStandard Deviation 116.383
Motavizumab 30 mgNasal Wash Cytokine LevelsRantes: Day 3060.560 pg/mLStandard Deviation 97.653
Motavizumab 30 mgNasal Wash Cytokine LevelsRantes: Day 905.140 pg/mLStandard Deviation 5.594
Motavizumab 30 mgNasal Wash Cytokine LevelsTNF alpha: Day 0133.220 pg/mLStandard Deviation 122.334
Motavizumab 30 mgNasal Wash Cytokine LevelsTNF alpha: Day 244.133 pg/mLStandard Deviation 34.563
Motavizumab 30 mgNasal Wash Cytokine LevelsTNF alpha: Day 3022.340 pg/mLStandard Deviation 32.064
Motavizumab 30 mgNasal Wash Cytokine LevelsTNF alpha: Day 902.020 pg/mLStandard Deviation 0.939
Motavizumab 30 mgNasal Wash Cytokine LevelsSIL-2R alpha: Day 014.580 pg/mLStandard Deviation 9.265
Motavizumab 30 mgNasal Wash Cytokine LevelsSIL-2R alpha: Day 213.167 pg/mLStandard Deviation 8.949
Motavizumab 30 mgNasal Wash Cytokine LevelsSIL-2R alpha: Day 308.000 pg/mLStandard Deviation 0
Motavizumab 30 mgNasal Wash Cytokine LevelsSIL-2R alpha: Day 908.000 pg/mLStandard Deviation 0
Secondary

Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications

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

Population: Safety population included all participants who had received any study drug and had any follow-up. Participants with LRI were analyzed for this outcome.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PlaceboNumber of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory MedicationsHospitalization0 Participants
PlaceboNumber of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory MedicationsMechanical ventilation0 Participants
PlaceboNumber of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory MedicationsRespiratory medication0 Participants
PlaceboNumber of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory MedicationsICU stay0 Participants
PlaceboNumber of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory MedicationsSupplemental oxygen0 Participants
Motavizumab 30 mgNumber of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory MedicationsRespiratory medication0 Participants
Motavizumab 30 mgNumber of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory MedicationsHospitalization0 Participants
Motavizumab 30 mgNumber of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory MedicationsSupplemental oxygen0 Participants
Motavizumab 30 mgNumber of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory MedicationsMechanical ventilation0 Participants
Motavizumab 30 mgNumber of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory MedicationsICU stay0 Participants
Secondary

Number of Participants Who Progresses From Upper Respiratory Tract Infection to Lower Respiratory Tract Infection (LRI)

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

Population: Safety population included all participants who had received any study drug and had any follow-up.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PlaceboNumber of Participants Who Progresses From Upper Respiratory Tract Infection to Lower Respiratory Tract Infection (LRI)0 Participants
Motavizumab 30 mgNumber of Participants Who Progresses From Upper Respiratory Tract Infection to Lower Respiratory Tract Infection (LRI)1 Participants
Secondary

Number of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical Ventilation

Number of participants who required hospitalization, ICU stay, supplemental oxygen, and mechanical ventilation is reported.

Time frame: Baseline (Day 0) to Day 90

Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PlaceboNumber of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical VentilationHospitalization0 Participants
PlaceboNumber of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical VentilationSupplemental oxygen0 Participants
PlaceboNumber of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical VentilationMechanical ventilation0 Participants
PlaceboNumber of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical VentilationICU stay0 Participants
Motavizumab 30 mgNumber of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical VentilationICU stay0 Participants
Motavizumab 30 mgNumber of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical VentilationHospitalization0 Participants
Motavizumab 30 mgNumber of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical VentilationMechanical ventilation0 Participants
Motavizumab 30 mgNumber of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical VentilationSupplemental oxygen0 Participants
Secondary

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

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

Time frame: From the administration of study drug (Day 0) through Day 90

Population: Safety population included all participants who had received any study drug and had any follow-up.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PlaceboNumber of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)TEAEs5 Participants
PlaceboNumber of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)TESAEs2 Participants
Motavizumab 30 mgNumber of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)TEAEs6 Participants
Motavizumab 30 mgNumber of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)TESAEs0 Participants
Secondary

Numbers of Participants With Positive Anti-Motavizumab Antibodies

The number of participants with positive serum antibodies to motavizumab are reported.

Time frame: Days 0 (pre-dose) and 90

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PlaceboNumbers of Participants With Positive Anti-Motavizumab AntibodiesDay 00 Participants
PlaceboNumbers of Participants With Positive Anti-Motavizumab AntibodiesDay 900 Participants
Secondary

Oxygen Saturation Levels in RSV-infected Outpatient Participants Who Subsequently Required Hospitalization

Time frame: Baseline (Day 0) to Day 30

Population: 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.

Secondary

Percentage of Participants Who Have Progression of RSV Illness That Requires Subsequent Hospitalization

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

Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR.

ArmMeasureValue (NUMBER)
PlaceboPercentage of Participants Who Have Progression of RSV Illness That Requires Subsequent Hospitalization0 Percentage of participants
Motavizumab 30 mgPercentage of Participants Who Have Progression of RSV Illness That Requires Subsequent Hospitalization0 Percentage of participants
Secondary

RACS in Participants With LRI

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

Population: Safety population included all participants who had received any study drug and had any follow-up. Participants with LRI were analyzed for this outcome.

ArmMeasureGroupValue (MEAN)
Motavizumab 30 mgRACS in Participants With LRIDay 212 Units on a score
Motavizumab 30 mgRACS in Participants With LRIDay 7-4 Units on a score
Motavizumab 30 mgRACS in Participants With LRIDay 30-1 Units on a score
Secondary

Respiratory Assessment Change Score (RACS) Derived From Baseline

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

Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboRespiratory Assessment Change Score (RACS) Derived From BaselineDay 21.80 Units on a scoreStandard Deviation 4.09
PlaceboRespiratory Assessment Change Score (RACS) Derived From BaselineDay 7-0.20 Units on a scoreStandard Deviation 4.82
PlaceboRespiratory Assessment Change Score (RACS) Derived From BaselineDay 30-1.40 Units on a scoreStandard Deviation 4.51
Motavizumab 30 mgRespiratory Assessment Change Score (RACS) Derived From BaselineDay 22.20 Units on a scoreStandard Deviation 5.81
Motavizumab 30 mgRespiratory Assessment Change Score (RACS) Derived From BaselineDay 7-2.00 Units on a scoreStandard Deviation 1.58
Motavizumab 30 mgRespiratory Assessment Change Score (RACS) Derived From BaselineDay 30-2.00 Units on a scoreStandard Deviation 4.18
Secondary

Respiratory Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization

Time frame: Baseline (Day 0) to Day 30

Population: 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.

Secondary

Serum Concentration of Motavizumab

Serum concentration of motavizumab is reported.

Time frame: Days 2, 30, and 90

Population: Evaluable population for PK included all participants who have received a full dose of study drug.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboSerum Concentration of MotavizumabDay 2216.761 mcg/mLStandard Deviation 43.867
PlaceboSerum Concentration of MotavizumabDay 30126.296 mcg/mLStandard Deviation 25.013
PlaceboSerum Concentration of MotavizumabDay 9023.799 mcg/mLStandard Deviation 9.81
Secondary

Serum Cytokine Levels

Serum Cytokine Levels are reported.

Time frame: Days 0 (pre-dose), 30, and 90

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboSerum Cytokine LevelsIL-7: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIL-4: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIL-13: Day 908.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIL-7: Day 908.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIL-15: Day 01.600 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIL-1 receptor antagonist (RA): Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIL-15: Day 301.600 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIL-8: Day 028.500 Picograms per millilitre (pg/mL)Standard Deviation 1.728
PlaceboSerum Cytokine LevelsIL-15: Day 902.100 Picograms per millilitre (pg/mL)Standard Deviation 1
PlaceboSerum Cytokine LevelsIL-4: Day 9010.900 Picograms per millilitre (pg/mL)Standard Deviation 5.8
PlaceboSerum Cytokine LevelsIL-17: Day 02.160 Picograms per millilitre (pg/mL)Standard Deviation 1.252
PlaceboSerum Cytokine LevelsIL-8: Day 3012.900 Picograms per millilitre (pg/mL)Standard Deviation 4.678
PlaceboSerum Cytokine LevelsIL-17: Day 302.675 Picograms per millilitre (pg/mL)Standard Deviation 2.15
PlaceboSerum Cytokine LevelsIL-2: Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIL-17: Day 9029.875 Picograms per millilitre (pg/mL)Standard Deviation 37.289
PlaceboSerum Cytokine LevelsIL-8: Day 9038.475 Picograms per millilitre (pg/mL)Standard Deviation 43.752
PlaceboSerum Cytokine LevelsEotaxin: Day 0120.860 Picograms per millilitre (pg/mL)Standard Deviation 53.095
PlaceboSerum Cytokine LevelsEotaxin: Day 30117.500 Picograms per millilitre (pg/mL)Standard Deviation 54.553
PlaceboSerum Cytokine LevelsIL-5: Day 01.600 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsEotaxin: Day 90139.275 Picograms per millilitre (pg/mL)Standard Deviation 32.062
PlaceboSerum Cytokine LevelsIL-9: Day 01.600 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsInterferon (IFN) gamma: Day 016.020 Picograms per millilitre (pg/mL)Standard Deviation 10.991
PlaceboSerum Cytokine LevelsIL-1 beta: Day 908.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIFN gamma: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIL-9: Day 301.600 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIFN gamma: Day 90115.675 Picograms per millilitre (pg/mL)Standard Deviation 125.181
PlaceboSerum Cytokine LevelsIL-5: Day 301.600 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIFN alpha 2: Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIL-9: Day 907.925 Picograms per millilitre (pg/mL)Standard Deviation 6.758
PlaceboSerum Cytokine LevelsIFN alpha 2: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIL-2: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIFN alpha 2: Day 9020.175 Picograms per millilitre (pg/mL)Standard Deviation 24.35
PlaceboSerum Cytokine LevelsIL-10: Day 036.400 Picograms per millilitre (pg/mL)Standard Deviation 28.205
PlaceboSerum Cytokine LevelsIFN gamma induced protein (IP)-10: Day 0605.740 Picograms per millilitre (pg/mL)Standard Deviation 299.105
PlaceboSerum Cytokine LevelsIL-5: Day 9019.925 Picograms per millilitre (pg/mL)Standard Deviation 35.46
PlaceboSerum Cytokine LevelsIP-10: Day 30518.775 Picograms per millilitre (pg/mL)Standard Deviation 617.131
PlaceboSerum Cytokine LevelsIL-10: Day 3019.325 Picograms per millilitre (pg/mL)Standard Deviation 13.297
PlaceboSerum Cytokine LevelsIP-10: Day 90310.150 Picograms per millilitre (pg/mL)Standard Deviation 154.371
PlaceboSerum Cytokine LevelsIL-1 RA: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsMonocyte Chemoattractant Protein-1 (MCP-1): Day 0729.860 Picograms per millilitre (pg/mL)Standard Deviation 248.023
PlaceboSerum Cytokine LevelsIL-10: Day 9013.900 Picograms per millilitre (pg/mL)Standard Deviation 7.161
PlaceboSerum Cytokine LevelsMCP-1: Day 30728.225 Picograms per millilitre (pg/mL)Standard Deviation 245.66
PlaceboSerum Cytokine LevelsIL-6: Day 02.620 Picograms per millilitre (pg/mL)Standard Deviation 2.281
PlaceboSerum Cytokine LevelsMCP-1: Day 90596.125 Picograms per millilitre (pg/mL)Standard Deviation 154.409
PlaceboSerum Cytokine LevelsIL-11: Day 013.133 Picograms per millilitre (pg/mL)Standard Deviation 5.86
PlaceboSerum Cytokine LevelsMacrophage inflammatory protein (MIP)-1 alpha:Day08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsIL-2: Day 908.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsMIP-1 alpha:Day 3010.000 Picograms per millilitre (pg/mL)Standard Deviation 4
PlaceboSerum Cytokine LevelsIL-11: Day 3015.600 Picograms per millilitre (pg/mL)Standard Deviation 10.132
PlaceboSerum Cytokine LevelsMIP-1 alpha: Day 9025.375 Picograms per millilitre (pg/mL)Standard Deviation 15.504
PlaceboSerum Cytokine LevelsIL-6: Day 301.600 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsMIP-1 beta: Day 099.560 Picograms per millilitre (pg/mL)Standard Deviation 40.959
PlaceboSerum Cytokine LevelsIL-11: Day 90148.483 Picograms per millilitre (pg/mL)Standard Deviation 143.545
PlaceboSerum Cytokine LevelsMIP-1 beta: Day 3092.513 Picograms per millilitre (pg/mL)Standard Deviation 52.444
PlaceboSerum Cytokine LevelsIL-1 beta: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsMIP-1 beta: Day 90117.300 Picograms per millilitre (pg/mL)Standard Deviation 43.226
PlaceboSerum Cytokine LevelsIL-12 P70: Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsRantes: Day 023103.400 Picograms per millilitre (pg/mL)Standard Deviation 10200.333
PlaceboSerum Cytokine LevelsIL-6: Day 9022.950 Picograms per millilitre (pg/mL)Standard Deviation 16.093
PlaceboSerum Cytokine LevelsRantes: Day 3026038.788 Picograms per millilitre (pg/mL)Standard Deviation 3942.021
PlaceboSerum Cytokine LevelsIL-12 P70: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsRantes: Day 9041813.725 Picograms per millilitre (pg/mL)Standard Deviation 45065.022
PlaceboSerum Cytokine LevelsIL-4: Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsTNF alpha: Day 025.320 Picograms per millilitre (pg/mL)Standard Deviation 9.373
PlaceboSerum Cytokine LevelsIL-12 P70: Day 9020.450 Picograms per millilitre (pg/mL)Standard Deviation 24.9
PlaceboSerum Cytokine LevelsTNF alpha: Day 3021.925 Picograms per millilitre (pg/mL)Standard Deviation 7.509
PlaceboSerum Cytokine LevelsIL-7: Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsTNF alpha: Day 9021.925 Picograms per millilitre (pg/mL)Standard Deviation 6.879
PlaceboSerum Cytokine LevelsIL-13: Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsSoluble IL-2 receptor (SIL-2R) alpha: Day 0116.500 Picograms per millilitre (pg/mL)Standard Deviation 81.702
PlaceboSerum Cytokine LevelsIL-1 RA: Day 9011.000 Picograms per millilitre (pg/mL)Standard Deviation 6
PlaceboSerum Cytokine LevelssIL-2R alpha: Day 30117.988 Picograms per millilitre (pg/mL)Standard Deviation 93.112
PlaceboSerum Cytokine LevelsIL-13: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
PlaceboSerum Cytokine LevelsSIL-2R alpha: Day 9072.325 Picograms per millilitre (pg/mL)Standard Deviation 12.848
PlaceboSerum Cytokine LevelsInterleukin 1 (IL-1) beta: Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsSIL-2R alpha: Day 9084.060 Picograms per millilitre (pg/mL)Standard Deviation 48.465
Motavizumab 30 mgSerum Cytokine LevelsInterleukin 1 (IL-1) beta: Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-1 beta: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-1 beta: Day 908.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-1 receptor antagonist (RA): Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-1 RA: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-1 RA: Day 9010.960 Picograms per millilitre (pg/mL)Standard Deviation 6.619
Motavizumab 30 mgSerum Cytokine LevelsIL-2: Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-2: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-2: Day 908.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-4: Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-4: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-4: Day 9013.060 Picograms per millilitre (pg/mL)Standard Deviation 11.315
Motavizumab 30 mgSerum Cytokine LevelsIL-5: Day 01.600 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-5: Day 301.600 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-5: Day 903.080 Picograms per millilitre (pg/mL)Standard Deviation 3.309
Motavizumab 30 mgSerum Cytokine LevelsIL-6: Day 012.025 Picograms per millilitre (pg/mL)Standard Deviation 8.247
Motavizumab 30 mgSerum Cytokine LevelsIL-6: Day 301.980 Picograms per millilitre (pg/mL)Standard Deviation 0.85
Motavizumab 30 mgSerum Cytokine LevelsIL-6: Day 904.040 Picograms per millilitre (pg/mL)Standard Deviation 3.335
Motavizumab 30 mgSerum Cytokine LevelsIL-7: Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-7: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-7: Day 908.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-8: Day 028.525 Picograms per millilitre (pg/mL)Standard Deviation 14.061
Motavizumab 30 mgSerum Cytokine LevelsIL-8: Day 307.900 Picograms per millilitre (pg/mL)Standard Deviation 2.904
Motavizumab 30 mgSerum Cytokine LevelsIL-8: Day 9012.120 Picograms per millilitre (pg/mL)Standard Deviation 4.727
Motavizumab 30 mgSerum Cytokine LevelsIL-9: Day 01.600 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-9: Day 303.020 Picograms per millilitre (pg/mL)Standard Deviation 3.175
Motavizumab 30 mgSerum Cytokine LevelsIL-9: Day 904.200 Picograms per millilitre (pg/mL)Standard Deviation 4.591
Motavizumab 30 mgSerum Cytokine LevelsIL-10: Day 029.625 Picograms per millilitre (pg/mL)Standard Deviation 31.852
Motavizumab 30 mgSerum Cytokine LevelsIL-10: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-10: Day 908.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-11: Day 09.750 Picograms per millilitre (pg/mL)—
Motavizumab 30 mgSerum Cytokine LevelsIL-11: Day 3027.000 Picograms per millilitre (pg/mL)Standard Deviation 29.878
Motavizumab 30 mgSerum Cytokine LevelsIL-11: Day 9038.783 Picograms per millilitre (pg/mL)Standard Deviation 32.632
Motavizumab 30 mgSerum Cytokine LevelsIL-12 P70: Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-12 P70: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-12 P70: Day 908.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-13: Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-13: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsEotaxin: Day 0116.325 Picograms per millilitre (pg/mL)Standard Deviation 15.866
Motavizumab 30 mgSerum Cytokine LevelsIL-13: Day 9011.060 Picograms per millilitre (pg/mL)Standard Deviation 6.842
Motavizumab 30 mgSerum Cytokine LevelsIL-15: Day 01.600 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-15: Day 301.600 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-15: Day 901.600 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-17: Day 01.600 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-17: Day 301.600 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIL-17: Day 905.180 Picograms per millilitre (pg/mL)Standard Deviation 6.324
Motavizumab 30 mgSerum Cytokine LevelsEotaxin: Day 30105.720 Picograms per millilitre (pg/mL)Standard Deviation 19.212
Motavizumab 30 mgSerum Cytokine LevelsEotaxin: Day 9087.960 Picograms per millilitre (pg/mL)Standard Deviation 29.43
Motavizumab 30 mgSerum Cytokine LevelsInterferon (IFN) gamma: Day 08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIFN gamma: Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsIFN gamma: Day 9014.740 Picograms per millilitre (pg/mL)Standard Deviation 10.698
Motavizumab 30 mgSerum Cytokine LevelsIFN alpha 2: Day 012.000 Picograms per millilitre (pg/mL)Standard Deviation 8
Motavizumab 30 mgSerum Cytokine LevelsIFN alpha 2: Day 3012.060 Picograms per millilitre (pg/mL)Standard Deviation 9.078
Motavizumab 30 mgSerum Cytokine LevelsIFN alpha 2: Day 9012.220 Picograms per millilitre (pg/mL)Standard Deviation 5.792
Motavizumab 30 mgSerum Cytokine LevelsIFN gamma induced protein (IP)-10: Day 0723.950 Picograms per millilitre (pg/mL)Standard Deviation 442.489
Motavizumab 30 mgSerum Cytokine LevelsIP-10: Day 30136.360 Picograms per millilitre (pg/mL)Standard Deviation 59.356
Motavizumab 30 mgSerum Cytokine LevelsIP-10: Day 90287.000 Picograms per millilitre (pg/mL)Standard Deviation 58.101
Motavizumab 30 mgSerum Cytokine LevelsMonocyte Chemoattractant Protein-1 (MCP-1): Day 0717.850 Picograms per millilitre (pg/mL)Standard Deviation 585.336
Motavizumab 30 mgSerum Cytokine LevelsMCP-1: Day 30727.620 Picograms per millilitre (pg/mL)Standard Deviation 635.702
Motavizumab 30 mgSerum Cytokine LevelsMCP-1: Day 90542.320 Picograms per millilitre (pg/mL)Standard Deviation 294.697
Motavizumab 30 mgSerum Cytokine LevelsMacrophage inflammatory protein (MIP)-1 alpha:Day08.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsMIP-1 alpha:Day 308.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsMIP-1 alpha: Day 908.000 Picograms per millilitre (pg/mL)Standard Deviation 0
Motavizumab 30 mgSerum Cytokine LevelsMIP-1 beta: Day 070.150 Picograms per millilitre (pg/mL)Standard Deviation 40.912
Motavizumab 30 mgSerum Cytokine LevelsMIP-1 beta: Day 3095.700 Picograms per millilitre (pg/mL)Standard Deviation 58.14
Motavizumab 30 mgSerum Cytokine LevelsMIP-1 beta: Day 9077.780 Picograms per millilitre (pg/mL)Standard Deviation 39.844
Motavizumab 30 mgSerum Cytokine LevelsRantes: Day 035348.767 Picograms per millilitre (pg/mL)Standard Deviation 11488.336
Motavizumab 30 mgSerum Cytokine LevelsRantes: Day 3029950.000 Picograms per millilitre (pg/mL)Standard Deviation 13143.128
Motavizumab 30 mgSerum Cytokine LevelsRantes: Day 9030770.200 Picograms per millilitre (pg/mL)Standard Deviation 15335.152
Motavizumab 30 mgSerum Cytokine LevelsTNF alpha: Day 023.075 Picograms per millilitre (pg/mL)Standard Deviation 4.802
Motavizumab 30 mgSerum Cytokine LevelsTNF alpha: Day 3021.200 Picograms per millilitre (pg/mL)Standard Deviation 5.482
Motavizumab 30 mgSerum Cytokine LevelsTNF alpha: Day 9021.040 Picograms per millilitre (pg/mL)Standard Deviation 6.474
Motavizumab 30 mgSerum Cytokine LevelsSoluble IL-2 receptor (SIL-2R) alpha: Day 0165.425 Picograms per millilitre (pg/mL)Standard Deviation 78.977
Motavizumab 30 mgSerum Cytokine LevelssIL-2R alpha: Day 30108.060 Picograms per millilitre (pg/mL)Standard Deviation 49.831

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026