Trial Outcomes & Findings for MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States (NCT NCT00121108)
NCT ID: NCT00121108
Last Updated: 2022-01-05
Results Overview
An RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive central real-time reverse transcription polymerase chain reaction (RT-PCR) RSV test collected within 3 days of hospitalization or 2) new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2127 participants
Primary outcome timeframe
From study Day 0 through study Day 150
Results posted on
2022-01-05
Participant Flow
The study was conducted from 15 Nov 2004 to 27 Dec 2010 in the United States of America.
Participant milestones
| Measure |
Placebo
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
Motavizumab
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Overall Study
STARTED
|
710
|
1417
|
|
Overall Study
COMPLETED
|
589
|
1192
|
|
Overall Study
NOT COMPLETED
|
121
|
225
|
Reasons for withdrawal
| Measure |
Placebo
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
Motavizumab
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
22
|
|
Overall Study
Withdrawal by Subject
|
106
|
195
|
|
Overall Study
Death
|
5
|
8
|
Baseline Characteristics
MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
Baseline characteristics by cohort
| Measure |
Placebo
n=710 Participants
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
Motavizumab
n=1417 Participants
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
Total
n=2127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.13 Months
STANDARD_DEVIATION 1.89 • n=93 Participants
|
2.08 Months
STANDARD_DEVIATION 1.92 • n=4 Participants
|
2.10 Months
STANDARD_DEVIATION 1.91 • n=27 Participants
|
|
Sex: Female, Male
Female
|
343 Participants
n=93 Participants
|
710 Participants
n=4 Participants
|
1053 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
367 Participants
n=93 Participants
|
707 Participants
n=4 Participants
|
1074 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Navajo
|
576 Participants
n=93 Participants
|
1149 Participants
n=4 Participants
|
1725 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White Mountain Apache
|
102 Participants
n=93 Participants
|
203 Participants
n=4 Participants
|
305 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
San Carlos Apache
|
15 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Zuni
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hopi
|
8 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other - Not specified
|
9 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From study Day 0 through study Day 150Population: The ITT population included all participants in the treatment group according to their randomized treatment group.
An RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive central real-time reverse transcription polymerase chain reaction (RT-PCR) RSV test collected within 3 days of hospitalization or 2) new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test.
Outcome measures
| Measure |
Placebo
n=710 Participants
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
Motavizumab
n=1417 Participants
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization
|
80 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: From study Day 0 through study Day 150Population: Safety population included all the participants who received any study drug.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Outcome measures
| Measure |
Placebo
n=708 Participants
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
Motavizumab
n=1414 Participants
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
|
686 Participants
|
1361 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
|
148 Participants
|
212 Participants
|
SECONDARY outcome
Timeframe: From study Day 0 through study Day 150Population: The ITT population included all participants in the treatment group according to their randomized treatment group.
The RSV outpatient MA LRI was defined as an outpatient medically attended event designated as a lower respiratory illness with a positive RT-PCR RSV test. An 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 was determined by the principal investigator after review of the medical record and considering the presence of cough, retractions, rhonchi, wheezing, crackles, or rales, associated with symptoms (by history or clinical findings) of coryza, fever, or apnoea.
Outcome measures
| Measure |
Placebo
n=710 Participants
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
Motavizumab
n=1417 Participants
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI)
|
71 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: From study Day 0 through study Day 150Population: The ITT population included all participants in the treatment group according to their randomized treatment group.
Otitis media (OM) was recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not recorded as a new OM event.
Outcome measures
| Measure |
Placebo
n=710 Participants
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
Motavizumab
n=1417 Participants
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Number of Participants With Medically Attended-Otitis Media (MA-OM) Events
|
275 Participants
|
532 Participants
|
SECONDARY outcome
Timeframe: From study Day 0 through study Day 150Population: The ITT population included all participants in the treatment group according to their randomized treatment group.
Otitis media was recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute TM perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not recorded as a new OM event. Number of participants with frequency of MA-OM events (either 0, 1, 2, 3, or greater than \[\>\] 3) are reported.
Outcome measures
| Measure |
Placebo
n=710 Participants
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
Motavizumab
n=1417 Participants
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Number of Participants With Frequency of MA-OM Events
MA OM: 0
|
435 Participants
|
885 Participants
|
|
Number of Participants With Frequency of MA-OM Events
MA OM: 1
|
190 Participants
|
372 Participants
|
|
Number of Participants With Frequency of MA-OM Events
MA OM: 2
|
55 Participants
|
114 Participants
|
|
Number of Participants With Frequency of MA-OM Events
MA OM: 3
|
26 Participants
|
32 Participants
|
|
Number of Participants With Frequency of MA-OM Events
MA OM: >3
|
4 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From first year through 3 yearsPopulation: The ITT population included all participants in the treatment group according to their randomized treatment group. Here, "number analyzed" signified, only those participants who were analyzed from first year through 3 years.
Wheezing events were included in the analysis of medically-attended wheezing, if the medical care provider documented wheezing in the medical record or records as a discharge diagnosis any of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode was recorded as one that occurred \>2 weeks after the diagnosis of the previous episode and the medical opinion was that the wheezing does not represent a persistence of the previous episode. Number of participants with greater than or equal to (\>=) 1 MA wheezing events and \>= 3 MA wheezing events occurring from first through 3 years of age are reported.
Outcome measures
| Measure |
Placebo
n=641 Participants
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
Motavizumab
n=1278 Participants
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Number of Participants With Medically Attended Wheezing Episodes
>= 1 MA wheezing events
|
179 Participants
|
342 Participants
|
|
Number of Participants With Medically Attended Wheezing Episodes
>= 3 MA wheezing events
|
16 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: From first year through 3 yearsPopulation: The ITT population included all participants in the treatment group according to their randomized treatment group. Here, "number analyzed" signified, only those participants who were analyzed from first year through 3 years.
Serious early childhood wheezing (SECW) was defined as: three or more medically attended wheezing events over a 12 month period occurring any time from the first through the third birthday, or a need for one or more courses of systemic steroids for a treatment of a medically attended wheezing event from the first through the third birthday, or a need for asthma-controller medication over a 12 month period for at least 3 consecutive months (\>= 90 days) or 5 cumulative months (\>= 150 days) any time from the first through the third birthday, or at least one inpatient wheezing event from the first through the third birthday.
Outcome measures
| Measure |
Placebo
n=641 Participants
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
Motavizumab
n=1278 Participants
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Number of Participants With Serious Early Childhood Wheezing Episodes
SECW
|
90 Participants
|
190 Participants
|
|
Number of Participants With Serious Early Childhood Wheezing Episodes
Three or more MA wheezing events over a 12 month period
|
16 Participants
|
35 Participants
|
|
Number of Participants With Serious Early Childhood Wheezing Episodes
Need of systemic steroids for a MA wheezing event
|
66 Participants
|
144 Participants
|
|
Number of Participants With Serious Early Childhood Wheezing Episodes
Asthma-controller medication for wheezing over a 12 month period
|
2 Participants
|
11 Participants
|
|
Number of Participants With Serious Early Childhood Wheezing Episodes
>= 1 hospitalization with MA wheezing
|
47 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: Study Day 0 through 3 yearsPopulation: The ITT population included all participants in the treatment group according to their randomized treatment group.
Wheezing events were included in the analysis of medically-attended wheezing, if the medical care provider documented wheezing in the medical record or records as a discharge diagnosis any of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode was recorded as one that occurred \>2 weeks after the diagnosis of the previous episode and the medical opinion is that the wheezing does not represent a persistence of the previous episode. Number of participants with frequency of MA wheezing events (either 0, 1, 2, 3, 4, or greater than or equal to \[\>=\] 5) are reported.
Outcome measures
| Measure |
Placebo
n=710 Participants
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
Motavizumab
n=1417 Participants
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Number of Participants With Frequency of Medically Attended Wheezing Events
0 events
|
384 Participants
|
908 Participants
|
|
Number of Participants With Frequency of Medically Attended Wheezing Events
1 event
|
182 Participants
|
288 Participants
|
|
Number of Participants With Frequency of Medically Attended Wheezing Events
2 events
|
72 Participants
|
109 Participants
|
|
Number of Participants With Frequency of Medically Attended Wheezing Events
3 events
|
34 Participants
|
44 Participants
|
|
Number of Participants With Frequency of Medically Attended Wheezing Events
4 events
|
18 Participants
|
27 Participants
|
|
Number of Participants With Frequency of Medically Attended Wheezing Events
>= 5 events
|
20 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Day 0 (pre Dose 1) and Day 120 (Pre Dose 5)Population: Pharmacokinetics (PK) population included all participants (in seasons 1 through 3) who received at least 4 doses of motavizumab and had a post-baseline PK measurement available. Here, number analyzed signified only those participants who had adequate PK samples at the specified time points.
The mean trough serum concentrations of motavizumab are reported.
Outcome measures
| Measure |
Placebo
n=509 Participants
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
Motavizumab
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Mean Trough Serum Concentrations of Motavizumab
Day 0 (Pre dose 1)
|
0.003212 μg/mL
Standard Deviation 0.07147
|
—
|
|
Mean Trough Serum Concentrations of Motavizumab
Day 120 (pre dose 5)
|
86.46 μg/mL
Standard Deviation 31.77
|
—
|
SECONDARY outcome
Timeframe: Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5)Population: Evaluable population for full dose included all participants (in season 1 through 3) who received 4 doses of motavizumab prior to ADA sample collection, and had Day 120 ADA data available. Here, number analyzed signified only those participants who had adequate ADA samples at the specified time points.
The number of participants with positive serum antidrug antibodies (ADAs) to motavizumab after full dose are reported.
Outcome measures
| Measure |
Placebo
n=665 Participants
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
Motavizumab
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Number of Participants With Positive Anti-Motavizumab Antibodies After Full Dose
Day 0 (Pre Dose 1)
|
0 Participants
|
—
|
|
Number of Participants With Positive Anti-Motavizumab Antibodies After Full Dose
Day 120 (Pre Dose 5)
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5)Population: Evaluable population for any dose included all participants (in season 1 through 3) who received at least 1 dose of motavizumab prior to ADA sample collection, and had Day 120 ADA data available. Here, number analyzed signified only those participants who had adequate ADA samples at the specified timepoints.
The number of participants with positive serum ADA to motavizumab after any dose are reported.
Outcome measures
| Measure |
Placebo
n=717 Participants
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
Motavizumab
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Number of Participants With Positive Anti-Motavizumab Antibodies After Any Dose
Day 0 (Pre Dose 1)
|
0 Participants
|
—
|
|
Number of Participants With Positive Anti-Motavizumab Antibodies After Any Dose
Day 120 (Pre Dose 5)
|
3 Participants
|
—
|
Adverse Events
PLACEBO
Serious events: 148 serious events
Other events: 682 other events
Deaths: 5 deaths
MOTAVIZUMAB
Serious events: 212 serious events
Other events: 1345 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
PLACEBO
n=708 participants at risk
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
MOTAVIZUMAB
n=1414 participants at risk
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Benign familial neonatal convulsions
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Congenital, familial and genetic disorders
Combined immunodeficiency
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Congenital, familial and genetic disorders
Fallot's tetralogy
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Congenital, familial and genetic disorders
Microvillous inclusion disease
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.00%
0/1414 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.14%
2/1414 • Number of events 2 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
General disorders
Fever neonatal
|
0.56%
4/708 • Number of events 4 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.71%
10/1414 • Number of events 11 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
General disorders
Pyrexia
|
0.42%
3/708 • Number of events 3 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.57%
8/1414 • Number of events 8 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.85%
6/708 • Number of events 6 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.71%
10/1414 • Number of events 11 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia neonatal
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.00%
0/1414 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Hepatobiliary disorders
Jaundice
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.28%
4/1414 • Number of events 4 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Immune system disorders
Milk allergy
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.42%
3/708 • Number of events 3 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.21%
3/1414 • Number of events 3 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Bronchiolitis
|
4.9%
35/708 • Number of events 36 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
2.1%
29/1414 • Number of events 32 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Bronchitis
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.21%
3/1414 • Number of events 3 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.14%
2/1414 • Number of events 2 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Croup infectious
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.14%
2/1414 • Number of events 2 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.14%
2/1414 • Number of events 2 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
14/708 • Number of events 14 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
2.2%
31/1414 • Number of events 32 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.21%
3/1414 • Number of events 3 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.35%
5/1414 • Number of events 5 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Groin abscess
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.00%
0/1414 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Influenza
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.21%
3/1414 • Number of events 3 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Lobar pneumonia
|
0.42%
3/708 • Number of events 3 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.35%
5/1414 • Number of events 5 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.56%
4/708 • Number of events 4 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.57%
8/1414 • Number of events 9 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.00%
0/1414 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Meningitis candida
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Meningitis pneumococcal
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Pneumonia
|
2.8%
20/708 • Number of events 21 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
2.5%
36/1414 • Number of events 39 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.00%
0/1414 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.14%
2/1414 • Number of events 2 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Pneumonia influenzal
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.21%
3/1414 • Number of events 3 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.85%
6/708 • Number of events 6 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.28%
2/708 • Number of events 2 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.28%
4/1414 • Number of events 4 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
5.4%
38/708 • Number of events 39 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.1%
16/1414 • Number of events 17 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.56%
4/708 • Number of events 5 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.21%
3/1414 • Number of events 3 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.50%
7/1414 • Number of events 7 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.21%
3/1414 • Number of events 3 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Viral infection
|
0.85%
6/708 • Number of events 6 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.35%
5/1414 • Number of events 5 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.21%
3/1414 • Number of events 3 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.14%
2/1414 • Number of events 2 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Investigations
Bacterial test
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Investigations
Blood culture positive
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.00%
0/1414 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Investigations
Laboratory test interference
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.00%
0/1414 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Investigations
Medical observation
|
0.28%
2/708 • Number of events 2 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.00%
0/1414 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.14%
2/1414 • Number of events 2 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.28%
2/708 • Number of events 2 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Craniosynostosis
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Synostosis
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Nervous system disorders
Convulsion
|
0.28%
2/708 • Number of events 2 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.35%
5/1414 • Number of events 5 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Nervous system disorders
Dyskinesia
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.00%
0/1414 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Nervous system disorders
Febrile convulsion
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Nervous system disorders
Subdural hygroma
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.14%
1/708 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.00%
0/1414 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.21%
3/1414 • Number of events 4 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.28%
2/708 • Number of events 2 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.00%
0/1414 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.42%
3/708 • Number of events 3 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.14%
2/1414 • Number of events 2 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Social circumstances
Victim of child abuse
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/708 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.07%
1/1414 • Number of events 1 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
Other adverse events
| Measure |
PLACEBO
n=708 participants at risk
Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
|
MOTAVIZUMAB
n=1414 participants at risk
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Dacryostenosis congenital
|
0.56%
4/708 • Number of events 4 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.6%
23/1414 • Number of events 24 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
5.5%
39/708 • Number of events 40 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
5.7%
81/1414 • Number of events 94 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
1.1%
8/708 • Number of events 8 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.7%
24/1414 • Number of events 24 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Eye disorders
Conjunctivitis
|
19.2%
136/708 • Number of events 152 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
19.2%
271/1414 • Number of events 303 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Eye disorders
Eye discharge
|
1.7%
12/708 • Number of events 12 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.5%
21/1414 • Number of events 21 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
13/708 • Number of events 13 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.8%
26/1414 • Number of events 26 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Gastrointestinal disorders
Constipation
|
8.1%
57/708 • Number of events 61 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
6.9%
97/1414 • Number of events 107 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
106/708 • Number of events 130 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
13.9%
196/1414 • Number of events 230 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.56%
4/708 • Number of events 4 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.2%
17/1414 • Number of events 17 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
10/708 • Number of events 10 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.3%
19/1414 • Number of events 19 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Gastrointestinal disorders
Teething
|
12.1%
86/708 • Number of events 96 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
11.8%
167/1414 • Number of events 178 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
22/708 • Number of events 23 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
3.5%
49/1414 • Number of events 50 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
General disorders
Irritability
|
2.7%
19/708 • Number of events 20 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
2.3%
33/1414 • Number of events 33 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
General disorders
Pyrexia
|
22.6%
160/708 • Number of events 193 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
21.7%
307/1414 • Number of events 364 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Hepatobiliary disorders
Jaundice
|
4.4%
31/708 • Number of events 31 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
3.2%
45/1414 • Number of events 46 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Bronchiolitis
|
12.3%
87/708 • Number of events 98 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
9.3%
132/1414 • Number of events 146 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Bronchitis
|
0.85%
6/708 • Number of events 8 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.3%
19/1414 • Number of events 20 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Candida nappy rash
|
4.2%
30/708 • Number of events 30 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
3.7%
52/1414 • Number of events 54 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Croup infectious
|
1.4%
10/708 • Number of events 10 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.9%
27/1414 • Number of events 28 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Gastroenteritis
|
16.0%
113/708 • Number of events 128 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
13.9%
196/1414 • Number of events 223 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
1.4%
10/708 • Number of events 12 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.6%
22/1414 • Number of events 24 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Impetigo
|
1.3%
9/708 • Number of events 9 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.1%
16/1414 • Number of events 17 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Lobar pneumonia
|
1.4%
10/708 • Number of events 11 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.99%
14/1414 • Number of events 14 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
7.5%
53/708 • Number of events 58 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
4.7%
66/1414 • Number of events 70 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
14/708 • Number of events 14 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
2.7%
38/1414 • Number of events 42 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Oral candidiasis
|
9.9%
70/708 • Number of events 75 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
8.3%
118/1414 • Number of events 128 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Otitis externa
|
0.42%
3/708 • Number of events 3 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.3%
19/1414 • Number of events 19 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Otitis media
|
37.9%
268/708 • Number of events 381 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
36.9%
522/1414 • Number of events 742 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Otitis media acute
|
1.4%
10/708 • Number of events 10 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.2%
17/1414 • Number of events 17 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Pneumonia
|
6.4%
45/708 • Number of events 50 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
6.9%
97/1414 • Number of events 103 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Respiratory tract infection viral
|
2.4%
17/708 • Number of events 17 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
2.1%
30/1414 • Number of events 32 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Skin candida
|
1.6%
11/708 • Number of events 11 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.4%
20/1414 • Number of events 21 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
64.8%
459/708 • Number of events 747 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
63.9%
903/1414 • Number of events 1560 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.5%
18/708 • Number of events 18 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.6%
22/1414 • Number of events 26 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Viral infection
|
11.3%
80/708 • Number of events 98 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
12.4%
175/1414 • Number of events 217 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Viral skin infection
|
2.1%
15/708 • Number of events 15 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
2.2%
31/1414 • Number of events 32 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.5%
32/708 • Number of events 33 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
5.4%
76/1414 • Number of events 78 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Investigations
Cardiac murmur
|
1.7%
12/708 • Number of events 12 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
2.5%
35/1414 • Number of events 35 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
10/708 • Number of events 11 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.3%
18/1414 • Number of events 18 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
1.7%
12/708 • Number of events 13 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.3%
18/1414 • Number of events 19 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.2%
65/708 • Number of events 70 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
10.5%
149/1414 • Number of events 171 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.8%
55/708 • Number of events 58 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
9.1%
128/1414 • Number of events 140 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
6.6%
47/708 • Number of events 49 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
6.6%
93/1414 • Number of events 104 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
71/708 • Number of events 77 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
8.3%
118/1414 • Number of events 123 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.8%
20/708 • Number of events 21 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
2.8%
39/1414 • Number of events 39 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
3.0%
21/708 • Number of events 23 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.7%
24/1414 • Number of events 26 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.7%
12/708 • Number of events 12 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.3%
18/1414 • Number of events 18 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
21.0%
149/708 • Number of events 183 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
21.1%
298/1414 • Number of events 359 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.0%
21/708 • Number of events 22 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
2.8%
39/1414 • Number of events 40 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.8%
55/708 • Number of events 62 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
5.7%
80/1414 • Number of events 87 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
56/708 • Number of events 61 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
9.5%
135/1414 • Number of events 146 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.42%
3/708 • Number of events 3 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.3%
18/1414 • Number of events 18 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
2.5%
18/708 • Number of events 18 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
3.2%
45/1414 • Number of events 47 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.71%
5/708 • Number of events 5 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.1%
15/1414 • Number of events 16 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
1.1%
8/708 • Number of events 8 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.57%
8/1414 • Number of events 8 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.4%
10/708 • Number of events 10 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.71%
10/1414 • Number of events 10 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Infections and infestations
Rhinitis
|
1.1%
8/708 • Number of events 8 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.57%
8/1414 • Number of events 8 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.56%
4/708 • Number of events 4 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
1.1%
15/1414 • Number of events 16 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
1.1%
8/708 • Number of events 8 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
0.78%
11/1414 • Number of events 12 • From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it is understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER