Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. (NCT NCT02878330)
NCT ID: NCT02878330
Last Updated: 2019-10-14
Results Overview
The determination of medically attended RSV LRTI is based on objective clinical LRTI criteria and RSV test results obtained from analyzing the respiratory secretions using a validated RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the detection of RSV A or RSV B subtypes. Criteria for LRTI included documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of the following: increased respiratory rate at rest (for age less than (\<) 2 months: greater than or equal to (\>=) 60 breaths/min; 2-6 months: \>= 50 breaths/min; and for \> 6 months - 2 years, \>= 40 breaths/min), or hypoxemia (in room air - oxygen saturation \< 95% at altitudes less than or equal to (\<=) 1800 meters or \< 92% at altitudes \> 1800 meters), or clinical signs of severe respiratory disease or dehydration secondary to inadequate oral intake due to respiratory distress (need for intravenous fluid).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1453 participants
Primary outcome timeframe
From Day 1 through Day 151
Results posted on
2019-10-14
Participant Flow
The study was conducted from 03-Nov-2016 to 06-Dec-2018.
A total of 1540 participants were screened, out of which 1453 participants were randomized in the study.
Participant milestones
| Measure |
Placebo
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
|
MEDI8897 50 mg
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
484
|
969
|
|
Overall Study
COMPLETED
|
455
|
913
|
|
Overall Study
NOT COMPLETED
|
29
|
56
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
|
MEDI8897 50 mg
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
|
|---|---|---|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
11
|
26
|
|
Overall Study
Withdrawal by Subject
|
11
|
21
|
|
Overall Study
Other
|
4
|
7
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
Baseline characteristics by cohort
| Measure |
Placebo
n=484 Participants
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
|
MEDI8897 50 mg
n=969 Participants
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
|
Total
n=1453 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.28 Months
STANDARD_DEVIATION 2.31 • n=5 Participants
|
3.29 Months
STANDARD_DEVIATION 2.22 • n=7 Participants
|
3.29 Months
STANDARD_DEVIATION 2.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
224 Participants
n=5 Participants
|
468 Participants
n=7 Participants
|
692 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
260 Participants
n=5 Participants
|
501 Participants
n=7 Participants
|
761 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
91 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
316 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
393 Participants
n=5 Participants
|
743 Participants
n=7 Participants
|
1136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
67 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
355 Participants
n=5 Participants
|
693 Participants
n=7 Participants
|
1048 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
43 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 through Day 151Population: The ITT population included all participants who were randomized in the study and analyzed according to their randomized treatment group.
The determination of medically attended RSV LRTI is based on objective clinical LRTI criteria and RSV test results obtained from analyzing the respiratory secretions using a validated RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the detection of RSV A or RSV B subtypes. Criteria for LRTI included documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of the following: increased respiratory rate at rest (for age less than (\<) 2 months: greater than or equal to (\>=) 60 breaths/min; 2-6 months: \>= 50 breaths/min; and for \> 6 months - 2 years, \>= 40 breaths/min), or hypoxemia (in room air - oxygen saturation \< 95% at altitudes less than or equal to (\<=) 1800 meters or \< 92% at altitudes \> 1800 meters), or clinical signs of severe respiratory disease or dehydration secondary to inadequate oral intake due to respiratory distress (need for intravenous fluid).
Outcome measures
| Measure |
Placebo
n=484 Participants
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
|
MEDI8897 50 mg
n=969 Participants
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
|
|---|---|---|
|
Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)
|
46 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: From Day 1 through Day 151Population: The ITT population included all participants who were randomized in the study and analyzed according to their randomized treatment group.
A RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive RSV test within 2 days of hospitalization (primary) or 2) new onset of respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial).
Outcome measures
| Measure |
Placebo
n=484 Participants
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
|
MEDI8897 50 mg
n=969 Participants
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
|
|---|---|---|
|
Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI)
|
20 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From Day 1 through Day 361Population: As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. 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=479 Participants
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
|
MEDI8897 50 mg
n=968 Participants
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs
|
416 Participants
|
834 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TESAEs
|
81 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: From Day 1 through Day 361Population: As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
An AESI was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. An AESI may be serious or non-serious. A NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving study drug and is assessed by investigator as medically significant.
Outcome measures
| Measure |
Placebo
n=479 Participants
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
|
MEDI8897 50 mg
n=968 Participants
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
|
|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)
AESIs
|
3 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)
NOCDs
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Days 91, 151, and 361Population: As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
Outcome measures
| Measure |
Placebo
n=968 Participants
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
|
MEDI8897 50 mg
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
|
|---|---|---|
|
Serum Concentration of MEDI8897
Day 91
|
35.9 mcg/mL
Standard Deviation 10.9
|
—
|
|
Serum Concentration of MEDI8897
Day 151
|
18.9 mcg/mL
Standard Deviation 7.4
|
—
|
|
Serum Concentration of MEDI8897
Day 361
|
2.1 mcg/mL
Standard Deviation 1.1
|
—
|
SECONDARY outcome
Timeframe: Day 91 through Day 361Population: As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received. Participants with sufficient additional pharmacokinetics (PK) samples from unscheduled visits were analysed for this outcome measure.
Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the serum.
Outcome measures
| Measure |
Placebo
n=968 Participants
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
|
MEDI8897 50 mg
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
|
|---|---|---|
|
Elimination Half-life (t1/2) of MEDI8897
|
59.3 Days
Standard Deviation 9.6
|
—
|
SECONDARY outcome
Timeframe: Days 91, 151, and 361Population: As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
The number of participants with positive serum antibodies to MEDI8897 are reported.
Outcome measures
| Measure |
Placebo
n=479 Participants
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
|
MEDI8897 50 mg
n=968 Participants
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
|
|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies to MEDI8897
Day 91
|
4 Participants
|
11 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies to MEDI8897
Day 151
|
6 Participants
|
17 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies to MEDI8897
Day 361
|
8 Participants
|
30 Participants
|
Adverse Events
Placebo
Serious events: 81 serious events
Other events: 402 other events
Deaths: 3 deaths
MEDI8897 50 mg
Serious events: 108 serious events
Other events: 804 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=479 participants at risk
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
|
MEDI8897 50 mg
n=968 participants at risk
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 3 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Cardiac disorders
Myocarditis
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Cardiac disorders
Pericardial effusion
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Congenital, familial and genetic disorders
Muscular dystrophy
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.21%
2/968 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Enteritis
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.3%
6/479 • Number of events 6 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.21%
2/968 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
General disorders
Death
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
General disorders
Pyrexia
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.31%
3/968 • Number of events 3 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Adenovirus infection
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Bronchiolitis
|
4.4%
21/479 • Number of events 26 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
2.1%
20/968 • Number of events 22 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Bronchitis
|
2.3%
11/479 • Number of events 11 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.4%
14/968 • Number of events 16 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.21%
2/968 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Gastroenteritis
|
0.84%
4/479 • Number of events 5 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.93%
9/968 • Number of events 9 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Gastroenteritis escherichia coli
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.42%
2/479 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Gastroenteritis viral
|
0.21%
1/479 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Influenza
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.7%
13/479 • Number of events 18 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.4%
14/968 • Number of events 14 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.63%
3/479 • Number of events 5 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.52%
5/968 • Number of events 5 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Meningitis
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Meningitis bacterial
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Otitis media
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.21%
2/968 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Peritonsillar abscess
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Pneumonia
|
2.1%
10/479 • Number of events 12 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.3%
13/968 • Number of events 13 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Pneumonia bacterial
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.42%
2/479 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.21%
2/968 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Pneumonia viral
|
0.42%
2/479 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.72%
7/968 • Number of events 8 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.42%
2/479 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Sepsis
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.21%
2/968 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Staphylococcal scalded skin syndrome
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.63%
3/479 • Number of events 3 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.31%
3/968 • Number of events 3 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Urinary tract infection
|
0.84%
4/479 • Number of events 5 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Injury, poisoning and procedural complications
Palate injury
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.21%
2/968 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.21%
2/968 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eyelid haemangioma
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Nervous system disorders
Hypotonia
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Nervous system disorders
Infantile spasms
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Nervous system disorders
Seizure
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Psychiatric disorders
Irritability
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.21%
2/968 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Reproductive system and breast disorders
Penile adhesion
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.21%
2/968 • Number of events 2 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary vein stenosis
|
0.00%
0/479 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.10%
1/968 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.21%
1/479 • Number of events 1 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.00%
0/968 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
Other adverse events
| Measure |
Placebo
n=479 participants at risk
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
|
MEDI8897 50 mg
n=968 participants at risk
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.5%
17/479 • Number of events 17 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
3.0%
29/968 • Number of events 29 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Congenital, familial and genetic disorders
Plagiocephaly
|
0.63%
3/479 • Number of events 3 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.5%
15/968 • Number of events 15 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
10/479 • Number of events 10 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.52%
5/968 • Number of events 5 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Constipation
|
4.4%
21/479 • Number of events 24 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
3.5%
34/968 • Number of events 36 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.2%
49/479 • Number of events 55 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
10.1%
98/968 • Number of events 113 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.6%
22/479 • Number of events 22 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
3.8%
37/968 • Number of events 38 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Teething
|
6.7%
32/479 • Number of events 35 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
6.4%
62/968 • Number of events 72 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.63%
3/479 • Number of events 3 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.1%
11/968 • Number of events 11 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
15/479 • Number of events 17 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
4.1%
40/968 • Number of events 46 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
General disorders
Pyrexia
|
13.2%
63/479 • Number of events 75 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
11.3%
109/968 • Number of events 133 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Acarodermatitis
|
1.7%
8/479 • Number of events 8 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.3%
13/968 • Number of events 15 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Bronchiolitis
|
8.8%
42/479 • Number of events 60 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
8.6%
83/968 • Number of events 104 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Bronchitis
|
10.2%
49/479 • Number of events 77 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
9.4%
91/968 • Number of events 150 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Candida nappy rash
|
1.3%
6/479 • Number of events 6 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.2%
12/968 • Number of events 14 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Conjunctivitis
|
8.1%
39/479 • Number of events 44 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
8.9%
86/968 • Number of events 94 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Croup infectious
|
1.3%
6/479 • Number of events 7 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.2%
12/968 • Number of events 13 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Ear infection
|
2.7%
13/479 • Number of events 21 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
2.4%
23/968 • Number of events 34 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Exanthema subitum
|
2.3%
11/479 • Number of events 11 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
2.2%
21/968 • Number of events 22 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Fungal skin infection
|
1.7%
8/479 • Number of events 8 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.52%
5/968 • Number of events 5 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Gastroenteritis
|
9.2%
44/479 • Number of events 49 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
11.9%
115/968 • Number of events 138 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Gastroenteritis viral
|
1.0%
5/479 • Number of events 5 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.3%
13/968 • Number of events 15 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
2.9%
14/479 • Number of events 14 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
3.7%
36/968 • Number of events 36 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Impetigo
|
1.3%
6/479 • Number of events 6 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.2%
12/968 • Number of events 12 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Laryngitis
|
2.1%
10/479 • Number of events 10 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
2.5%
24/968 • Number of events 31 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Lower respiratory tract infection
|
9.6%
46/479 • Number of events 65 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
7.7%
75/968 • Number of events 103 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
1.3%
6/479 • Number of events 8 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
0.93%
9/968 • Number of events 9 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
19.6%
94/479 • Number of events 158 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
16.9%
164/968 • Number of events 264 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Oral candidiasis
|
5.4%
26/479 • Number of events 26 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
3.7%
36/968 • Number of events 39 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Otitis media
|
8.8%
42/479 • Number of events 63 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
6.5%
63/968 • Number of events 87 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Otitis media acute
|
5.0%
24/479 • Number of events 33 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
5.3%
51/968 • Number of events 82 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Pharyngitis
|
5.6%
27/479 • Number of events 32 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
5.9%
57/968 • Number of events 68 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Rhinitis
|
10.4%
50/479 • Number of events 61 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
11.5%
111/968 • Number of events 145 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Tonsillitis
|
1.0%
5/479 • Number of events 6 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.7%
16/968 • Number of events 16 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
35.3%
169/479 • Number of events 337 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
40.5%
392/968 • Number of events 734 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
7/479 • Number of events 7 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.2%
12/968 • Number of events 12 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Varicella
|
2.3%
11/479 • Number of events 11 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
2.0%
19/968 • Number of events 19 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Viral rash
|
3.1%
15/479 • Number of events 16 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
3.3%
32/968 • Number of events 34 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.1%
34/479 • Number of events 57 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
5.0%
48/968 • Number of events 75 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.3%
6/479 • Number of events 6 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.4%
14/968 • Number of events 14 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
3.1%
15/479 • Number of events 19 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
2.4%
23/968 • Number of events 28 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Psychiatric disorders
Irritability
|
1.5%
7/479 • Number of events 14 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.1%
11/968 • Number of events 20 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
15/479 • Number of events 17 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
3.8%
37/968 • Number of events 45 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
24/479 • Number of events 27 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
7.3%
71/968 • Number of events 83 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
3.5%
17/479 • Number of events 17 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
2.4%
23/968 • Number of events 23 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.1%
29/479 • Number of events 34 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
6.5%
63/968 • Number of events 75 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.1%
15/479 • Number of events 15 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
2.1%
20/968 • Number of events 26 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.7%
8/479 • Number of events 9 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
3.1%
30/968 • Number of events 34 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
7.5%
36/479 • Number of events 44 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
7.9%
76/968 • Number of events 94 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.1%
15/479 • Number of events 15 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
3.5%
34/968 • Number of events 34 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.5%
17/479 • Number of events 18 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
4.4%
43/968 • Number of events 49 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.5%
7/479 • Number of events 8 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
1.8%
17/968 • Number of events 17 • From Day 1 through Day 361
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
|
Additional Information
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 on going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER