Trial Outcomes & Findings for Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection (NCT NCT03656510)

Last Updated: 2025-02-04

Results Overview

RSV viral load AUC from immediately prior to first dose of study drug through Day 5 was determined. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens. As planned, combined data for both the cohorts was collected, analyzed and reported for this outcome measure.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

246 participants

Primary outcome timeframe

Baseline through Day 5

Results posted on

2025-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: Placebo Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 Low Dose Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Overall Study STARTED	50	49	48	34	34	31
Overall Study COMPLETED	48	48	48	33	34	31
Overall Study NOT COMPLETED	2	1	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Placebo Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 Low Dose Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Overall Study Lost to Follow-up	1	0	0	0	0	0
Overall Study Withdrawal by Subject	1	1	0	1	0	0

Baseline Characteristics

Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Placebo n=50 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 Low Dose n=49 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.	Total n=246 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	10 Participants n=8 Participants
Age, Continuous	8.4 months STANDARD_DEVIATION 8.59 • n=5 Participants	8.6 months STANDARD_DEVIATION 8.74 • n=7 Participants	8.5 months STANDARD_DEVIATION 8.21 • n=5 Participants	13.8 months STANDARD_DEVIATION 10.31 • n=4 Participants	14.8 months STANDARD_DEVIATION 10.9 • n=21 Participants	17.2 months STANDARD_DEVIATION 8.81 • n=8 Participants	11.2 months STANDARD_DEVIATION 9.71 • n=8 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants	13 Participants n=4 Participants	8 Participants n=21 Participants	14 Participants n=8 Participants	101 Participants n=8 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	29 Participants n=7 Participants	25 Participants n=5 Participants	21 Participants n=4 Participants	26 Participants n=21 Participants	17 Participants n=8 Participants	145 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	19 Participants n=7 Participants	21 Participants n=5 Participants	10 Participants n=4 Participants	9 Participants n=21 Participants	10 Participants n=8 Participants	87 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	28 Participants n=7 Participants	24 Participants n=5 Participants	24 Participants n=4 Participants	25 Participants n=21 Participants	21 Participants n=8 Participants	151 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	8 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	5 Participants n=8 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	14 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	14 Participants n=21 Participants	13 Participants n=8 Participants	78 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	5 Participants n=8 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	29 Participants n=7 Participants	31 Participants n=5 Participants	22 Participants n=4 Participants	19 Participants n=21 Participants	18 Participants n=8 Participants	147 Participants n=8 Participants
Region of Enrollment ARGENTINA	5 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	16 Participants n=8 Participants
Region of Enrollment BRAZIL	1 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=8 Participants	26 Participants n=8 Participants
Region of Enrollment BULGARIA	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	7 Participants n=8 Participants	24 Participants n=8 Participants
Region of Enrollment GERMANY	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Region of Enrollment HUNGARY	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	13 Participants n=8 Participants
Region of Enrollment ITALY	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Region of Enrollment JAPAN	5 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants	12 Participants n=21 Participants	7 Participants n=8 Participants	39 Participants n=8 Participants
Region of Enrollment MALAYSIA	4 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	12 Participants n=8 Participants
Region of Enrollment MEXICO	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants
Region of Enrollment POLAND	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Region of Enrollment RUSSIAN FEDERATION	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Region of Enrollment SOUTH AFRICA	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Region of Enrollment SOUTH KOREA	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Region of Enrollment SPAIN	17 Participants n=5 Participants	17 Participants n=7 Participants	20 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	65 Participants n=8 Participants
Region of Enrollment SWEDEN	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Region of Enrollment TAIWAN	3 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	12 Participants n=8 Participants
Region of Enrollment THAILAND	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	10 Participants n=8 Participants
Region of Enrollment TURKEY	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Region of Enrollment UNITED KINGDOM	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Region of Enrollment UNITED STATES	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline through Day 5

Population: Intent-to-Treat-infected (ITT-i) analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV RNA viral load of greater than or equal to (\>=) 1 log10 copies/mL above the lower limit of quantification (LLOQ) of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=80 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=79 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=72 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 (AUC[Day 5])	21.48 log10 copies*day per milliliter (mL) Interval 20.402 to 22.566	22.74 log10 copies*day per milliliter (mL) Interval 21.677 to 23.8	21.51 log10 copies*day per milliliter (mL) Interval 20.374 to 22.65	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 3, 5, 8, 14, and 21

Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'n' (number analyzed) represents number of participants who were evaluable at specified timepoints.

RSV viral load actual values over time were measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home. As planned, combined data for both the cohorts was collected, analyzed and reported for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=80 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=79 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=72 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
RSV Viral Load Over Time Day 21	0.817 log10 copies/mL Standard Deviation 1.5347	1.150 log10 copies/mL Standard Deviation 1.7752	0.810 log10 copies/mL Standard Deviation 1.6699	—	—	—
RSV Viral Load Over Time Baseline	7.113 log10 copies/mL Standard Deviation 1.3667	6.913 log10 copies/mL Standard Deviation 1.3449	7.004 log10 copies/mL Standard Deviation 1.4709	—	—	—
RSV Viral Load Over Time Day 3	5.432 log10 copies/mL Standard Deviation 1.8952	5.398 log10 copies/mL Standard Deviation 1.5834	5.271 log10 copies/mL Standard Deviation 1.7710	—	—	—
RSV Viral Load Over Time Day 5	4.079 log10 copies/mL Standard Deviation 1.8760	4.146 log10 copies/mL Standard Deviation 1.8508	3.883 log10 copies/mL Standard Deviation 1.9815	—	—	—
RSV Viral Load Over Time Day 8	2.108 log10 copies/mL Standard Deviation 1.8538	2.604 log10 copies/mL Standard Deviation 2.0857	2.078 log10 copies/mL Standard Deviation 1.8319	—	—	—
RSV Viral Load Over Time Day 14	1.636 log10 copies/mL Standard Deviation 2.2221	1.640 log10 copies/mL Standard Deviation 1.9515	1.440 log10 copies/mL Standard Deviation 1.8768	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Days 3, 5, 8, 14, and 21

Change from baseline in RSV viral load over time was measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home. As planned, combined data for both the cohorts was collected, analyzed and reported for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=80 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=79 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=72 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Change From Baseline in RSV Viral Load Over Time Day 3	-1.690 log10 copies/mL Standard Deviation 1.6225	-1.502 log10 copies/mL Standard Deviation 1.3290	-1.694 log10 copies/mL Standard Deviation 1.5134	—	—	—
Change From Baseline in RSV Viral Load Over Time Day 14	-5.471 log10 copies/mL Standard Deviation 2.4289	-5.292 log10 copies/mL Standard Deviation 2.2968	-5.578 log10 copies/mL Standard Deviation 2.2707	—	—	—
Change From Baseline in RSV Viral Load Over Time Day 5	-3.049 log10 copies/mL Standard Deviation 1.6493	-2.754 log10 copies/mL Standard Deviation 1.7699	-3.121 log10 copies/mL Standard Deviation 1.8453	—	—	—
Change From Baseline in RSV Viral Load Over Time Day 8	-5.017 log10 copies/mL Standard Deviation 1.8563	-4.308 log10 copies/mL Standard Deviation 2.2435	-4.948 log10 copies/mL Standard Deviation 1.8428	—	—	—
Change From Baseline in RSV Viral Load Over Time Day 21	-6.302 log10 copies/mL Standard Deviation 2.0439	-5.801 log10 copies/mL Standard Deviation 2.1652	-6.268 log10 copies/mL Standard Deviation 1.9394	—	—	—

SECONDARY outcome

Timeframe: Baseline through Days 3, 8, and 14

LS mean RSV viral load on Days 3, 8, and 14 was reported. LS mean viral load (log10 copies/mL) was estimated per time point. The difference in RSV viral Load AUC (log10 copies\*day/mL) from immediately prior to first dose of study drug (baseline) through Day 3, 8 and 14 was determined from the model estimating the LS Mean Viral Load per time point, and is presented in the statistical analysis. The RSV viral load was measured by qRT-PCR assay in mid-turbinate nasal swab specimens. As planned, combined data for both the cohorts was collected, and analyzed for this outcome measure at Days 3 and 8, however combined Cohort 1 and Cohort 2 data were not analyzed for this outcome measure at Day 14, due to the premature study termination.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=80 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=79 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=72 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Least Squares (LS) Mean RSV Viral Load on Days 3, 8 and 14 Day 3: LS means RSV Viral Load	5.36 log10 copies*day/mL Interval 5.009 to 5.717	5.48 log10 copies*day/mL Interval 5.129 to 5.834	5.32 log10 copies*day/mL Interval 4.949 to 5.695	—	—	—
Least Squares (LS) Mean RSV Viral Load on Days 3, 8 and 14 Day 8: LS means RSV Viral Load	2.08 log10 copies*day/mL Interval 1.716 to 2.444	2.66 log10 copies*day/mL Interval 2.307 to 3.011	2.08 log10 copies*day/mL Interval 1.701 to 2.45	—	—	—

SECONDARY outcome

Timeframe: Up to Day 21

Time to undetectable RSV viral load (as measured by qRT-PCR) was defined as the time in hours from first dose of study drug to first post-baseline timepoint at which the virus was undetectable and after which there were no more detectable virus assessments. As planned, combined data for both the cohorts was collected, analyzed and reported for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=80 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=79 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=72 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Time to Undetectable RSV Viral Load	428.3 Hours Interval 309.5 to 480.4	467.0 Hours Interval 332.9 to 478.4	330.7 Hours Interval 308.28 to 476.0	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 3, 5, 8, 14 and 21

Percentage of participants with undetectable RSV viral load (as measured by qRT-PCR) at each timepoint throughout the study was reported. As planned, combined data for both the cohorts were collected, analyzed and reported for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=80 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=79 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=72 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Percentage of Participants With Undetectable RSV Viral Load at Each Timepoint Throughout the Study Day 14	58.1 Percentage of participants	54.8 Percentage of participants	58.2 Percentage of participants	—	—	—
Percentage of Participants With Undetectable RSV Viral Load at Each Timepoint Throughout the Study Day 21	76.9 Percentage of participants	67.6 Percentage of participants	77.9 Percentage of participants	—	—	—
Percentage of Participants With Undetectable RSV Viral Load at Each Timepoint Throughout the Study Baseline	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	—	—
Percentage of Participants With Undetectable RSV Viral Load at Each Timepoint Throughout the Study Day 3	3.8 Percentage of participants	1.3 Percentage of participants	2.8 Percentage of participants	—	—	—
Percentage of Participants With Undetectable RSV Viral Load at Each Timepoint Throughout the Study Day 5	9.1 Percentage of participants	7.8 Percentage of participants	11.1 Percentage of participants	—	—	—
Percentage of Participants With Undetectable RSV Viral Load at Each Timepoint Throughout the Study Day 8	38.4 Percentage of participants	33.3 Percentage of participants	38.6 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Days 3, 5, 8, 14 and 21

PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues). PRESORS overall RSV symptoms summary parameter consisted of 12-items, each item score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=47 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=47 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=32 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=33 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=28 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Change From Baseline in Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcomes Rating System (PRESORS) Scores Day 8	-1.25 Units on a scale Standard Deviation 0.537	-1.15 Units on a scale Standard Deviation 0.581	-1.39 Units on a scale Standard Deviation 0.514	-0.85 Units on a scale Standard Deviation 0.526	-0.83 Units on a scale Standard Deviation 0.582	-1.04 Units on a scale Standard Deviation 0.628
Change From Baseline in Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcomes Rating System (PRESORS) Scores Day 14	-1.39 Units on a scale Standard Deviation 0.582	-1.40 Units on a scale Standard Deviation 0.591	-1.59 Units on a scale Standard Deviation 0.458	-1.06 Units on a scale Standard Deviation 0.529	-1.08 Units on a scale Standard Deviation 0.568	-1.24 Units on a scale Standard Deviation 0.681
Change From Baseline in Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcomes Rating System (PRESORS) Scores Day 3	-0.55 Units on a scale Standard Deviation 0.618	-0.51 Units on a scale Standard Deviation 0.571	-0.70 Units on a scale Standard Deviation 0.594	-0.25 Units on a scale Standard Deviation 0.576	-0.15 Units on a scale Standard Deviation 0.427	-0.21 Units on a scale Standard Deviation 0.537
Change From Baseline in Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcomes Rating System (PRESORS) Scores Day 5	-0.88 Units on a scale Standard Deviation 0.542	-0.91 Units on a scale Standard Deviation 0.585	-1.11 Units on a scale Standard Deviation 0.581	-0.48 Units on a scale Standard Deviation 0.572	-0.52 Units on a scale Standard Deviation 0.558	-0.58 Units on a scale Standard Deviation 0.644
Change From Baseline in Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcomes Rating System (PRESORS) Scores Day 21	-1.33 Units on a scale Standard Deviation 0.559	-1.41 Units on a scale Standard Deviation 0.637	-1.56 Units on a scale Standard Deviation 0.468	-1.12 Units on a scale Standard Deviation 0.529	-1.15 Units on a scale Standard Deviation 0.496	-1.29 Units on a scale Standard Deviation 0.596

SECONDARY outcome

Timeframe: Baseline, up to Days 3, 5, 8, 14 and 21

Change from baseline in clinician PRESORS scores (for concepts: activity level, sleep disturbance, breathing problems, retractions, tachypnea, feeding problem, cough, nasal secretions, wheezing, dehydration) was assessed. Clinician PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease and consisted of 10-items, each item score ranges from 0 to 3. Overall RSV symptoms summary parameter was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=47 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=47 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=32 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=33 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=28 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Change From Baseline in Clinician PRESORS Score Day 3	-0.45 Units on a scale Standard Deviation 0.517	-0.45 Units on a scale Standard Deviation 0.441	-0.48 Units on a scale Standard Deviation 0.469	-0.25 Units on a scale Standard Deviation 0.424	-0.21 Units on a scale Standard Deviation 0.378	-0.29 Units on a scale Standard Deviation 0.338
Change From Baseline in Clinician PRESORS Score Day 5	-0.71 Units on a scale Standard Deviation 0.424	-0.73 Units on a scale Standard Deviation 0.582	-0.83 Units on a scale Standard Deviation 0.483	-0.38 Units on a scale Standard Deviation 0.415	-0.37 Units on a scale Standard Deviation 0.462	-0.60 Units on a scale Standard Deviation 0.516
Change From Baseline in Clinician PRESORS Score Day 8	-1.04 Units on a scale Standard Deviation 0.396	-0.92 Units on a scale Standard Deviation 0.461	-1.04 Units on a scale Standard Deviation 0.449	-0.71 Units on a scale Standard Deviation 0.529	-0.63 Units on a scale Standard Deviation 0.423	-0.85 Units on a scale Standard Deviation 0.552
Change From Baseline in Clinician PRESORS Score Day 14	-1.11 Units on a scale Standard Deviation 0.428	-1.10 Units on a scale Standard Deviation 0.466	-1.14 Units on a scale Standard Deviation 0.369	-0.81 Units on a scale Standard Deviation 0.497	-0.77 Units on a scale Standard Deviation 0.436	-0.91 Units on a scale Standard Deviation 0.541
Change From Baseline in Clinician PRESORS Score Day 21	-1.12 Units on a scale Standard Deviation 0.433	-1.13 Units on a scale Standard Deviation 0.424	-1.17 Units on a scale Standard Deviation 0.336	-0.87 Units on a scale Standard Deviation 0.455	-0.81 Units on a scale Standard Deviation 0.411	-0.93 Units on a scale Standard Deviation 0.524

SECONDARY outcome

Timeframe: Up to Day 21

Time to resolution is defined as time from first dose of study drug until the first time of resolution of all RSV symptoms (breathing problems, retractions, tachypnea, breathing sounds, cough, tachycardia, nasal secretions, sleep disturbance, crying, illness behavior, feeding problems, and dehydration). Resolution occurs when all symptoms from the caregiver reported outcomes (ObsRO) are scored as none or mild (score of 0 or 1, respectively) for at least 24 hours.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=47 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=47 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=32 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=33 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=28 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Time to Resolution of RSV Symptoms Based on PRESORS Caregiver (ObsRO)	163.6 Hours Interval 108.7 to 198.7	193.5 Hours Interval 161.8 to 243.8	151.8 Hours Interval 114.7 to 223.7	166.6 Hours Interval 141.5 to 207.2	206.1 Hours Interval 159.2 to 232.8	176.9 Hours Interval 148.3 to 264.2

SECONDARY outcome

Timeframe: Up to Day 21

Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Time to improvement based on general questions on overall health was assessed. Time from first dose of study drug until first time status of improvement of RSV symptoms reported as "very much improved" or "much improved" based on response to question 'Would you say the child's RSV symptoms have improved, are about the same or are worse than when the child entered the study'.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=45 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=43 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=32 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=32 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=28 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Time to Improvement on Overall Health	190.2 Hours Interval 188.7 to 200.0	189.6 Hours Interval 187.8 to 192.5	189.1 Hours Interval 186.9 to 191.9	186.8 Hours Interval 184.3 to 190.4	198.2 Hours Interval 185.3 to 237.3	187.9 Hours Interval 185.9 to 189.8

SECONDARY outcome

Timeframe: Baseline, Days 3, 5, 8, 14, and 21

Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above LLOQ of RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants who were evaluable at specified timepoints.

Percentage of participants by status of RSV symptoms based on PRESORS caregiver (ObsRO) general question over time was assessed. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues). Status of RSV symptoms was assessed by a question (how would you rate the child's RSV symptoms now?) of PRESORS questionnaire and responses were categorized as: 1) none, 2) very mild, 3) mild, 4) moderate, 5) severe, and 6) very severe.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=47 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=47 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=32 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=33 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=28 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Baseline: Mild	7.0 Percentage of participants	6.7 Percentage of participants	4.9 Percentage of participants	32.1 Percentage of participants	22.2 Percentage of participants	19.2 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 3: Moderate	48.8 Percentage of participants	46.8 Percentage of participants	43.2 Percentage of participants	62.1 Percentage of participants	64.5 Percentage of participants	64.3 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 5: Very mild	23.3 Percentage of participants	23.4 Percentage of participants	16.3 Percentage of participants	10.0 Percentage of participants	12.5 Percentage of participants	10.7 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 5: Moderate	39.5 Percentage of participants	21.3 Percentage of participants	41.9 Percentage of participants	46.7 Percentage of participants	43.8 Percentage of participants	46.4 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 8: None	16.3 Percentage of participants	13.0 Percentage of participants	26.2 Percentage of participants	12.9 Percentage of participants	6.1 Percentage of participants	7.4 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 8: Severe	0 Percentage of participants	2.2 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 14: None	55.0 Percentage of participants	48.8 Percentage of participants	58.5 Percentage of participants	70.0 Percentage of participants	63.3 Percentage of participants	67.9 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 14: Very mild	30.0 Percentage of participants	36.6 Percentage of participants	26.8 Percentage of participants	20.0 Percentage of participants	13.3 Percentage of participants	17.9 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 21: None	67.6 Percentage of participants	66.7 Percentage of participants	57.6 Percentage of participants	84.0 Percentage of participants	83.3 Percentage of participants	86.4 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 21: Very mild	18.9 Percentage of participants	18.5 Percentage of participants	24.2 Percentage of participants	8.0 Percentage of participants	12.5 Percentage of participants	4.5 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 21: Severe	2.7 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 21: Very severe	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 8: Very severe	0 Percentage of participants	2.2 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	3.7 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 3: Very severe	2.3 Percentage of participants	6.4 Percentage of participants	4.5 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 5: None	0 Percentage of participants	2.1 Percentage of participants	7.0 Percentage of participants	3.3 Percentage of participants	0 Percentage of participants	3.6 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 3: Severe	18.6 Percentage of participants	17.0 Percentage of participants	9.1 Percentage of participants	6.9 Percentage of participants	12.9 Percentage of participants	10.7 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Baseline: None	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Baseline: Very mild	0 Percentage of participants	0 Percentage of participants	2.4 Percentage of participants	7.1 Percentage of participants	7.4 Percentage of participants	3.8 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 5: Mild	27.9 Percentage of participants	38.3 Percentage of participants	32.6 Percentage of participants	36.7 Percentage of participants	43.8 Percentage of participants	32.1 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 5: Severe	9.3 Percentage of participants	10.6 Percentage of participants	2.3 Percentage of participants	3.3 Percentage of participants	0 Percentage of participants	7.1 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 5: Very severe	0 Percentage of participants	4.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 8: Very mild	37.2 Percentage of participants	30.4 Percentage of participants	28.6 Percentage of participants	35.5 Percentage of participants	45.5 Percentage of participants	25.9 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 8: Mild	23.3 Percentage of participants	34.8 Percentage of participants	28.6 Percentage of participants	38.7 Percentage of participants	27.3 Percentage of participants	48.1 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 8: Moderate	23.3 Percentage of participants	17.4 Percentage of participants	16.7 Percentage of participants	12.9 Percentage of participants	21.2 Percentage of participants	14.8 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 14: Mild	2.5 Percentage of participants	12.2 Percentage of participants	7.3 Percentage of participants	6.7 Percentage of participants	16.7 Percentage of participants	10.7 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 14: Moderate	10.0 Percentage of participants	2.4 Percentage of participants	7.3 Percentage of participants	3.3 Percentage of participants	6.7 Percentage of participants	0 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 14: Severe	2.5 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	3.6 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 14: Very severe	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 21: Mild	2.7 Percentage of participants	11.1 Percentage of participants	12.1 Percentage of participants	0 Percentage of participants	4.2 Percentage of participants	9.1 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 21: Moderate	8.1 Percentage of participants	3.7 Percentage of participants	6.1 Percentage of participants	8.0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Baseline: Moderate	55.8 Percentage of participants	51.1 Percentage of participants	51.2 Percentage of participants	53.6 Percentage of participants	55.6 Percentage of participants	46.2 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Baseline: Severe	27.9 Percentage of participants	37.8 Percentage of participants	41.5 Percentage of participants	7.1 Percentage of participants	14.8 Percentage of participants	30.8 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Baseline: Very severe	9.3 Percentage of participants	4.4 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 3: None	2.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants	3.4 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 3: Very mild	9.3 Percentage of participants	6.4 Percentage of participants	6.8 Percentage of participants	0 Percentage of participants	3.2 Percentage of participants	0 Percentage of participants
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 3: Mild	18.6 Percentage of participants	23.4 Percentage of participants	36.4 Percentage of participants	27.6 Percentage of participants	19.4 Percentage of participants	25.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Days 3, 5, 8, 14, and 21

Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above LLOQ of RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants who were evaluable at specified timepoints.

Percentage of participants by health status assessment based on PRESORS caregiver (ObsRO) general question over time was assessed. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues). Health status was assessed by a question (how is the child's health now) of PRESORS questionnaire and responses were categorized as: 1) excellent, 2) very good, 3) good, 4) fair, 5) poor, and 6) very poor.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=47 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=47 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=32 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=33 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=28 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Baseline: Very good	4.7 Percentage of participants	0 Percentage of participants	0 Percentage of participants	3.6 Percentage of participants	0 Percentage of participants	7.7 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Baseline: Poor	30.2 Percentage of participants	48.9 Percentage of participants	48.8 Percentage of participants	25.0 Percentage of participants	44.4 Percentage of participants	65.4 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Baseline: Very poor	4.7 Percentage of participants	4.4 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 3: Excellent	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	3.4 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 3: Fair	46.5 Percentage of participants	38.3 Percentage of participants	45.5 Percentage of participants	58.6 Percentage of participants	41.9 Percentage of participants	53.6 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 3: Poor	23.3 Percentage of participants	21.3 Percentage of participants	13.6 Percentage of participants	20.7 Percentage of participants	45.2 Percentage of participants	35.7 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 5: Very good	9.3 Percentage of participants	19.1 Percentage of participants	20.9 Percentage of participants	0 Percentage of participants	6.3 Percentage of participants	3.6 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 5: Poor	9.3 Percentage of participants	12.8 Percentage of participants	7.0 Percentage of participants	3.3 Percentage of participants	21.9 Percentage of participants	25.0 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 8: Good	32.6 Percentage of participants	32.6 Percentage of participants	38.1 Percentage of participants	48.4 Percentage of participants	36.4 Percentage of participants	33.3 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 8: Fair	25.6 Percentage of participants	23.9 Percentage of participants	21.4 Percentage of participants	22.6 Percentage of participants	36.4 Percentage of participants	33.3 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 8: Poor	0 Percentage of participants	4.3 Percentage of participants	2.4 Percentage of participants	3.2 Percentage of participants	3.0 Percentage of participants	3.7 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 14: Excellent	42.5 Percentage of participants	24.4 Percentage of participants	43.9 Percentage of participants	50.0 Percentage of participants	56.7 Percentage of participants	53.6 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 21: Good	13.5 Percentage of participants	11.1 Percentage of participants	15.2 Percentage of participants	8.0 Percentage of participants	4.2 Percentage of participants	13.6 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 21: Fair	5.4 Percentage of participants	11.1 Percentage of participants	6.1 Percentage of participants	0 Percentage of participants	4.2 Percentage of participants	9.1 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Baseline: Excellent	2.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	3.7 Percentage of participants	0 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Baseline: Good	7.0 Percentage of participants	4.4 Percentage of participants	7.3 Percentage of participants	14.3 Percentage of participants	11.1 Percentage of participants	3.8 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Baseline: Fair	51.2 Percentage of participants	42.2 Percentage of participants	43.9 Percentage of participants	57.1 Percentage of participants	40.7 Percentage of participants	23.1 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 3: Very good	9.3 Percentage of participants	8.5 Percentage of participants	2.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 3: Good	20.9 Percentage of participants	23.4 Percentage of participants	34.1 Percentage of participants	17.2 Percentage of participants	12.9 Percentage of participants	10.7 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 3: Very poor	0 Percentage of participants	8.5 Percentage of participants	4.5 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 5: Excellent	0 Percentage of participants	2.1 Percentage of participants	0 Percentage of participants	6.7 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 5: Good	41.9 Percentage of participants	23.4 Percentage of participants	37.2 Percentage of participants	26.7 Percentage of participants	31.3 Percentage of participants	28.6 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 5: Fair	39.5 Percentage of participants	36.2 Percentage of participants	34.9 Percentage of participants	63.3 Percentage of participants	40.6 Percentage of participants	42.9 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 5: Very poor	0 Percentage of participants	6.4 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 8: Excellent	9.3 Percentage of participants	13.0 Percentage of participants	16.7 Percentage of participants	6.5 Percentage of participants	3.0 Percentage of participants	3.7 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 8: Very good	32.6 Percentage of participants	23.9 Percentage of participants	21.4 Percentage of participants	19.4 Percentage of participants	21.2 Percentage of participants	22.2 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 8: Very poor	0 Percentage of participants	2.2 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	3.7 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 14: Very good	47.5 Percentage of participants	43.9 Percentage of participants	36.6 Percentage of participants	23.3 Percentage of participants	16.7 Percentage of participants	28.6 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 14: Good	5.0 Percentage of participants	19.5 Percentage of participants	9.8 Percentage of participants	20.0 Percentage of participants	16.7 Percentage of participants	7.1 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 14: Fair	5.0 Percentage of participants	9.8 Percentage of participants	7.3 Percentage of participants	6.7 Percentage of participants	6.7 Percentage of participants	3.6 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 14: Poor	0 Percentage of participants	2.4 Percentage of participants	2.4 Percentage of participants	0 Percentage of participants	3.3 Percentage of participants	3.6 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 14: Very poor	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	3.6 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 21: Excellent	45.9 Percentage of participants	55.6 Percentage of participants	45.5 Percentage of participants	60.0 Percentage of participants	79.2 Percentage of participants	68.2 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 21: Very poor	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 21: Very good	32.4 Percentage of participants	22.2 Percentage of participants	33.3 Percentage of participants	28.0 Percentage of participants	12.5 Percentage of participants	9.1 Percentage of participants
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 21: Poor	2.7 Percentage of participants	0 Percentage of participants	0 Percentage of participants	4.0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Days 14 and 21

Percentage of participants with worsening or improvement of RSV disease based on general questions of overall health was assessed. Improvement or worsening was assessed by a question 'Would you say the child's RSV symptoms have improved, are about the same or are worse than when the child entered the study' and responses were categorized as: 1) very much improved, 2) much improved, 3) a little improved, 4) about the same, 5) a little worse, 6) much worse, and 7) very much worse".

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=47 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=47 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=32 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=33 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=28 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Percentage of Participants With Worsening or Improvement Status of RSV Disease Day 14: Very much improved	57.5 Percentage of participants	58.5 Percentage of participants	67.5 Percentage of participants	76.7 Percentage of participants	51.7 Percentage of participants	64.3 Percentage of participants
Percentage of Participants With Worsening or Improvement Status of RSV Disease Day 21: About the same	2.8 Percentage of participants	3.7 Percentage of participants	3.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Worsening or Improvement Status of RSV Disease Day 14: Much improved	40.0 Percentage of participants	34.1 Percentage of participants	30.0 Percentage of participants	20.0 Percentage of participants	37.9 Percentage of participants	32.1 Percentage of participants
Percentage of Participants With Worsening or Improvement Status of RSV Disease Day 14: A little improved	2.5 Percentage of participants	7.3 Percentage of participants	2.5 Percentage of participants	0 Percentage of participants	3.4 Percentage of participants	0 Percentage of participants
Percentage of Participants With Worsening or Improvement Status of RSV Disease Day 14: About the same	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	3.3 Percentage of participants	3.4 Percentage of participants	3.6 Percentage of participants
Percentage of Participants With Worsening or Improvement Status of RSV Disease Day 14: A little worse	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	3.4 Percentage of participants	0 Percentage of participants
Percentage of Participants With Worsening or Improvement Status of RSV Disease Day 14: Much worse	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Worsening or Improvement Status of RSV Disease Day 14: Very much worse	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Worsening or Improvement Status of RSV Disease Day 21: Very much improved	63.9 Percentage of participants	77.8 Percentage of participants	56.3 Percentage of participants	76.0 Percentage of participants	78.3 Percentage of participants	77.3 Percentage of participants
Percentage of Participants With Worsening or Improvement Status of RSV Disease Day 21: Much improved	30.6 Percentage of participants	14.8 Percentage of participants	37.5 Percentage of participants	24.0 Percentage of participants	21.7 Percentage of participants	13.6 Percentage of participants
Percentage of Participants With Worsening or Improvement Status of RSV Disease Day 21: A little improved	2.8 Percentage of participants	3.7 Percentage of participants	3.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Worsening or Improvement Status of RSV Disease Day 21: A little worse	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	9.1 Percentage of participants
Percentage of Participants With Worsening or Improvement Status of RSV Disease Day 21: Much worse	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Worsening or Improvement Status of RSV Disease Day 21: Very much worse	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Days 3, 5, 8, 14, and 21

Percentage of participants by return to pre-RSV disease health status assessment based on PRESORS caregiver (ObsRO) general question over time was assessed by a question (Has the child's health returned to normal \[how it was before RSV?\]) of PRESORS questionnaire and responses were categorized as: 1) No, and 2) Yes. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues). Below results are reported for category 'Yes'.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=47 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=47 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=32 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=33 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=28 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Percentage of Participants by Return to Pre-RSV Disease Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 21	86.1 Percentage of participants	81.5 Percentage of participants	84.4 Percentage of participants	92.0 Percentage of participants	95.7 Percentage of participants	95.5 Percentage of participants
Percentage of Participants by Return to Pre-RSV Disease Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 8	44.7 Percentage of participants	37.5 Percentage of participants	58.8 Percentage of participants	51.9 Percentage of participants	36.0 Percentage of participants	10.0 Percentage of participants
Percentage of Participants by Return to Pre-RSV Disease Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 14	77.8 Percentage of participants	72.4 Percentage of participants	84.4 Percentage of participants	81.5 Percentage of participants	85.7 Percentage of participants	73.1 Percentage of participants
Percentage of Participants by Return to Pre-RSV Disease Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Baseline	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	22.2 Percentage of participants	0 Percentage of participants	12.5 Percentage of participants
Percentage of Participants by Return to Pre-RSV Disease Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 3	8.6 Percentage of participants	15.4 Percentage of participants	28.1 Percentage of participants	12.0 Percentage of participants	12.0 Percentage of participants	4.3 Percentage of participants
Percentage of Participants by Return to Pre-RSV Disease Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time Day 5	16.2 Percentage of participants	23.8 Percentage of participants	25.6 Percentage of participants	16.0 Percentage of participants	4.3 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Days 3, 5, 8, 14 and 21

Population: The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned. Here, 'n' (number analyzed) represents number of participants who were evaluable at specified timepoints.

Respiratory rate (RR) was measured by the investigator over time.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=49 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=50 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Respiratory Rate (RR) Over Time Day 8	34.4 Breaths/minute Standard Deviation 7.87	35.5 Breaths/minute Standard Deviation 7.90	39.2 Breaths/minute Standard Deviation 9.45	37.4 Breaths/minute Standard Deviation 11.70	36.9 Breaths/minute Standard Deviation 9.75	34.0 Breaths/minute Standard Deviation 10.54
Respiratory Rate (RR) Over Time Baseline	45.6 Breaths/minute Standard Deviation 11.82	45.0 Breaths/minute Standard Deviation 10.60	45.7 Breaths/minute Standard Deviation 10.85	41.3 Breaths/minute Standard Deviation 13.66	41.3 Breaths/minute Standard Deviation 11.76	37.0 Breaths/minute Standard Deviation 8.77
Respiratory Rate (RR) Over Time Day 3	41.8 Breaths/minute Standard Deviation 10.13	44.1 Breaths/minute Standard Deviation 11.44	42.7 Breaths/minute Standard Deviation 10.04	37.9 Breaths/minute Standard Deviation 10.16	37.3 Breaths/minute Standard Deviation 9.54	34.4 Breaths/minute Standard Deviation 9.19
Respiratory Rate (RR) Over Time Day 5	38.1 Breaths/minute Standard Deviation 9.57	38.3 Breaths/minute Standard Deviation 9.36	39.1 Breaths/minute Standard Deviation 8.81	38.2 Breaths/minute Standard Deviation 13.37	38.1 Breaths/minute Standard Deviation 8.89	35.4 Breaths/minute Standard Deviation 9.53
Respiratory Rate (RR) Over Time Day 14	34.9 Breaths/minute Standard Deviation 8.89	35.6 Breaths/minute Standard Deviation 7.13	35.2 Breaths/minute Standard Deviation 7.45	35.7 Breaths/minute Standard Deviation 9.27	35.6 Breaths/minute Standard Deviation 10.53	32.6 Breaths/minute Standard Deviation 8.38
Respiratory Rate (RR) Over Time Day 21	34.9 Breaths/minute Standard Deviation 8.96	36.07 Breaths/minute Standard Deviation 10.21	36.6 Breaths/minute Standard Deviation 7.43	36.4 Breaths/minute Standard Deviation 9.61	35.5 Breaths/minute Standard Deviation 9.65	34.7 Breaths/minute Standard Deviation 11.09

SECONDARY outcome

Timeframe: Baseline to Days 3, 5, 8, 14 and 21

Change from baseline in respiratory rate was derived based on the reported measurements of respiratory rate over time. The respiratory rate over time was reported by the investigator.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=49 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=50 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Change From Baseline in Respiratory Rate Day 3	-3.5 Breaths/minute Standard Deviation 11.99	-0.8 Breaths/minute Standard Deviation 10.88	-3.0 Breaths/minute Standard Deviation 12.43	-3.7 Breaths/minute Standard Deviation 12.47	-4.0 Breaths/minute Standard Deviation 9.54	-2.6 Breaths/minute Standard Deviation 9.20
Change From Baseline in Respiratory Rate Day 5	-7.1 Breaths/minute Standard Deviation 11.13	-6.5 Breaths/minute Standard Deviation 9.41	-7.0 Breaths/minute Standard Deviation 11.94	-3.4 Breaths/minute Standard Deviation 8.59	-3.3 Breaths/minute Standard Deviation 8.40	-1.5 Breaths/minute Standard Deviation 9.62
Change From Baseline in Respiratory Rate Day 8	-11.4 Breaths/minute Standard Deviation 12.96	-9.4 Breaths/minute Standard Deviation 9.19	-6.3 Breaths/minute Standard Deviation 12.69	-4.4 Breaths/minute Standard Deviation 11.56	-4.4 Breaths/minute Standard Deviation 10.39	-2.9 Breaths/minute Standard Deviation 10.54
Change From Baseline in Respiratory Rate Day 14	-10.3 Breaths/minute Standard Deviation 12.59	-9.3 Breaths/minute Standard Deviation 9.96	-10.2 Breaths/minute Standard Deviation 10.92	-6.4 Breaths/minute Standard Deviation 3.13	-5.8 Breaths/minute Standard Deviation 12.82	-4.0 Breaths/minute Standard Deviation 9.92
Change From Baseline in Respiratory Rate Day 21	-10.4 Breaths/minute Standard Deviation 13.01	-8.4 Breaths/minute Standard Deviation 10.84	-9.8 Breaths/minute Standard Deviation 12.36	-5.5 Breaths/minute Standard Deviation 14.15	-5.8 Breaths/minute Standard Deviation 11.95	-2.3 Breaths/minute Standard Deviation 13.25

SECONDARY outcome

Timeframe: Baseline, Days 3, 5, 8, 14 and 21

Heart rate was measured by the investigator over time.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=49 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=50 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Heart Rate Over Time Baseline	138.9 Beats/minute Standard Deviation 17.57	143.2 Beats/minute Standard Deviation 17.40	139.0 Beats/minute Standard Deviation 18.57	131.2 Beats/minute Standard Deviation 24.28	135.6 Beats/minute Standard Deviation 19.35	126.1 Beats/minute Standard Deviation 22.55
Heart Rate Over Time Day 3	137.5 Beats/minute Standard Deviation 18.25	138.8 Beats/minute Standard Deviation 16.82	138.5 Beats/minute Standard Deviation 17.06	127.8 Beats/minute Standard Deviation 20.99	128.3 Beats/minute Standard Deviation 17.97	118.8 Beats/minute Standard Deviation 28.10
Heart Rate Over Time Day 5	132.7 Beats/minute Standard Deviation 18.28	136.0 Beats/minute Standard Deviation 15.81	16.1 Beats/minute Standard Deviation 19.68	119.2 Beats/minute Standard Deviation 14.75	122.6 Beats/minute Standard Deviation 19.85	120.4 Beats/minute Standard Deviation 23.31
Heart Rate Over Time Day 8	127.9 Beats/minute Standard Deviation 18.13	133.3 Beats/minute Standard Deviation 17.59	134.0 Beats/minute Standard Deviation 19.14	118.7 Beats/minute Standard Deviation 20.25	120.0 Beats/minute Standard Deviation 19.61	118.9 Beats/minute Standard Deviation 27.04
Heart Rate Over Time Day 14	132.4 Beats/minute Standard Deviation 19.33	131.7 Beats/minute Standard Deviation 19.81	134.4 Beats/minute Standard Deviation 20.70	117.4 Beats/minute Standard Deviation 18.17	118.0 Beats/minute Standard Deviation 19.17	115.2 Beats/minute Standard Deviation 18.82
Heart Rate Over Time Day 21	131.5 Beats/minute Standard Deviation 15.74	128.2 Beats/minute Standard Deviation 20.27	132.5 Beats/minute Standard Deviation 19.14	117.2 Beats/minute Standard Deviation 22.56	125.3 Beats/minute Standard Deviation 20.95	115.2 Beats/minute Standard Deviation 19.78

SECONDARY outcome

Timeframe: Baseline to Days 3, 5, 8, 14 and 21

Change from baseline in heart rate was assessed.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=49 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=50 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Change From Baseline in Heart Rate Day 3	-1.6 Beats/minute Standard Deviation 19.82	-4.9 Beats/minute Standard Deviation 19.36	-0.6 Beats/minute Standard Deviation 18.84	-3.0 Beats/minute Standard Deviation 24.71	-7.4 Beats/minute Standard Deviation 16.83	-7.3 Beats/minute Standard Deviation 28.39
Change From Baseline in Heart Rate Day 5	-5.8 Beats/minute Standard Deviation 22.94	-7.9 Beats/minute Standard Deviation 20.31	-2.9 Beats/minute Standard Deviation 20.56	-11.6 Beats/minute Standard Deviation 18.55	-13.0 Beats/minute Standard Deviation 17.11	-5.6 Beats/minute Standard Deviation 28.53
Change From Baseline in Heart Rate Day 8	-12.2 Beats/minute Standard Deviation 23.20	-10.4 Beats/minute Standard Deviation 18.45	-5.2 Beats/minute Standard Deviation 22.02	-12.7 Beats/minute Standard Deviation 26.09	-15.6 Beats/minute Standard Deviation 20.67	-7.2 Beats/minute Standard Deviation 35.90
Change From Baseline in Heart Rate Day 14	-6.5 Beats/minute Standard Deviation 23.99	-12.0 Beats/minute Standard Deviation 21.79	-5.1 Beats/minute Standard Deviation 22.44	-14.4 Beats/minute Standard Deviation 24.62	-17.7 Beats/minute Standard Deviation 17.69	-10.1 Beats/minute Standard Deviation 28.02
Change From Baseline in Heart Rate Day 21	-7.7 Beats/minute Standard Deviation 25.88	-15.0 Beats/minute Standard Deviation 23.80	-6.5 Beats/minute Standard Deviation 19.52	-14.0 Beats/minute Standard Deviation 25.38	-10.4 Beats/minute Standard Deviation 21.02	-10.9 Beats/minute Standard Deviation 28.63

SECONDARY outcome

Timeframe: Baseline, Days 3, 5, 8, 14 and 21

Body temperature was reported over time (either investigator or caregiver measured).

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=49 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=50 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Body Temperature Over Time Baseline	36.64 Degrees celsius Standard Deviation 0.468	36.84 Degrees celsius Standard Deviation 0.635	36.82 Degrees celsius Standard Deviation 0.623	36.84 Degrees celsius Standard Deviation 0.613	36.94 Degrees celsius Standard Deviation 0.845	36.79 Degrees celsius Standard Deviation 0.785
Body Temperature Over Time Day 3	36.87 Degrees celsius Standard Deviation 0.524	36.77 Degrees celsius Standard Deviation 0.464	36.80 Degrees celsius Standard Deviation 0.601	37.14 Degrees celsius Standard Deviation 0.725	37.20 Degrees celsius Standard Deviation 0.694	36.98 Degrees celsius Standard Deviation 0.817
Body Temperature Over Time Day 5	36.54 Degrees celsius Standard Deviation 0.557	36.75 Degrees celsius Standard Deviation 0.407	36.70 Degrees celsius Standard Deviation 0.408	36.87 Degrees celsius Standard Deviation 0.567	36.71 Degrees celsius Standard Deviation 0.348	36.84 Degrees celsius Standard Deviation 0.718
Body Temperature Over Time Day 8	36.73 Degrees celsius Standard Deviation 0.513	36.70 Degrees celsius Standard Deviation 0.416	36.65 Degrees celsius Standard Deviation 0.441	36.67 Degrees celsius Standard Deviation 0.369	36.76 Degrees celsius Standard Deviation 0.536	36.74 Degrees celsius Standard Deviation 0.559
Body Temperature Over Time Day 14	36.68 Degrees celsius Standard Deviation 0.440	36.86 Degrees celsius Standard Deviation 0.315	36.60 Degrees celsius Standard Deviation 0.396	36.63 Degrees celsius Standard Deviation 0.357	36.72 Degrees celsius Standard Deviation 0.364	36.59 Degrees celsius Standard Deviation 0.377
Body Temperature Over Time Day 21	36.67 Degrees celsius Standard Deviation 0.407	36.76 Degrees celsius Standard Deviation 0.577	36.66 Degrees celsius Standard Deviation 0.573	36.74 Degrees celsius Standard Deviation 0.615	36.64 Degrees celsius Standard Deviation 0.292	36.62 Degrees celsius Standard Deviation 0.418

SECONDARY outcome

Timeframe: Baseline to Days 3, 5, 8, 14 and 21

Change from baseline in body temperature (either investigator or caregiver measured) was assessed.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=49 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=50 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Change From Baseline in Body Temperature Day 3	0.23 Degrees celsius Standard Deviation 0.541	-0.08 Degrees celsius Standard Deviation 0.697	-0.02 Degrees celsius Standard Deviation 0.629	0.33 Degrees celsius Standard Deviation 0.768	0.26 Degrees celsius Standard Deviation 0.835	0.21 Degrees celsius Standard Deviation 0.724
Change From Baseline in Body Temperature Day 5	-0.09 Degrees celsius Standard Deviation 0.532	-0.10 Degrees celsius Standard Deviation 0.713	-0.12 Degrees celsius Standard Deviation 0.627	0.07 Degrees celsius Standard Deviation 0.700	-0.22 Degrees celsius Standard Deviation 0.767	-0.04 Degrees celsius Standard Deviation 0.627
Change From Baseline in Body Temperature Day 8	0.10 Degrees celsius Standard Deviation 0.600	-0.13 Degrees celsius Standard Deviation 0.659	-0.17 Degrees celsius Standard Deviation 0.596	-0.13 Degrees celsius Standard Deviation 0.588	-0.17 Degrees celsius Standard Deviation 1.016	-0.11 Degrees celsius Standard Deviation 0.772
Change From Baseline in Body Temperature Day 14	0.04 Degrees celsius Standard Deviation 0.528	0.01 Degrees celsius Standard Deviation 0.594	-0.21 Degrees celsius Standard Deviation 0.609	-0.17 Degrees celsius Standard Deviation 0.687	-0.21 Degrees celsius Standard Deviation 0.866	-0.19 Degrees celsius Standard Deviation 0.843
Change From Baseline in Body Temperature Day 21	0.03 Degrees celsius Standard Deviation 0.519	-0.09 Degrees celsius Standard Deviation 0.758	-0.17 Degrees celsius Standard Deviation 0.724	-0.06 Degrees celsius Standard Deviation 0.704	-0.30 Degrees celsius Standard Deviation 0.826	-0.18 Degrees celsius Standard Deviation 0.913

SECONDARY outcome

Timeframe: Baseline, Days 3, 5, 8, 14 and 21

Peripheral capillary oxygen saturation was measured by the investigator over time.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=49 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=50 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Day 21	98.2 Percentage of SpO2 Standard Deviation 1.80	98.4 Percentage of SpO2 Standard Deviation 1.47	98.0 Percentage of SpO2 Standard Deviation 2.12	98.5 Percentage of SpO2 Standard Deviation 1.74	98.7 Percentage of SpO2 Standard Deviation 1.36	98.9 Percentage of SpO2 Standard Deviation 1.25
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Baseline	96.5 Percentage of SpO2 Standard Deviation 3.44	97.3 Percentage of SpO2 Standard Deviation 2.47	96.6 Percentage of SpO2 Standard Deviation 2.10	96.8 Percentage of SpO2 Standard Deviation 2.07	96.7 Percentage of SpO2 Standard Deviation 1.91	95.9 Percentage of SpO2 Standard Deviation 2.92
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Day 3	96.3 Percentage of SpO2 Standard Deviation 2.72	96.8 Percentage of SpO2 Standard Deviation 2.46	96.0 Percentage of SpO2 Standard Deviation 2.43	96.9 Percentage of SpO2 Standard Deviation 1.77	96.3 Percentage of SpO2 Standard Deviation 3.12	96.5 Percentage of SpO2 Standard Deviation 2.96
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Day 5	96.8 Percentage of SpO2 Standard Deviation 3.74	97.3 Percentage of SpO2 Standard Deviation 1.67	96.7 Percentage of SpO2 Standard Deviation 2.25	96.9 Percentage of SpO2 Standard Deviation 1.68	97.1 Percentage of SpO2 Standard Deviation 2.12	97.1 Percentage of SpO2 Standard Deviation 2.43
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Day 8	97.3 Percentage of SpO2 Standard Deviation 2.47	97.3 Percentage of SpO2 Standard Deviation 1.99	97.5 Percentage of SpO2 Standard Deviation 1.74	97.8 Percentage of SpO2 Standard Deviation 1.48	97.4 Percentage of SpO2 Standard Deviation 2.69	97.9 Percentage of SpO2 Standard Deviation 1.83
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Day 14	98.3 Percentage of SpO2 Standard Deviation 1.84	98.1 Percentage of SpO2 Standard Deviation 1.42	98.1 Percentage of SpO2 Standard Deviation 1.64	98.6 Percentage of SpO2 Standard Deviation 2.03	98.6 Percentage of SpO2 Standard Deviation 1.53	98.4 Percentage of SpO2 Standard Deviation 1.73

SECONDARY outcome

Timeframe: Baseline to Days 3, 5, 8, 14, and 21

Change from baseline in peripheral capillary oxygen saturation levels was derived based on reported values over time.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=49 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=50 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Change From Baseline in Peripheral Capillary Oxygen Saturation (SpO2) Day 3	-0.2 Percentage of SpO2 Standard Deviation 3.09	-0.5 Percentage of SpO2 Standard Deviation 2.93	-0.6 Percentage of SpO2 Standard Deviation 2.72	0.2 Percentage of SpO2 Standard Deviation 2.31	-0.4 Percentage of SpO2 Standard Deviation 2.45	0.7 Percentage of SpO2 Standard Deviation 1.63
Change From Baseline in Peripheral Capillary Oxygen Saturation (SpO2) Day 5	0.4 Percentage of SpO2 Standard Deviation 2.93	0.0 Percentage of SpO2 Standard Deviation 2.92	0.1 Percentage of SpO2 Standard Deviation 2.38	0.1 Percentage of SpO2 Standard Deviation 2.49	0.4 Percentage of SpO2 Standard Deviation 2.41	1.2 Percentage of SpO2 Standard Deviation 2.54
Change From Baseline in Peripheral Capillary Oxygen Saturation (SpO2) Day 8	0.9 Percentage of SpO2 Standard Deviation 3.53	0.1 Percentage of SpO2 Standard Deviation 3.02	0.8 Percentage of SpO2 Standard Deviation 2.47	0.9 Percentage of SpO2 Standard Deviation 2.59	0.8 Percentage of SpO2 Standard Deviation 2.86	2.0 Percentage of SpO2 Standard Deviation 3.36
Change From Baseline in Peripheral Capillary Oxygen Saturation (SpO2) Day 14	1.7 Percentage of SpO2 Standard Deviation 3.08	1.0 Percentage of SpO2 Standard Deviation 2.28	1.4 Percentage of SpO2 Standard Deviation 2.32	2.0 Percentage of SpO2 Standard Deviation 2.72	1.8 Percentage of SpO2 Standard Deviation 2.05	2.6 Percentage of SpO2 Standard Deviation 3.06
Change From Baseline in Peripheral Capillary Oxygen Saturation (SpO2) Day 21	1.7 Percentage of SpO2 Standard Deviation 3.38	1.1 Percentage of SpO2 Standard Deviation 2.45	1.3 Percentage of SpO2 Standard Deviation 2.40	1.8 Percentage of SpO2 Standard Deviation 2.57	2.0 Percentage of SpO2 Standard Deviation 2.12	3.0 Percentage of SpO2 Standard Deviation 2.80

SECONDARY outcome

Timeframe: Up to Day 28

Percentage of participants who required (re)hospitalization during treatment and follow-up was assessed. Percentage of participants requiring re-hospitalization following the initial hospital discharge was assessed in Cohort 1 participants (hospitalized cohort) whilst percentage of participants requiring hospitalization after first dose of study drug was assessed in Cohort 2 participants (outpatient cohort).

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=47 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=47 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=32 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=33 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=28 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Percentage of Participants Who Required (re)Hospitalization During Treatment and Follow-up	4.3 Percentage of participants	6.4 Percentage of participants	2.3 Percentage of participants	6.3 Percentage of participants	6.1 Percentage of participants	14.3 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 28

Time to return to age-adjusted normal values from first dose of study drug based on the reported vital signs (respiratory rate, heart rate, SpO2 \>=92%, and SpO2 \>=95%) values was assessed. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=47 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=47 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Time to Return to Age-adjusted Normal Values for Vital Signs Heart Rate	17.0 Hours Interval 0.001 to 67.5	37.3 Hours Interval 0.001 to 51.5	10.2 Hours Interval 0.001 to 160.5	—	—	—
Cohort 1: Time to Return to Age-adjusted Normal Values for Vital Signs SpO2 >=92% on Room Air	86.6 Hours Interval 45.3 to 119.2	65.4 Hours Interval 30.3 to 95.1	68.9 Hours Interval 42.4 to 105.5	—	—	—
Cohort 1: Time to Return to Age-adjusted Normal Values for Vital Signs Respiratory Rate	20.0 Hours Interval 0.001 to 43.5	13.6 Hours Interval 0.001 to 70.1	30.2 Hours Interval 0.001 to 84.5	—	—	—
Cohort 1: Time to Return to Age-adjusted Normal Values for Vital Signs SpO2 >=95% on Room Air	87.0 Hours Interval 47.8 to 120.0	71.3 Hours Interval 47.7 to 99.3	92.5 Hours Interval 48.5 to 141.1	—	—	—

SECONDARY outcome

Timeframe: Up to Day 28

Time to discharge from hospital was derived from the reported discharge date/time and from first dose date/time. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=47 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=47 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Time to Discharge From Hospital	95.3 Hours Interval 67.2 to 140.3	96.2 Hours Interval 88.8 to 118.0	96.2 Hours Interval 72.1 to 144.9	—	—	—

SECONDARY outcome

Timeframe: Up to Day 21

Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Percentage of participants who required admission to the ICU was assessed. This outcome measure was applicable for those participants that were not in ICU before first dose of study drug. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=42 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=39 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Percentage of Participants Who Required Admission to the Intensive Care Unit (ICU)	4.5 Percentage of participants	2.4 Percentage of participants	2.6 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to Day 21

Population: ITT-i analysis set included all randomized participants who were admitted to ICU and received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Duration of ICU stay was derived based on the reported admission/discharge date/time for ICU. Duration defined as total number of hours a participant was in ICU from first dose of study drug until study termination. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=5 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=6 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=6 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Duration of ICU Stay	206.94 Hours Standard Deviation 204.940	238.22 Hours Standard Deviation 70.570	127.72 Hours Standard Deviation 89.389	—	—	—

SECONDARY outcome

Timeframe: Up to Day 21

Time to clinical stability was derived based on vital signs(SpO2 \>= 92%, SpO2 \>=95% on room air) assessments and supplementation end dates as collected. Time to clinical stability=time from initiation of study treatment until time at which following criteria were met: Time to return to age-adjusted normal value for otherwise healthy, pre-RSV infection status for participant with risk factor for severe RSV disease,no more oxygen supplementation in otherwise healthy participant, participant with risk factor for severe RSV disease and no more IV administered/nasogastric tube feeding/hydration supplementation in otherwise healthy participant or pre-RSV status of IV/nasogastric tube feeding/hydration in participant with risk factor for severe RSV disease. As per protocol and study design,this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=47 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=47 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Time to Clinical Stability Evaluated by the Investigator SpO2 >=92% on Room Air	123.3 Hours Interval 82.0 to 169.1	95.8 Hours Interval 63.5 to 165.8	176.5 Hours Interval 77.8 to 309.5	—	—	—
Cohort 1: Time to Clinical Stability Evaluated by the Investigator SpO2 >=95% on Room Air	134.8 Hours Interval 82.0 to 311.5	95.8 Hours Interval 71.2 to 165.9	180.5 Hours Interval 85.7 to 315.4	—	—	—

SECONDARY outcome

Timeframe: Up to Day 21

Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Percentage of participants who required supplemental oxygen after first dose of study drug was reported. This parameter was only for participants that did not require oxygen supplementation before first dose of study drug. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=12 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=14 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=7 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Percentage of Participants Who Required Supplemental Oxygen	25.0 Percentage of participants	21.4 Percentage of participants	28.6 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to Day 28

Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Duration of supplemental oxygen was assessed. Duration was defined as total number of hours a participant used supplemental oxygen from first dose of study drug until study termination. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=38 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=34 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=38 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Duration of Supplemental Oxygen	74.60 Hours Interval 0.2 to 573.5	74.25 Hours Interval 1.0 to 337.3	68.05 Hours Interval 1.2 to 348.5	—	—	—

SECONDARY outcome

Timeframe: Up to Day 21

Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Percentage of participants who required non-invasive mechanical ventilation support (example: continuous positive airway pressure) after first dose of study drug was assessed. This parameter was only for participants who did not require non-invasive mechanical ventilation support before first dose of study drug. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=45 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=38 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Percentage of Participants Who Required Non-invasive Mechanical Ventilation Support	6.8 Percentage of participants	2.2 Percentage of participants	2.6 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to Day 21

Percentage of participants who required invasive mechanical ventilation support (example: endotracheal-mechanical ventilation) after first dose of study drug was assessed. This parameter was only for participants who did not require invasive mechanical ventilation support before first dose of study drug. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=47 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=47 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Percentage of Participants Who Required Invasive Mechanical Ventilation Support	2.1 Percentage of participants	4.3 Percentage of participants	2.3 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to Day 21

Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Percentage of participants who required non-invasive non-mechanical ventilation support (example: nasal cannula) after first dose of study drug was assessed. This parameter was only for participants who did not require non-invasive non-mechanical ventilation support before first dose of study drug. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=14 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=16 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=11 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Percentage of Participants Who Required Non-invasive Non-mechanical Ventilation Support	35.7 Percentage of participants	31.3 Percentage of participants	45.5 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to Day 21

Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above LLOQ of RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants who were evaluable at specified categories.

For the subset of participants who received non-invasive ventilation post dose, duration for non-invasive ventilation could not be derived by individual type as start/end dates and times were not collected in full to allow breakdown of duration derivation by ventilation type and only overall duration of oxygen supplementation (overall ventilation support) could be derived which is reported in the outcome measure "Duration of Supplemental Oxygen". As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure could only have been reported for Cohort 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 21

For the subset of participants who received invasive ventilation post dose, duration for invasive ventilation could not be derived by individual type as start/end dates and times were not collected in full to allow breakdown of duration derivation by ventilation type and only overall duration of oxygen supplementation (overall ventilation support) could be derived which is reported in the outcome measure "Duration of Supplemental Oxygen". As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure could only have been reported for Cohort 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to end of supplemental oxygen including supplemental oxygen within 72 hours after first hospital discharge (up to Day 28)

Time to end of supplemental oxygen up to 72 hours from first hospital discharge was assessed. Time to end of supplemental oxygen was defined as time (hours) from first dose of study drug to last end date/time of any oxygen supplementation received, but within 72 hours following first hospital discharge. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=47 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=47 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Time to End of Supplemental Oxygen up to 72 Hours From First Hospital Discharge	57.9 Hours Interval 35.3 to 85.5	58.1 Hours Interval 22.9 to 75.9	63.0 Hours Interval 31.8 to 92.0	—	—	—

SECONDARY outcome

Timeframe: Up to Day 28

Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Percentage of participants who needed hydration and/or feeding by IV Administration or nasogastric tube after the first dose of study drug was assessed. This parameter was only for participants who didn't require supplemental feeding/hydration before first dose of study drug. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=32 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=32 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=26 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Percentage of Participants Who Needed Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube	15.6 Percentage of participants	6.3 Percentage of participants	19.2 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to Day 28

Population: The safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.

Percentage of participants with adverse events was assessed. An AE is any untoward medical occurrence in clinical study participants administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=49 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=50 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Percentage of Participants With Adverse Events	59.2 Percentage of Participants	58.0 Percentage of Participants	64.6 Percentage of Participants	47.1 Percentage of Participants	58.8 Percentage of Participants	41.9 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 28

Percentage of participants with abnormal laboratory findings (chemistry and hematology) worst toxicity grade was assessed based on Division of Microbiology and Infectious Diseases (DMID) toxicity grading scale. DMID toxicity grades range from 1 to 4. Grade 1 = mild: transient or mild discomfort (\<48 hours); no medical intervention/therapy required. Grade 2 = moderate: mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Grade 3 = severe: marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. Grade 4 = life-threatening or death: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=49 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=50 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Hyperbilirubinemia: Grade 2	0 Percentage of Participants	2.7 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Hypomagnesemia: Grade 3	0 Percentage of Participants	0 Percentage of Participants	4.3 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Hematology: Hemoglobin: Grade 1	5.6 Percentage of Participants	7.9 Percentage of Participants	2.9 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Hematology: Hemoglobin: Grade 2	2.8 Percentage of Participants	2.6 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Hematology: Prothrombin Time: Grade 1	10.0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Hematology: Prothrombin Time: Grade 3	0 Percentage of Participants	11.1 Percentage of Participants	6.7 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: AST: Grade 3	0 Percentage of Participants	4.5 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Hyperglycemia: Grade 1	0 Percentage of Participants	13.6 Percentage of Participants	4.3 Percentage of Participants	6.3 Percentage of Participants	3.4 Percentage of Participants	10.0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Hyperkalemia: Grade 1	22.2 Percentage of Participants	59.1 Percentage of Participants	39.1 Percentage of Participants	21.9 Percentage of Participants	55.2 Percentage of Participants	36.7 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Hyperkalemia: Grade 2	0 Percentage of Participants	0 Percentage of Participants	4.3 Percentage of Participants	3.1 Percentage of Participants	3.4 Percentage of Participants	3.3 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Hyperkalemia: Grade 4	0 Percentage of Participants	0 Percentage of Participants	8.7 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Hypernatremia: Grade 2	3.7 Percentage of Participants	4.5 Percentage of Participants	0 Percentage of Participants	3.1 Percentage of Participants	3.4 Percentage of Participants	3.3 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Hypernatremia: Grade 3	0 Percentage of Participants	4.5 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Hyperuricemia: Grade 1	0 Percentage of Participants	0 Percentage of Participants	4.3 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Hypoglycemia: Grade 1	0 Percentage of Participants	4.5 Percentage of Participants	4.3 Percentage of Participants	6.3 Percentage of Participants	3.4 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Hypomagnesemia: Grade 1	3.7 Percentage of Participants	0 Percentage of Participants	4.3 Percentage of Participants	3.1 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Hypomagnesemia: Grade 2	0 Percentage of Participants	0 Percentage of Participants	4.3 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Hyponatremia: Grade 2	3.7 Percentage of Participants	4.5 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	10.0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Hematology: Absolute Neutrophil Count: Grade 1	11.4 Percentage of Participants	13.5 Percentage of Participants	2.8 Percentage of Participants	3.0 Percentage of Participants	9.1 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Hematology: Absolute Neutrophil Count: Grade 3	2.9 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Hematology: Activated Partial Thromboplastin Time: Grade 1	0 Percentage of Participants	11.1 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	33.3 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Alanine Transaminase (ALT): Grade 1	0 Percentage of Participants	13.6 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	3.6 Percentage of Participants	3.4 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: ALT: Grade 2	0 Percentage of Participants	0 Percentage of Participants	4.5 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: ALT: Grade 3	0 Percentage of Participants	4.5 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Aspartate Aminotransferase (AST): Grade 1	0 Percentage of Participants	0 Percentage of Participants	4.5 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	3.3 Percentage of Participants
Percentage of Participants With Abnormal Laboratory Findings Chemistry: Hyperglycemia: Grade 2	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	3.3 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 28

Percentage of participants with abnormal ECG (PR interval \[for age 0 to 2 years: \>150 msec is abnormally high, for age group 2 to \<3.5 years: \<100 msec is abnormally low and \>150 msec is abnormally high\]; QRS interval \[for 0 to 2 years: \>79 msec is abnormally high, for age group 2 to \<3.5 years: \<40 msec is abnormally low and \>79 msec is abnormally high\]; QT interval \[for age 0 to 2 years: \>500 msec is abnormally high, for age group 2 to \<18 years: \<320 msec is abnormally low and \>450 msec is abnormally high\]; RR interval \[for age 0 to 3 months: \<333 msec is abnormally low and \>750 msec is abnormally high; for age group 3 to 12 months: \<400 msec is abnormally low and \>860 msec is abnormally high; for age 1 to 2 years: \<430 msec is abnormally low and \>1000 msec is abnormally high; for age group 2 to \<18 years: \<600 msec is abnormally low and \>1200 msec is abnormally high\]) findings were assessed.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=49 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=50 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings QRS Duration: Abnormally High	4.2 Percentage of Participants	4.1 Percentage of Participants	4.2 Percentage of Participants	6.1 Percentage of Participants	6.1 Percentage of Participants	9.7 Percentage of Participants
Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings RR Interval: Abnormally Low	8.3 Percentage of Participants	12.2 Percentage of Participants	12.5 Percentage of Participants	21.2 Percentage of Participants	15.2 Percentage of Participants	9.7 Percentage of Participants
Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings PR Interval: Abnormally Low	2.1 Percentage of Participants	0 Percentage of Participants	2.1 Percentage of Participants	0 Percentage of Participants	3.0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings QT Interval: Abnormally Low	4.2 Percentage of Participants	2.0 Percentage of Participants	2.1 Percentage of Participants	3.0 Percentage of Participants	9.1 Percentage of Participants	3.2 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to Day 28

Percentage of participants with categorized change from Baseline in ECG parameters (QT/ QTcB/ QTcF interval) was assessed. Abnormal ECG change from baseline in QTc and QTcB Interval is categorized as borderline QTc change: 30 ms (milliseconds) to \<60 ms, and abnormally high QTc change: greater than \[\>\] 60 ms), and QTcF Interval is categorized as borderline QTc change: 30 ms to \<60 ms, and abnormally high QTc change: \>60 ms.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=49 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=50 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Percentage of Participants With Categorized Change From Baseline in ECG Parameters (QT, QTcB, QTcF) QTcB Interval: Normal QTc change	87.5 Percentage of participants	83.8 Percentage of participants	93.8 Percentage of participants	90.9 Percentage of participants	90.9 Percentage of participants	93.1 Percentage of participants
Percentage of Participants With Categorized Change From Baseline in ECG Parameters (QT, QTcB, QTcF) QTcB Interval: Abnormally high QTc change	0 Percentage of participants	2.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Categorized Change From Baseline in ECG Parameters (QT, QTcB, QTcF) QTcF Interval: Normal QTc change	83.3 Percentage of participants	81.3 Percentage of participants	83.3 Percentage of participants	90.9 Percentage of participants	78.8 Percentage of participants	86.3 Percentage of participants
Percentage of Participants With Categorized Change From Baseline in ECG Parameters (QT, QTcB, QTcF) QTcF Interval: Borderline QTc change	16.7 Percentage of participants	16.7 Percentage of participants	16.7 Percentage of participants	9.1 Percentage of participants	21.2 Percentage of participants	13.8 Percentage of participants
Percentage of Participants With Categorized Change From Baseline in ECG Parameters (QT, QTcB, QTcF) QT Interval: Normal QT change	70.8 Percentage of participants	66.7 Percentage of participants	68.8 Percentage of participants	66.7 Percentage of participants	57.6 Percentage of participants	58.6 Percentage of participants
Percentage of Participants With Categorized Change From Baseline in ECG Parameters (QT, QTcB, QTcF) QT Interval: Borderline QT change	25.0 Percentage of participants	29.2 Percentage of participants	27.1 Percentage of participants	27.3 Percentage of participants	33.3 Percentage of participants	37.9 Percentage of participants
Percentage of Participants With Categorized Change From Baseline in ECG Parameters (QT, QTcB, QTcF) QT Interval: Abnormally high QT change	4.2 Percentage of participants	4.2 Percentage of participants	4.2 Percentage of participants	6.1 Percentage of participants	9.1 Percentage of participants	3.4 Percentage of participants
Percentage of Participants With Categorized Change From Baseline in ECG Parameters (QT, QTcB, QTcF) QTcB Interval: Borderline QTc change	12.5 Percentage of participants	14.6 Percentage of participants	6.3 Percentage of participants	9.1 Percentage of participants	9.1 Percentage of participants	6.9 Percentage of participants
Percentage of Participants With Categorized Change From Baseline in ECG Parameters (QT, QTcB, QTcF) QTcF Interval: Abnormally high QTc change	0 Percentage of participants	2.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 28

Percentage of participants with vital signs (SBP,DBP, pulse rate, respiratory rate, body temperature and SpO2) abnormalities (abnormally low \[ABL\] and abnormally high \[ABH\]) were reported. DBP: ABL: \<35 mmHg:0-3 months (mths), \<40 mmHg:3 mths- \<3.5 years,ABH: \>65 mmHg:0-3 mths, \>85 mmHg:3-12 mths, \>90 mmHg:1-2 years, \>70 mmHg: 2- \<3.5 years; SBP:ABL: \<60 mmHg:0-12 mths,\<75 mmHg:1-2 years, \<80:2- \<3.5 years,ABH: \>110:0-12 mths, \>120 mmHg:1-2 years, \>10 mmHg:2- \<3.5 years; Pulse rate:ABL: \<80 bpm:0-3 mths, \<70 bpm:3 mths-12 mth,\<60 bpm:1-2 years, \<90 bpm:2- \<3.5 years,ABH: \>180 bpm:0-3 mths, \>150 bpm:3 mths-12 mths, \>140 bpm:1-2 years, \>130:2- \<3.5 years; Respiratory rate:ABL: \<25 bpm:0-3 mths, \<20 bpm: 3 mths-12 mths,\<18 bpm:1-2 years, \<20 bpm:2- \<3.5 years, ABH:\>70 bpm:0-3 mths, \>60 bpm:3 mths-12 mths, \>50 bpm:1-2 years, \>35 bpm:2- \<3.5 years; SpO2: ABL: \<92%: 0-\<3.5 years; Temperature (Celsius): ABH:\>37.8:Tympanic, \>38.0:forehead, oral, axillary, \>37.2:rectal.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=49 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=50 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Percentage of Participants With Vital Signs Abnormalities Respiratory rate: Abnormally Low	10.4 Percentage of Participants	12.2 Percentage of Participants	0.0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Vital Signs Abnormalities Systolic Blood Pressure (SBP): Abnormally Low	2.1 Percentage of Participants	2.0 Percentage of Participants	8.3 Percentage of Participants	12.1 Percentage of Participants	8.8 Percentage of Participants	9.7 Percentage of Participants
Percentage of Participants With Vital Signs Abnormalities SBP: Abnormally High	45.8 Percentage of Participants	42.9 Percentage of Participants	35.4 Percentage of Participants	18.2 Percentage of Participants	17.6 Percentage of Participants	12.9 Percentage of Participants
Percentage of Participants With Vital Signs Abnormalities Diastolic Blood Pressure (DBP): Abnormally Low	18.8 Percentage of Participants	8.2 Percentage of Participants	25.0 Percentage of Participants	15.2 Percentage of Participants	2.9 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Vital Signs Abnormalities DBP: Abnormally High	35.4 Percentage of Participants	28.6 Percentage of Participants	27.1 Percentage of Participants	9.1 Percentage of Participants	17.6 Percentage of Participants	6.5 Percentage of Participants
Percentage of Participants With Vital Signs Abnormalities Pulse rate: Abnormally High	27.1 Percentage of Participants	30.6 Percentage of Participants	27.1 Percentage of Participants	12.1 Percentage of Participants	20.6 Percentage of Participants	16.1 Percentage of Participants
Percentage of Participants With Vital Signs Abnormalities Pulse rate: Abnormally Low	2.1 Percentage of Participants	0.0 Percentage of Participants	0 Percentage of Participants	6.1 Percentage of Participants	5.9 Percentage of Participants	16.1 Percentage of Participants
Percentage of Participants With Vital Signs Abnormalities Respiratory rate: Abnormally High	12.5 Percentage of Participants	4.1 Percentage of Participants	18.8 Percentage of Participants	3.1 Percentage of Participants	2.9 Percentage of Participants	6.5 Percentage of Participants
Percentage of Participants With Vital Signs Abnormalities Temperature: Abnormally High	41.7 Percentage of Participants	30.6 Percentage of Participants	22.9 Percentage of Participants	50.0 Percentage of Participants	52.9 Percentage of Participants	54.8 Percentage of Participants
Percentage of Participants With Vital Signs Abnormalities Oxygen saturation: Abnormally Low	12.5 Percentage of Participants	8.2 Percentage of Participants	6.3 Percentage of Participants	3.1 Percentage of Participants	9.4 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: 0 to 24 hours post dose on Days 1 and 7

Population: PK analysis set included all participants from Cohort-1 who received JNJ-53718678 and for whom at least one PK concentration was reported. Here, 'n' (number analyzed) represents number of participants who were evaluable for specified timepoints.

AUC (0-24) is defined as area under the plasma concentration-time curve from timepoint 0 hours until 24 hours post dose estimated by population PK model.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=32 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=30 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Area Under the Plasma Concentration-Time Curve From Timepoint 0 Hours Until 24 Hours Post Dose (AUC[0-24 Hours]) >=28 days to <3 months: Day 1	20600 Nanogramshours per milliliter (ngh/mL) Standard Deviation 3990	6690 Nanogramshours per milliliter (ngh/mL) Standard Deviation 1950	—	—	—	—
Cohort 1: Area Under the Plasma Concentration-Time Curve From Timepoint 0 Hours Until 24 Hours Post Dose (AUC[0-24 Hours]) >=28 days to<3 months: Day 7	36000 Nanogramshours per milliliter (ngh/mL) Standard Deviation 8140	11400 Nanogramshours per milliliter (ngh/mL) Standard Deviation 3930	—	—	—	—
Cohort 1: Area Under the Plasma Concentration-Time Curve From Timepoint 0 Hours Until 24 Hours Post Dose (AUC[0-24 Hours]) >=3 months to <6 months: Day 1	23600 Nanogramshours per milliliter (ngh/mL) Standard Deviation 12500	5340 Nanogramshours per milliliter (ngh/mL) Standard Deviation 2670	—	—	—	—
Cohort 1: Area Under the Plasma Concentration-Time Curve From Timepoint 0 Hours Until 24 Hours Post Dose (AUC[0-24 Hours]) >=3 months to <6 months: Day 7	35000 Nanogramshours per milliliter (ngh/mL) Standard Deviation 20100	7370 Nanogramshours per milliliter (ngh/mL) Standard Deviation 4270	—	—	—	—
Cohort 1: Area Under the Plasma Concentration-Time Curve From Timepoint 0 Hours Until 24 Hours Post Dose (AUC[0-24 Hours]) >=6 months to <=3 years: Day 1	25000 Nanogramshours per milliliter (ngh/mL) Standard Deviation 11600	6910 Nanogramshours per milliliter (ngh/mL) Standard Deviation 2900	—	—	—	—
Cohort 1: Area Under the Plasma Concentration-Time Curve From Timepoint 0 Hours Until 24 Hours Post Dose (AUC[0-24 Hours]) >=6 months to <=3 years: Day 7	31000 Nanogramshours per milliliter (ngh/mL) Standard Deviation 16300	8160 Nanogramshours per milliliter (ngh/mL) Standard Deviation 3950	—	—	—	—

SECONDARY outcome

Timeframe: Days 1 and 7

Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=32 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=30 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Maximum Plasma Concentration (Cmax) of JNJ-53718678 >=28 days to <3 months: Day 1	1590 Nanograms per milliliter (ng/mL) Standard Deviation 345	531 Nanograms per milliliter (ng/mL) Standard Deviation 193	—	—	—	—
Cohort 1: Maximum Plasma Concentration (Cmax) of JNJ-53718678 >=28 days to <3 months: Day 7	2550 Nanograms per milliliter (ng/mL) Standard Deviation 550	843 Nanograms per milliliter (ng/mL) Standard Deviation 255	—	—	—	—
Cohort 1: Maximum Plasma Concentration (Cmax) of JNJ-53718678 >=3 months to <6 months: Day 1	2070 Nanograms per milliliter (ng/mL) Standard Deviation 1200	497 Nanograms per milliliter (ng/mL) Standard Deviation 256	—	—	—	—
Cohort 1: Maximum Plasma Concentration (Cmax) of JNJ-53718678 >=3 months to <6 months: Day 7	2920 Nanograms per milliliter (ng/mL) Standard Deviation 1500	691 Nanograms per milliliter (ng/mL) Standard Deviation 306	—	—	—	—
Cohort 1: Maximum Plasma Concentration (Cmax) of JNJ-53718678 >=6 months to <=3 years: Day 1	2720 Nanograms per milliliter (ng/mL) Standard Deviation 1040	846 Nanograms per milliliter (ng/mL) Standard Deviation 268	—	—	—	—
Cohort 1: Maximum Plasma Concentration (Cmax) of JNJ-53718678 >=6 months to <=3 years: Day 7	3560 Nanograms per milliliter (ng/mL) Standard Deviation 1330	1030 Nanograms per milliliter (ng/mL) Standard Deviation 310	—	—	—	—

SECONDARY outcome

Timeframe: Days 1 and 7

Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=32 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=30 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 1: Trough Plasma Concentration (Ctrough) of JNJ-53718678 >=28 days to <3 months: Day 1	167 ng/mL Standard Deviation 147	64 ng/mL Standard Deviation 31.3	—	—	—	—
Cohort 1: Trough Plasma Concentration (Ctrough) of JNJ-53718678 >=28 days to <3 months: Day 7	885 ng/mL Standard Deviation 239	267 ng/mL Standard Deviation 111	—	—	—	—
Cohort 1: Trough Plasma Concentration (Ctrough) of JNJ-53718678 >=3 months to <6 months: Day 1	204 ng/mL Standard Deviation 58.5	55.5 ng/mL Standard Deviation 33.5	—	—	—	—
Cohort 1: Trough Plasma Concentration (Ctrough) of JNJ-53718678 >=3 months to <6 months: Day 7	702 ng/mL Standard Deviation 487	126 ng/mL Standard Deviation 103	—	—	—	—
Cohort 1: Trough Plasma Concentration (Ctrough) of JNJ-53718678 >=6 months to <=3 years: Day 1	227 ng/mL Standard Deviation 149	59.9 ng/mL Standard Deviation 43	—	—	—	—
Cohort 1: Trough Plasma Concentration (Ctrough) of JNJ-53718678 >=6 months to <=3 years: Day 7	386 ng/mL Standard Deviation 331	89 ng/mL Standard Deviation 73.6	—	—	—	—

SECONDARY outcome

Timeframe: Once daily dosing: Day 3 and Day 8 pre- or post-dose. Twice daily dosing: Day 1 at least 1 hour post-dose, and Days 3 or 5 (combined in one timepoint) at least 4 hours after morning dose but prior to evening dose

Population: PK analysis set included all participants from Cohort-2 who received JNJ-53718678 and for whom at least one PK concentration was reported. Here, 'n' (number analyzed) represents number of participants who were evaluable at specified timepoints.

Plasma concentration of JNJ-53718678 was measured for Cohort-2. As per planned analysis in the protocol, PK sampling was performed on either Day 3 or Day 5 for participants receiving twice daily dosing, resulting in one combined timepoint of Day 3 or Day 5. Hence, the data collected on either Day 3 or Day 5 was pooled and is reported here collectively.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=30 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=33 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Cohort 2: Plasma Concentration of JNJ-53718678 Day 3 (Once daily)	931.66 ng/mL Standard Deviation 1757.958	392.97 ng/mL Standard Deviation 638.253	—	—	—	—
Cohort 2: Plasma Concentration of JNJ-53718678 Day 8 (Once daily)	364.73 ng/mL Standard Deviation 951.896	59.05 ng/mL Standard Deviation 84.552	—	—	—	—
Cohort 2: Plasma Concentration of JNJ-53718678 Day 1 (Twice daily)	1539.43 ng/mL Standard Deviation 602.591	394.58 ng/mL Standard Deviation 297.539	—	—	—	—
Cohort 2: Plasma Concentration of JNJ-53718678 Day 3 or Day 5 (Twice daily)	1050.44 ng/mL Standard Deviation 663.166	441.13 ng/mL Standard Deviation 305.450	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 28

Percentage of participants with MRU (any medical care encounters) was reported.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=47 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=47 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=44 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=32 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=33 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=28 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Percentage of Participants With Medical Resource Utilization (MRU)	100.0 Percentage of Participants	100.0 Percentage of Participants	100.0 Percentage of Participants	9.4 Percentage of Participants	15.2 Percentage of Participants	25.0 Percentage of Participants

SECONDARY outcome

Timeframe: Day 8

Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Percentage of participants with acceptability and palatability of the JNJ-53718678 formulation was assessed through a questionnaire asking about the child's reaction when given the medicine, completed by parent(s)/caregiver(s) after last dosing that categorized as 1) child took medicine easily, 2) disgusted expressions after tasting medicine, 3) cried after tasting medicine, 4) would not open mouth or turned head away to avoid medicine, 5) spit out or coughed out medicine, 6) gagged, and 7) vomited (within 2 minutes of swallowing medicine). Below results are based on response to "child took medicine easily".

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=32 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=34 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=37 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=24 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=21 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=21 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Percentage of Participants With Acceptability and Palatability of the JNJ-53718678 Formulation as Assessed by Parent(s)/Caregiver(s)	84.4 Percentage of Participants	67.6 Percentage of Participants	73.0 Percentage of Participants	70.8 Percentage of Participants	90.5 Percentage of Participants	85.7 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 21

Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Number of participants with emerging variations in the viral genome potentially associated with resistance to JNJ-53718678 was reported. Number of participants with F gene sequencing data available and with emerging genetic variations post-baseline as compared to baseline, considering 24 RSV F protein positions of interest (positions 127, 137, 138, 140, 141, 143, 144, 323, 338, 339, 392, 394, 396, 397, 398, 399, 400, 401, 474, 486, 487, 488, 489, and 517) was reported.

Outcome measures

Outcome measures
Measure	Cohort 1: JNJ-53718678 Low Dose n=43 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: Placebo n=44 Participants Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=40 Participants Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=32 Participants As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=29 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=28 Participants As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Number of Participants With Emerging Variations in the Viral Genome Potentially Associated With Resistance to JNJ-53718678	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants

Adverse Events

Cohort 1: Placebo

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

Cohort 1: JNJ-53718678 Low Dose

Serious events: 5 serious events

Other events: 29 other events

Deaths: 0 deaths

Cohort 1: JNJ-53718678 High Dose

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Cohort 2: Placebo

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Cohort 2: JNJ-53718678 Low Dose

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Cohort 2: JNJ-53718678 High Dose

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Placebo n=50 participants at risk Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 Low Dose n=49 participants at risk Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 participants at risk Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 participants at risk As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 participants at risk As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 participants at risk As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Infections and infestations Bronchiolitis	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Bronchitis	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Coronavirus Infection	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Gastroenteritis	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Influenza	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Pneumonia	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Pneumonia Respiratory Syncytial Viral	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Respiratory Syncytial Virus Bronchiolitis	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Respiratory Tract Infection	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Metabolism and nutrition disorders Feeding Disorder	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	4.0% 2/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Wheezing	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.

Other adverse events

Other adverse events
Measure	Cohort 1: Placebo n=50 participants at risk Participants of age groups (age group 1: greater than or equal to \[\>=\] 28 days to less than \[\<\] 3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to less than or equal to \[\<=\] 3 years), who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days.	Cohort 1: JNJ-53718678 Low Dose n=49 participants at risk Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 1.7 milligrams per kilogram (mg/kg) for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 1: JNJ-53718678 High Dose n=48 participants at risk Participants who were hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital received JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days.	Cohort 2: Placebo n=34 participants at risk As per the original dosing, outpatients of age groups (age group 1: \>=28 days to \<3 months, age group 2: \>=3 months to \<6 months, and age group 3: \>=6 months to \<=3 years) were randomized to receive placebo matching to JNJ-53718678 (high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose, respectively) orally once daily for 7 days. After protocol amendment 4, participants received placebo matching to JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.	Cohort 2: JNJ-53718678 Low Dose n=34 participants at risk As per the original dosing, outpatients were randomized to receive JNJ-53718678 1.7 mg/kg for age group 1: \>=28 days to \<3 months; 2 mg/kg for age group 2: \>=3 months to \<6 months; and 3 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 0.85 mg/kg for age group 1, JNJ-53718678 1.0 mg/kg for age group 2, and JNJ-53718678 1.5 mg/kg for age group 3, orally twice daily for 7 days.	Cohort 2: JNJ-53718678 High Dose n=31 participants at risk As per the original dosing, outpatients were randomized to receive JNJ-53718678 5 mg/kg for age group 1: \>=28 days to \<3 months; 6 mg/kg for age group 2: \>=3 months to \<6 months; and 9 mg/kg for age group 3: \>=6 months to \<=3 years, orally once daily for 7 days. After protocol amendment 4, participants were randomized to receive JNJ-53718678 2.5 mg/kg for age group 1, JNJ-53718678 3.0 mg/kg for age group 2, and JNJ-53718678 4.5 mg/kg for age group 3, orally twice daily for 7 days.
Blood and lymphatic system disorders Anaemia	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	4.1% 2/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Blood and lymphatic system disorders Leukopenia	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Blood and lymphatic system disorders Lymphadenopathy	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Blood and lymphatic system disorders Lymphocytosis	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Blood and lymphatic system disorders Neutropenia	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	4.2% 2/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Blood and lymphatic system disorders Thrombocytosis	4.0% 2/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	4.1% 2/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	6.2% 3/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	5.9% 2/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Eye disorders Eye Discharge	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Eye disorders Ocular Hyperaemia	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Gastrointestinal disorders Anal Erythema	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Gastrointestinal disorders Anorectal Discomfort	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Gastrointestinal disorders Constipation	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Gastrointestinal disorders Diarrhoea	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	4.1% 2/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	10.4% 5/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	14.7% 5/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	8.8% 3/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	12.9% 4/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Gastrointestinal disorders Faeces Soft	6.0% 3/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	4.2% 2/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Gastrointestinal disorders Noninfective Gingivitis	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Gastrointestinal disorders Post-Tussive Vomiting	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Gastrointestinal disorders Vomiting	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	6.1% 3/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	6.2% 3/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	11.8% 4/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
General disorders Face Oedema	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
General disorders Hyperthermia	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
General disorders Oedema Peripheral	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
General disorders Pyrexia	4.0% 2/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	6.1% 3/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	6.2% 3/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Hepatobiliary disorders Hepatosplenomegaly	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Hepatobiliary disorders Hypertransaminasaemia	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Bronchiolitis	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Bronchitis	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Candida Nappy Rash	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Conjunctivitis	4.0% 2/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	4.1% 2/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Ear Infection	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Exanthema Subitum	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Fungal Infection	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Gastroenteritis	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	4.1% 2/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	4.2% 2/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Hand-Foot-And-Mouth Disease	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	4.1% 2/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Influenza	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	5.9% 2/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Localised Infection	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Lower Respiratory Tract Infection Bacterial	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Nasopharyngitis	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	4.1% 2/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	12.5% 6/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	5.9% 2/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Oral Candidiasis	4.0% 2/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	4.1% 2/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Otitis Media	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Otitis Media Acute	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	4.1% 2/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Parainfluenzae Virus Infection	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Pneumonia	4.0% 2/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Pneumonia Bacterial	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Respiratory Tract Infection	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Respiratory Tract Infection Bacterial	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Respiratory Tract Infection Viral	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Rhinovirus Infection	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Sinusitis	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Tonsillitis	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Upper Respiratory Tract Infection	8.0% 4/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	6.1% 3/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Urinary Tract Infection	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	4.1% 2/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Viral Infection	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Infections and infestations Viral Rash	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Injury, poisoning and procedural complications Arthropod Sting	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Injury, poisoning and procedural complications Contusion	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Injury, poisoning and procedural complications Head Injury	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Injury, poisoning and procedural complications Radial Head Dislocation	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Injury, poisoning and procedural complications Skin Wound	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Investigations Alanine Aminotransferase Increased	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Investigations Aspartate Aminotransferase Increased	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Investigations Blood Creatinine Increased	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Investigations Blood Potassium Increased	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Investigations Oxygen Saturation Decreased	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Investigations Platelet Count Increased	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Investigations Transaminases Increased	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Metabolism and nutrition disorders Hyperkalaemia	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Metabolism and nutrition disorders Hyperuricaemia	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Metabolism and nutrition disorders Metabolic Alkalosis	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Metabolism and nutrition disorders Zinc Deficiency	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Psychiatric disorders Restlessness	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Renal and urinary disorders Oliguria	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Renal and urinary disorders Polyuria	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Atelectasis	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Bronchial Obstruction	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Bronchial Secretion Retention	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Bronchospasm	4.0% 2/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Cough	4.0% 2/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Dysphonia	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Lung Consolidation	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Nasal Discomfort	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Respiratory Depth Increased	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	4.0% 2/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Sinus Disorder	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Congestion	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Inflammation	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Skin and subcutaneous tissue disorders Asteatosis	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Skin and subcutaneous tissue disorders Dermatitis Diaper	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	6.2% 3/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	3.2% 1/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Skin and subcutaneous tissue disorders Rash	6.0% 3/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	6.2% 3/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	5.9% 2/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Skin and subcutaneous tissue disorders Rash Erythematous	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.0% 1/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Skin and subcutaneous tissue disorders Rash Macular	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Skin and subcutaneous tissue disorders Rash Papular	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.9% 1/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Skin and subcutaneous tissue disorders Skin Lesion	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Skin and subcutaneous tissue disorders Urticaria	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Vascular disorders Haematoma	2.0% 1/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.
Vascular disorders Hyperaemia	0.00% 0/50 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/49 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	2.1% 1/48 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/34 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.	0.00% 0/31 • Up to Day 28 The Safety analysis set included all participants who received at least 1 dose of study agent, and were analyzed as treated, regardless of the randomized treatment group assigned.

Additional Information

Senior Director Medical Leader

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER