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

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ-53718678
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Infections

Eligibility Criteria

28 Days - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent form (ICF) must be given
  • Laboratory diagnosis of respiratory syncytial virus (RSV) infection
  • The participant has an acute respiratory illness
  • The time of onset of RSV symptoms to the anticipated time of randomization must be less than or equal to (<=) 5 days
  • Except for the RSV-related illness, the Participant must be medically stable in case of allowed co-morbid conditions
  • The participant must have been assessed per local public health practice and considered not to have Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during this respiratory infection

Exclusion Criteria:

  • The participant is less than (<) 3 months postnatal age at screening and was born prematurely (i.e, <37 weeks and 0 days of gestation) OR if the participant weighs <2.4 kilogram (kg) or greater than (>) 16.8 kg
  • Participant is considered by the investigator to be immunocompromised within the past 12 months
  • Participant unwilling or unable to undergo mid-turbinate nasal swab procedures
  • Participant is receiving chronic home oxygen therapy at screening
  • Participant has other clinically significant abnormal electrocardiogram (ECG) findings not consistent with the present risk factor for severe RSV disease (if applicable) in the study population, as judged by the investigator based on the machine read ECG results at screening
  • The participant has a QTcF interval greater than (>)450 millisecond (ms) per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate ECG recording during screening

Sites / Locations

  • Madera Family Medical Group
  • FOMAT Medical Research
  • Children's Hospital Colorado
  • Elite Clinical Trials
  • Saltzer Medical Group
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Tufts Medical Center
  • Craig A. Spiegel, MD
  • SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH)
  • Santiago Reyes, MD
  • Coastal Pediatric Research
  • Sanford Health
  • Children's Hospital of Richmond at VCU
  • West Virginia University
  • Hospital Italiano Regional Del Sur
  • Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
  • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
  • Hospital Pedro de Elizalde
  • Fundación Respirar
  • Hospital Italiano de La Plata
  • Hospital Universitario Austral
  • Clinica Mayo de UMCB
  • Hospital del Niño Jesús
  • ULB Hôpital Erasme
  • UZ Antwerpen
  • C.H.R. Citadelle
  • Universidade Federal De Minas Gerais - Hospital das Clínicas
  • Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
  • Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro
  • Nucleo de Pesquisa do Hospital Pequeno Princípe
  • Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
  • Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN
  • Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
  • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Associacao Hospitalar Moinhos de Vento
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
  • Fundacao Jose Luiz Egydio Setubal
  • CMPC - Consultoria Médica e Pesquisa Clínica
  • Santa Casa de Misericórdia de Votuporanga
  • UMHAT 'Dr. Georgi Stranski', EAD
  • UMHAT 'Sveti Georgi'-Plovdiv
  • UMHAT 'Kanev' EAD
  • Medical Center-1-Sevlievo EOOD
  • Acibadem City Clinic Tokuda Hospital
  • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
  • UMHAT 'Aleksandrovska' EAD
  • SHATCD 'Prof. Ivan Mitev' EAD
  • CHU de Caen
  • Hopital Antoine Beclere
  • CHU de Montpellier - Arnaud de Villeneuve
  • CHU de Nantes hôtel-Dieu
  • Hopitaux pediatriques CHU Lenval
  • Hôpital Necker-Enfants Malades
  • Hopital Charles Nicolle
  • Kinderarztpraxis Bramsche
  • Hürthpark Kinder & Jugendärzte
  • Praxiszentrum Triftplatz
  • Kinderärztliche Gemeinschaftspraxis
  • Universitätsklinikum Würzburg
  • Semmelweis Egyetem, II. sz. Gyermekgyógyászati Klinika
  • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely
  • Debreceni Egyetem Klinikai Központ,Infektológiai Klinika
  • Debreceni Egyetem Klinikai Kozpont
  • Futurenest Klinikai Kutato Kft.
  • Kanizsai Dorottya Kórház
  • Szegedi Tudomanyegyetem
  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
  • Csolnoky Ferenc Korhaz
  • A.O.U Sant'Orsola-Malpighi
  • ASST Fatebenefratelli Sacco / Ospedale dei Bambini V. Buzzi
  • Dipartimento di Pediatria dell'Ospedale Luigi Sacco
  • Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Azienda Ospedaliera di Padova
  • Department of Pediatrics University of Pavia, Policlinico San Matteo
  • Ospedale degli Infermi
  • Hosaka Kodomo Clinic
  • Kobayashi Pediatric Clinic
  • Fukui-ken Saiseikai Hospital
  • National Hospital Organization Fukuyama Medical Center
  • Fukuyama City Hospital
  • Tanabe Pediatrics Clinic
  • Kagoshima Children's Hospital
  • National Hospital Organization Hirosaki General Medical Center
  • Shirao Clinic of Pediatrics and Pediatric Allergy
  • National Hospital Organization Kanazawa Medical Center
  • Daido Hospital
  • Kojunkai Daido Clinic
  • National Hospital Organization Beppu Medical Center
  • Momotaro Clinic
  • National Hospital Organization Saitama National Hospital
  • KKR Sapporo Medical Center
  • Tsuda Pediatrics Clinic
  • Okawa Children & Family Clinic
  • INAMI Pediatric clinic
  • The Catholic University of Korea, Incheon St. Mary's Hospital
  • Nowon Eulji Medical Center, Eulji University
  • Kangbuk Samsung Hospital
  • Inje University Sanggye Paik Hospital
  • Hospital Selayang
  • Hospital Miri
  • Hospital Tuanku Fauziah
  • Hospital Sibu
  • RM Pharma Specialists
  • Hospital Infantil de Mexico Federico Gomez
  • Instituto Nacional de Pediatría
  • Hospital Civil de Guadalajara
  • Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
  • Osrodek Badan Klinicznych In-Vivo Sp. z o.o.
  • Zespol Opieki Zdrowotnej w Debicy, Oddzial Dzieciecy
  • Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddzial Pediatrii i Neurologii Dzieciecej
  • NZOZ Salmed
  • Instytut Gruzlicy i Chorob Pluc Oddzial Terenowy im. Rudnikow w Rabce-Zdroj, Oddzial Pulmonologii
  • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o.o.
  • Szpital im. Swietej Jadwigi Slaskiej, Oddział Pediatryczny z Pododdziałem Niemowlęcym
  • Infectious Clinical Hospital #1 Of The Moscow City Health Department
  • OOO MDP-Medical Group
  • City Children Clinical Outpatient Clinic #5
  • OOO 'Medical Technologies'
  • Children Outpatient Clinic 45 Of Nevskiy Region
  • OOO 'Arsvite North-West'
  • LLC Pitercliniсa
  • LLC Kurator
  • Siberian State Medical University
  • Bashkir State Medical University
  • Yaroslavl State Medical University Based On Children Polyclinics #5
  • Tygrberg Hospital
  • Josha Research
  • VX Pharma
  • Two Military Hospital
  • Hosp. Univ. Germans Trias I Pujol
  • Hosp. Del Mar
  • Hosp. Univ. de Burgos
  • Hosp. Univ. de Getafe
  • Hosp. Univ. Fund. Jimenez Diaz
  • Hosp. Univ. 12 de Octubre
  • Hosp. Univ. La Paz
  • Hosp. Univ. Pta. de Hierro Majadahonda
  • Hosp. Regional Univ. de Malaga
  • Hosp. Puerta Del Sur
  • Hosp. Quiron Madrid Pozuelo
  • Hosp. Clinico Univ. de Salamanca
  • Hosp. Clinico Univ. de Santiago
  • Barn- Och Ungdomsmedicin
  • Sachsska barn-och ungdomssjukhuset
  • Astrid Lindgrens barnsjukhus Solna
  • Hsinchu MacKay Memorial Hospital
  • Kaohsiung Chang Gung Memorial Hospital
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Taipei Municipal Wanfang Hospital
  • Chang Gung Memorial Hospital- Linkou
  • Queen Sirikit National Institute of Child Health
  • Tropical Medicine Hospital, Mahidol University
  • Siriraj Hospital Mahidol University
  • Chiang Mai University
  • Research Institute for Health Sciences
  • Srinagarind Hospital
  • Cukurova University Medical Faculty Balcali Hospital
  • Ankara University Medical Faculty
  • Hacettepe University Medical Faculty
  • Gazi University Medical Faculty
  • Ankara Bilkent Sehir Hastanesi
  • Istanbul University Istanbul Medical Faculty
  • Ege University Medical Faculty
  • Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital
  • Karadeniz Teknik University Medical Faculty
  • Royal Devon & Exeter Hospital
  • Whipps Cross University Hospital
  • The Adam Practice

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High Dose: JNJ-53718678

Low Dose: JNJ-53718678

Placebo

Arm Description

Participants will be randomized to receive JNJ-53718678 2.5 milligram per kilogram (mg/kg) (Age Group 1: greater than or equal to [>=] 28 days and less than [<] 3 months of age), 3 mg/kg (Age Group 2: >=3 months and <6 months of age) and 4.5 mg/kg (Age Group 3: >=6 months and less than or equal to [<=3] years of age) orally twice daily for 7 days.

Participants will be randomized to receive JNJ-53718678 0.85 mg/kg (Age Group 1: >=28 days and <3 months of age), 1 mg/kg (Age Group 2: >=3 months and <6 months of age) and 1.5 mg/kg (Age Group 3: >=6 months and 3 years of age) orally twice daily for 7 days.

Participants will be randomized to receive matching placebo (i.e. high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose) orally twice daily for 7 days.

Outcomes

Primary Outcome Measures

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])
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.

Secondary Outcome Measures

RSV Viral Load Over Time
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.
Change From Baseline in RSV Viral Load Over Time
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.
Least Squares (LS) Mean RSV Viral Load on 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.
Time to Undetectable RSV Viral Load
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.
Percentage of Participants With Undetectable RSV Viral Load at Each Timepoint Throughout the Study
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.
Change From Baseline in Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcomes Rating System (PRESORS) Scores
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.
Change From Baseline in Clinician PRESORS Score
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.
Time to Resolution of RSV Symptoms Based on PRESORS Caregiver (ObsRO)
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.
Time to Improvement on Overall Health
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'.
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time
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.
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time
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.
Percentage of Participants With Worsening or Improvement Status of RSV Disease
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".
Percentage of Participants by Return to Pre-RSV Disease Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time
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'.
Respiratory Rate (RR) Over Time
Respiratory rate (RR) was measured by the investigator over time.
Change From Baseline in Respiratory Rate
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.
Heart Rate Over Time
Heart rate was measured by the investigator over time.
Change From Baseline in Heart Rate
Change from baseline in heart rate was assessed.
Body Temperature Over Time
Body temperature was reported over time (either investigator or caregiver measured).
Change From Baseline in Body Temperature
Change from baseline in body temperature (either investigator or caregiver measured) was assessed.
Peripheral Capillary Oxygen Saturation (SpO2) Over Time
Peripheral capillary oxygen saturation was measured by the investigator over time.
Change From Baseline in Peripheral Capillary Oxygen Saturation (SpO2)
Change from baseline in peripheral capillary oxygen saturation levels was derived based on reported values over time.
Percentage of Participants Who Required (re)Hospitalization During Treatment and Follow-up
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).
Cohort 1: Time to Return to Age-adjusted Normal Values for Vital Signs
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.
Cohort 1: Time to Discharge From Hospital
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.
Cohort 1: Percentage of Participants Who Required Admission to the Intensive Care Unit (ICU)
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.
Cohort 1: Duration of ICU Stay
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.
Cohort 1: Time to Clinical Stability Evaluated by the Investigator
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.
Cohort 1: Percentage of Participants Who Required Supplemental Oxygen
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.
Cohort 1: Duration of Supplemental Oxygen
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.
Cohort 1: Percentage of Participants Who Required Non-invasive Mechanical Ventilation Support
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.
Cohort 1: Percentage of Participants Who Required Invasive Mechanical Ventilation Support
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.
Cohort 1: Percentage of Participants Who Required Non-invasive Non-mechanical Ventilation Support
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.
Cohort 1: Duration of Non-invasive Ventilation Support
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.
Cohort 1: Duration of Invasive Ventilation Support
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.
Cohort 1: Time to End of Supplemental Oxygen up to 72 Hours From First Hospital Discharge
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.
Cohort 1: Percentage of Participants Who Needed Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube
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.
Percentage of Participants With Adverse Events
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.
Percentage of Participants With Abnormal Laboratory Findings
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.
Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
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.
Percentage of Participants With Categorized Change From Baseline in ECG Parameters (QT, QTcB, QTcF)
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.
Percentage of Participants With Vital Signs Abnormalities
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.
Cohort 1: Area Under the Plasma Concentration-Time Curve From Timepoint 0 Hours Until 24 Hours Post Dose (AUC[0-24 Hours])
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.
Cohort 1: Maximum Plasma Concentration (Cmax) of JNJ-53718678
Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model.
Cohort 1: Trough Plasma Concentration (Ctrough) of JNJ-53718678
Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model.
Cohort 2: Plasma Concentration of JNJ-53718678
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.
Percentage of Participants With Medical Resource Utilization (MRU)
Percentage of participants with MRU (any medical care encounters) was reported.
Percentage of Participants With Acceptability and Palatability of the JNJ-53718678 Formulation as Assessed by Parent(s)/Caregiver(s)
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".
Number of Participants With Emerging Variations in the Viral Genome Potentially Associated With Resistance to JNJ-53718678
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.

Full Information

First Posted
August 15, 2018
Last Updated
September 19, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03656510
Brief Title
Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection
Official Title
A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children >=28 Days and <=3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Janssen made the strategic decision to discontinue the CROCuS study. This decision is not based on any safety concerns.
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
April 18, 2022 (Actual)
Study Completion Date
April 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants [Cohort 1] or outpatients [Cohort 2]).
Detailed Description
JNJ-53718678 is an investigational respiratory syncytial virus (RSV) specific fusion inhibitor and is under development for the treatment of RSV infection, which results in an upper and/or lower respiratory tract illness. The primary hypothesis of this study is that JNJ-53718678 has antiviral activity against RSV (that is, results in a decrease in RSV nasal viral load from immediately prior to first dose of study drug until Day 5). This will be assessed by a positive dose-response relationship of JNJ-53718678 compared to placebo. Besides the RSV nasal viral load through day 5, other timepoints will also be evaluated as well as other nasal viral load related parameters. In addition, the evolution of signs and symptoms of RSV disease will be evaluated. Participants' safety will be monitored throughout the study by evaluating the occurrence and severity of adverse events and by laboratory and electrocardiogram measurements. Study participants will be identified when they are hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital (Cohort 1) or present for medical care as outpatients (Cohort 2) with symptoms of an acute respiratory illness supporting a diagnosis of RSV infection. Eligible participants will be randomized 1:1:1 to receive either a low or a high dose of JNJ 53718678 or placebo and will be receiving study treatment for 7 days. They will be followed up for 3 weeks after the last dose. The total study duration for each participant will be approximately 29 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Dose: JNJ-53718678
Arm Type
Experimental
Arm Description
Participants will be randomized to receive JNJ-53718678 2.5 milligram per kilogram (mg/kg) (Age Group 1: greater than or equal to [>=] 28 days and less than [<] 3 months of age), 3 mg/kg (Age Group 2: >=3 months and <6 months of age) and 4.5 mg/kg (Age Group 3: >=6 months and less than or equal to [<=3] years of age) orally twice daily for 7 days.
Arm Title
Low Dose: JNJ-53718678
Arm Type
Experimental
Arm Description
Participants will be randomized to receive JNJ-53718678 0.85 mg/kg (Age Group 1: >=28 days and <3 months of age), 1 mg/kg (Age Group 2: >=3 months and <6 months of age) and 1.5 mg/kg (Age Group 3: >=6 months and 3 years of age) orally twice daily for 7 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to receive matching placebo (i.e. high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose) orally twice daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
JNJ-53718678
Intervention Description
Participants will receive JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo (high volume or low volume) orally twice daily for 7 days.
Primary Outcome Measure Information:
Title
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])
Description
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.
Time Frame
Baseline through Day 5
Secondary Outcome Measure Information:
Title
RSV Viral Load Over Time
Description
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.
Time Frame
Baseline, Days 3, 5, 8, 14, and 21
Title
Change From Baseline in RSV Viral Load Over Time
Description
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.
Time Frame
Baseline up to Days 3, 5, 8, 14, and 21
Title
Least Squares (LS) Mean RSV Viral Load on Days 3, 8 and 14
Description
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.
Time Frame
Baseline through Days 3, 8, and 14
Title
Time to Undetectable RSV Viral Load
Description
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.
Time Frame
Up to Day 21
Title
Percentage of Participants With Undetectable RSV Viral Load at Each Timepoint Throughout the Study
Description
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.
Time Frame
Baseline, Days 3, 5, 8, 14 and 21
Title
Change From Baseline in Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcomes Rating System (PRESORS) Scores
Description
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.
Time Frame
Baseline up to Days 3, 5, 8, 14 and 21
Title
Change From Baseline in Clinician PRESORS Score
Description
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.
Time Frame
Baseline, up to Days 3, 5, 8, 14 and 21
Title
Time to Resolution of RSV Symptoms Based on PRESORS Caregiver (ObsRO)
Description
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.
Time Frame
Up to Day 21
Title
Time to Improvement on Overall Health
Description
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'.
Time Frame
Up to Day 21
Title
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time
Description
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.
Time Frame
Baseline, Days 3, 5, 8, 14, and 21
Title
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time
Description
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.
Time Frame
Baseline, Days 3, 5, 8, 14, and 21
Title
Percentage of Participants With Worsening or Improvement Status of RSV Disease
Description
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".
Time Frame
Days 14 and 21
Title
Percentage of Participants by Return to Pre-RSV Disease Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time
Description
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'.
Time Frame
Baseline, Days 3, 5, 8, 14, and 21
Title
Respiratory Rate (RR) Over Time
Description
Respiratory rate (RR) was measured by the investigator over time.
Time Frame
Baseline, Days 3, 5, 8, 14 and 21
Title
Change From Baseline in Respiratory Rate
Description
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.
Time Frame
Baseline to Days 3, 5, 8, 14 and 21
Title
Heart Rate Over Time
Description
Heart rate was measured by the investigator over time.
Time Frame
Baseline, Days 3, 5, 8, 14 and 21
Title
Change From Baseline in Heart Rate
Description
Change from baseline in heart rate was assessed.
Time Frame
Baseline to Days 3, 5, 8, 14 and 21
Title
Body Temperature Over Time
Description
Body temperature was reported over time (either investigator or caregiver measured).
Time Frame
Baseline, Days 3, 5, 8, 14 and 21
Title
Change From Baseline in Body Temperature
Description
Change from baseline in body temperature (either investigator or caregiver measured) was assessed.
Time Frame
Baseline to Days 3, 5, 8, 14 and 21
Title
Peripheral Capillary Oxygen Saturation (SpO2) Over Time
Description
Peripheral capillary oxygen saturation was measured by the investigator over time.
Time Frame
Baseline, Days 3, 5, 8, 14 and 21
Title
Change From Baseline in Peripheral Capillary Oxygen Saturation (SpO2)
Description
Change from baseline in peripheral capillary oxygen saturation levels was derived based on reported values over time.
Time Frame
Baseline to Days 3, 5, 8, 14, and 21
Title
Percentage of Participants Who Required (re)Hospitalization During Treatment and Follow-up
Description
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).
Time Frame
Up to Day 28
Title
Cohort 1: Time to Return to Age-adjusted Normal Values for Vital Signs
Description
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.
Time Frame
Up to Day 28
Title
Cohort 1: Time to Discharge From Hospital
Description
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.
Time Frame
Up to Day 28
Title
Cohort 1: Percentage of Participants Who Required Admission to the Intensive Care Unit (ICU)
Description
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.
Time Frame
Up to Day 21
Title
Cohort 1: Duration of ICU Stay
Description
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.
Time Frame
Up to Day 21
Title
Cohort 1: Time to Clinical Stability Evaluated by the Investigator
Description
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.
Time Frame
Up to Day 21
Title
Cohort 1: Percentage of Participants Who Required Supplemental Oxygen
Description
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.
Time Frame
Up to Day 21
Title
Cohort 1: Duration of Supplemental Oxygen
Description
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.
Time Frame
Up to Day 28
Title
Cohort 1: Percentage of Participants Who Required Non-invasive Mechanical Ventilation Support
Description
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.
Time Frame
Up to Day 21
Title
Cohort 1: Percentage of Participants Who Required Invasive Mechanical Ventilation Support
Description
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.
Time Frame
Up to Day 21
Title
Cohort 1: Percentage of Participants Who Required Non-invasive Non-mechanical Ventilation Support
Description
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.
Time Frame
Up to Day 21
Title
Cohort 1: Duration of Non-invasive Ventilation Support
Description
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.
Time Frame
Up to Day 21
Title
Cohort 1: Duration of Invasive Ventilation Support
Description
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.
Time Frame
Up to Day 21
Title
Cohort 1: Time to End of Supplemental Oxygen up to 72 Hours From First Hospital Discharge
Description
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.
Time Frame
Up to end of supplemental oxygen including supplemental oxygen within 72 hours after first hospital discharge (up to Day 28)
Title
Cohort 1: Percentage of Participants Who Needed Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube
Description
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.
Time Frame
Up to Day 28
Title
Percentage of Participants With Adverse Events
Description
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.
Time Frame
Up to Day 28
Title
Percentage of Participants With Abnormal Laboratory Findings
Description
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.
Time Frame
Up to Day 28
Title
Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
Description
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.
Time Frame
Up to Day 28
Title
Percentage of Participants With Categorized Change From Baseline in ECG Parameters (QT, QTcB, QTcF)
Description
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.
Time Frame
Baseline to Day 28
Title
Percentage of Participants With Vital Signs Abnormalities
Description
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.
Time Frame
Up to Day 28
Title
Cohort 1: Area Under the Plasma Concentration-Time Curve From Timepoint 0 Hours Until 24 Hours Post Dose (AUC[0-24 Hours])
Description
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.
Time Frame
0 to 24 hours post dose on Days 1 and 7
Title
Cohort 1: Maximum Plasma Concentration (Cmax) of JNJ-53718678
Description
Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model.
Time Frame
Days 1 and 7
Title
Cohort 1: Trough Plasma Concentration (Ctrough) of JNJ-53718678
Description
Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model.
Time Frame
Days 1 and 7
Title
Cohort 2: Plasma Concentration of JNJ-53718678
Description
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.
Time Frame
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
Title
Percentage of Participants With Medical Resource Utilization (MRU)
Description
Percentage of participants with MRU (any medical care encounters) was reported.
Time Frame
Up to Day 28
Title
Percentage of Participants With Acceptability and Palatability of the JNJ-53718678 Formulation as Assessed by Parent(s)/Caregiver(s)
Description
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".
Time Frame
Day 8
Title
Number of Participants With Emerging Variations in the Viral Genome Potentially Associated With Resistance to JNJ-53718678
Description
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.
Time Frame
Up to Day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent form (ICF) must be given Laboratory diagnosis of respiratory syncytial virus (RSV) infection The participant has an acute respiratory illness The time of onset of RSV symptoms to the anticipated time of randomization must be less than or equal to (<=) 5 days Except for the RSV-related illness, the Participant must be medically stable in case of allowed co-morbid conditions The participant must have been assessed per local public health practice and considered not to have Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during this respiratory infection Exclusion Criteria: The participant is less than (<) 3 months postnatal age at screening and was born prematurely (i.e, <37 weeks and 0 days of gestation) OR if the participant weighs <2.4 kilogram (kg) or greater than (>) 16.8 kg Participant is considered by the investigator to be immunocompromised within the past 12 months Participant unwilling or unable to undergo mid-turbinate nasal swab procedures Participant is receiving chronic home oxygen therapy at screening Participant has other clinically significant abnormal electrocardiogram (ECG) findings not consistent with the present risk factor for severe RSV disease (if applicable) in the study population, as judged by the investigator based on the machine read ECG results at screening The participant has a QTcF interval greater than (>)450 millisecond (ms) per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate ECG recording during screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Madera Family Medical Group
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
FOMAT Medical Research
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Elite Clinical Trials
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Saltzer Medical Group
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Craig A. Spiegel, MD
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH)
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Santiago Reyes, MD
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Coastal Pediatric Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Facility Name
Sanford Health
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Children's Hospital of Richmond at VCU
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Hospital Italiano Regional Del Sur
City
Bahía Blanca
ZIP/Postal Code
B8001HXM
Country
Argentina
Facility Name
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
City
Buenos Aires
ZIP/Postal Code
C1426BOS
Country
Argentina
Facility Name
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
City
City of Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Hospital Pedro de Elizalde
City
City of Buenos Aires
ZIP/Postal Code
C1270AAN
Country
Argentina
Facility Name
Fundación Respirar
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Hospital Italiano de La Plata
City
Ciudad De La Plata
ZIP/Postal Code
B1900AX
Country
Argentina
Facility Name
Hospital Universitario Austral
City
Pilar
ZIP/Postal Code
1629
Country
Argentina
Facility Name
Clinica Mayo de UMCB
City
San Miguel de Tucuman
ZIP/Postal Code
T4000IHE
Country
Argentina
Facility Name
Hospital del Niño Jesús
City
San Miguel de Tucumán
ZIP/Postal Code
4000
Country
Argentina
Facility Name
ULB Hôpital Erasme
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
C.H.R. Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Universidade Federal De Minas Gerais - Hospital das Clínicas
City
Belo Horizonte
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
City
Botucatu
ZIP/Postal Code
18618-686
Country
Brazil
Facility Name
Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro
City
Campinas
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Nucleo de Pesquisa do Hospital Pequeno Princípe
City
Curitiba
ZIP/Postal Code
80250-060
Country
Brazil
Facility Name
Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
City
Fortaleza
ZIP/Postal Code
60840-285
Country
Brazil
Facility Name
Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN
City
Natal
ZIP/Postal Code
59025-050
Country
Brazil
Facility Name
Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
City
Passo Fundo
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-074
Country
Brazil
Facility Name
Associacao Hospitalar Moinhos de Vento
City
Porto Alegre
ZIP/Postal Code
90035-901
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Fundacao Jose Luiz Egydio Setubal
City
Sao Paulo
ZIP/Postal Code
01227-200
Country
Brazil
Facility Name
CMPC - Consultoria Médica e Pesquisa Clínica
City
Sorocaba
ZIP/Postal Code
18040-425
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Votuporanga
City
Votuporanga
ZIP/Postal Code
15500-003
Country
Brazil
Facility Name
UMHAT 'Dr. Georgi Stranski', EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT 'Sveti Georgi'-Plovdiv
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
UMHAT 'Kanev' EAD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Medical Center-1-Sevlievo EOOD
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
Acibadem City Clinic Tokuda Hospital
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
UMHAT 'Aleksandrovska' EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
SHATCD 'Prof. Ivan Mitev' EAD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Antoine Beclere
City
CLAMART Cedex
ZIP/Postal Code
92141
Country
France
Facility Name
CHU de Montpellier - Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
CHU de Nantes hôtel-Dieu
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Hopitaux pediatriques CHU Lenval
City
Nice
ZIP/Postal Code
6200
Country
France
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Kinderarztpraxis Bramsche
City
Bramsche
ZIP/Postal Code
49565
Country
Germany
Facility Name
Hürthpark Kinder & Jugendärzte
City
Hürth
ZIP/Postal Code
50354
Country
Germany
Facility Name
Praxiszentrum Triftplatz
City
Schönau am Königssee
ZIP/Postal Code
83471
Country
Germany
Facility Name
Kinderärztliche Gemeinschaftspraxis
City
Wolfsburg
ZIP/Postal Code
38448
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Semmelweis Egyetem, II. sz. Gyermekgyógyászati Klinika
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Facility Name
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ,Infektológiai Klinika
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Futurenest Klinikai Kutato Kft.
City
Miskolc
ZIP/Postal Code
3528
Country
Hungary
Facility Name
Kanizsai Dorottya Kórház
City
Nagykanizsa
ZIP/Postal Code
8800
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Csolnoky Ferenc Korhaz
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
A.O.U Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40100
Country
Italy
Facility Name
ASST Fatebenefratelli Sacco / Ospedale dei Bambini V. Buzzi
City
Milano
ZIP/Postal Code
20154
Country
Italy
Facility Name
Dipartimento di Pediatria dell'Ospedale Luigi Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Department of Pediatrics University of Pavia, Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale degli Infermi
City
Ponderano
ZIP/Postal Code
13875
Country
Italy
Facility Name
Hosaka Kodomo Clinic
City
Bunkyo-Ku
ZIP/Postal Code
112-0001
Country
Japan
Facility Name
Kobayashi Pediatric Clinic
City
Fujieda
ZIP/Postal Code
426-0067
Country
Japan
Facility Name
Fukui-ken Saiseikai Hospital
City
Fukui City
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
National Hospital Organization Fukuyama Medical Center
City
Fukuyama
ZIP/Postal Code
720-8520
Country
Japan
Facility Name
Fukuyama City Hospital
City
Fukuyama
ZIP/Postal Code
721-8511
Country
Japan
Facility Name
Tanabe Pediatrics Clinic
City
Hatsukaichi
ZIP/Postal Code
738-0027
Country
Japan
Facility Name
Kagoshima Children's Hospital
City
Hioki
ZIP/Postal Code
899-2503
Country
Japan
Facility Name
National Hospital Organization Hirosaki General Medical Center
City
Hirosaki
ZIP/Postal Code
036-8545
Country
Japan
Facility Name
Shirao Clinic of Pediatrics and Pediatric Allergy
City
Hiroshima
ZIP/Postal Code
734-0023
Country
Japan
Facility Name
National Hospital Organization Kanazawa Medical Center
City
Kanazawa
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Daido Hospital
City
Nagoya
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Kojunkai Daido Clinic
City
Nagoya
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
National Hospital Organization Beppu Medical Center
City
Oita
ZIP/Postal Code
874-0011
Country
Japan
Facility Name
Momotaro Clinic
City
Okayama City
ZIP/Postal Code
701-0205
Country
Japan
Facility Name
National Hospital Organization Saitama National Hospital
City
Saitama
ZIP/Postal Code
351-0102
Country
Japan
Facility Name
KKR Sapporo Medical Center
City
Sapporo
ZIP/Postal Code
062-0931
Country
Japan
Facility Name
Tsuda Pediatrics Clinic
City
Setagaya-ku
ZIP/Postal Code
154-0017
Country
Japan
Facility Name
Okawa Children & Family Clinic
City
Tokyo
ZIP/Postal Code
146-0095
Country
Japan
Facility Name
INAMI Pediatric clinic
City
Tokyo
ZIP/Postal Code
154-0002
Country
Japan
Facility Name
The Catholic University of Korea, Incheon St. Mary's Hospital
City
Incheon
ZIP/Postal Code
403-720
Country
Korea, Republic of
Facility Name
Nowon Eulji Medical Center, Eulji University
City
Seoul
ZIP/Postal Code
01830
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
ZIP/Postal Code
1757
Country
Korea, Republic of
Facility Name
Hospital Selayang
City
Batu Caves
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Hospital Miri
City
Miri
ZIP/Postal Code
98000
Country
Malaysia
Facility Name
Hospital Tuanku Fauziah
City
Pusat Bandar Kangar
ZIP/Postal Code
01000
Country
Malaysia
Facility Name
Hospital Sibu
City
Sibu
ZIP/Postal Code
96000
Country
Malaysia
Facility Name
RM Pharma Specialists
City
Benito Juarez
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Hospital Infantil de Mexico Federico Gomez
City
Ciudad De Mexico
ZIP/Postal Code
6720
Country
Mexico
Facility Name
Instituto Nacional de Pediatría
City
Coyoacan
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Hospital Civil de Guadalajara
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Osrodek Badan Klinicznych In-Vivo Sp. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-090
Country
Poland
Facility Name
Zespol Opieki Zdrowotnej w Debicy, Oddzial Dzieciecy
City
Debica
ZIP/Postal Code
39-200
Country
Poland
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddzial Pediatrii i Neurologii Dzieciecej
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
NZOZ Salmed
City
Leczna
ZIP/Postal Code
21-010
Country
Poland
Facility Name
Instytut Gruzlicy i Chorob Pluc Oddzial Terenowy im. Rudnikow w Rabce-Zdroj, Oddzial Pulmonologii
City
Rabka-Zdroj
ZIP/Postal Code
34-700
Country
Poland
Facility Name
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o.o.
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Szpital im. Swietej Jadwigi Slaskiej, Oddział Pediatryczny z Pododdziałem Niemowlęcym
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland
Facility Name
Infectious Clinical Hospital #1 Of The Moscow City Health Department
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
OOO MDP-Medical Group
City
Odintsovo
ZIP/Postal Code
143005
Country
Russian Federation
Facility Name
City Children Clinical Outpatient Clinic #5
City
Perm
ZIP/Postal Code
614066
Country
Russian Federation
Facility Name
OOO 'Medical Technologies'
City
St. Petersburg
ZIP/Postal Code
191025
Country
Russian Federation
Facility Name
Children Outpatient Clinic 45 Of Nevskiy Region
City
St. Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
OOO 'Arsvite North-West'
City
St. Petersburg
ZIP/Postal Code
194223
Country
Russian Federation
Facility Name
LLC Pitercliniсa
City
St. Petersburg
ZIP/Postal Code
196158
Country
Russian Federation
Facility Name
LLC Kurator
City
St. Petersburg
ZIP/Postal Code
196240
Country
Russian Federation
Facility Name
Siberian State Medical University
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Bashkir State Medical University
City
Ufa
ZIP/Postal Code
450083
Country
Russian Federation
Facility Name
Yaroslavl State Medical University Based On Children Polyclinics #5
City
Yaroslavl
ZIP/Postal Code
150000
Country
Russian Federation
Facility Name
Tygrberg Hospital
City
Bellville
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Josha Research
City
Bloemfontein
ZIP/Postal Code
9300
Country
South Africa
Facility Name
VX Pharma
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Two Military Hospital
City
Wynberg
ZIP/Postal Code
7824
Country
South Africa
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hosp. Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hosp. Univ. de Burgos
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hosp. Univ. de Getafe
City
Getafe
ZIP/Postal Code
28020
Country
Spain
Facility Name
Hosp. Univ. Fund. Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hosp. Univ. Pta. de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28221
Country
Spain
Facility Name
Hosp. Regional Univ. de Malaga
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Hosp. Puerta Del Sur
City
Mostoles
ZIP/Postal Code
28938
Country
Spain
Facility Name
Hosp. Quiron Madrid Pozuelo
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hosp. Clinico Univ. de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Barn- Och Ungdomsmedicin
City
Malmö
ZIP/Postal Code
20502
Country
Sweden
Facility Name
Sachsska barn-och ungdomssjukhuset
City
Stockholm
ZIP/Postal Code
11861
Country
Sweden
Facility Name
Astrid Lindgrens barnsjukhus Solna
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Hsinchu MacKay Memorial Hospital
City
Hsinchu
ZIP/Postal Code
30071
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Municipal Wanfang Hospital
City
Taipei
ZIP/Postal Code
11696
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital- Linkou
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Queen Sirikit National Institute of Child Health
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Tropical Medicine Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Research Institute for Health Sciences
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Cukurova University Medical Faculty Balcali Hospital
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Ankara University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Gazi University Medical Faculty
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Facility Name
Ankara Bilkent Sehir Hastanesi
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital
City
Sarıyer
ZIP/Postal Code
34453
Country
Turkey
Facility Name
Karadeniz Teknik University Medical Faculty
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Royal Devon & Exeter Hospital
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Whipps Cross University Hospital
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
The Adam Practice
City
Poole
ZIP/Postal Code
BH16 5PW
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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