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A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease

A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Interventional Stage) to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 in Infants With Acute Respiratory Tract Infection Due to RSV

NCT04068792•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this two-part designed study is to assess in the setting of a planned early interception of pediatric RSV disease, early viral and disease kinetics (observational stage) and the antiviral effects of an Respiratory Syncytial Virus (RSV) fusion inhibitor, JNJ-53718678 (interventional stage). In the observational stage the infant is closely monitored for early symptoms by the parent(s)/caregiver(s) and thus may be brought in for diagnosis earlier than in the typical setting.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Part 1: Observational Stage
•The infant is less than or equal to (\<=) 4 months of age at enrollment and asymptomatic for acute respiratory illness (ARI)-like symptoms requiring medical intervention at the time of consent to participate in the study
•At least 1 parent/caregiver must be able to use the respiratory syncytial virus (RSV) mobile application (App) at home via his/her own Android/iOS electronic device (compatible with RSV mobile App)
•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
•Part 2: Interventional Stage
•The infant is 28 days and if prematurely born infant (that is \[i.e.\], less than \[\<\] 37 weeks and 0 days of gestation at birth) is at least 3 months postnatal age
•The participant has been diagnosed with RSV infection using a rapid molecular-based diagnostic assay
•The participant weighs more than 2.4 kilogram (kg)
•The participant has an acute respiratory illness as evaluated by the investigator
•Except for the RSV-related illness, the participant must be medically stable in case of allowed co-morbid conditions
+1 more criteria

Exclusion Criteria

•Part 1: Observational Stage
•The participant has any physical abnormality which limits the ability to collect regular nasal specimens
•The participant is receiving chronic home oxygen therapy at enrollment (applicable to both parts)
•Part 2: Interventional Stage
•The participant is \<3 months postnatal age at screening and was born prematurely (i.e., \<37 weeks and 0 days of gestation) or if the participant weights \<2.4 kg
•The participant has a QT interval with Fridericia's correction (QTcF) greater than (\>) 450 milliseconds per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate Electrocardiogram (ECG) recording during screening
•The participant is considered by the investigator to be immunocompromised, whether due to underlying medical condition or medical therapy
•The participant has had any of: a) Confirmed SARS-CoV-2 infection (test positive) during the four weeks prior to randomization, or b) Close contact with a person with Coronavirus Disease 2019 (COVID-19) (test confirmed or suspected SARS-CoV-2 infection) within 14 days prior to randomization

Locations (10)

Instituto de Maternidad y Ginecología Nuestra Senora de las Mercedes

San Miguel de Tucumán, Argentina

UZ Antwerpen

Edegem, Belgium

Cevaxin 24 de diciembre

Panama City, Panama

Cevaxin Avenida Mexico

Panama City, Panama

Cevaxin La Chorrera

Republica de Panama, Panama

Hsinchu MacKay Memorial Hospital

Hsinchu, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Department of Pediatrics, MacKay Memorial Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital- Linkou

Taoyuan District, Taiwan

St George's University Hospital NHS Foundation Trust

London, United Kingdom

Key Dates

Start Date

October 10, 2019

Primary Completion Date

May 15, 2021

Completion Date

May 15, 2021

Last Updated

February 4, 2025

Enrollment

ACTUAL participants

Conditions

Respiratory Syncytial Viruses

Interventions

RSV Mobile Application

OTHER

Placebo

DRUG

JNJ-53718678 2.5 mg/kg

DRUG

JNJ-53718678 3 mg/kg

DRUG

JNJ-53718678 4.5 mg/kg

DRUG

A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults

NCT05966090

Respiratory Syncytial VirusesRespiratory Syncytial Virus Infections

View study

COMPLETEDPHASE2

Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults

NCT03026348

Respiratory Syncytial Viruses

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease

Inclusion Criteria

Exclusion Criteria

A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults

Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults

The Respiratory Protection Effectiveness Clinical Trial