NCT04068792 - A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 10, 2019

Primary Completion Date

May 15, 2021

Study Completion Date

May 15, 2021

Conditions

Respiratory Syncytial Viruses

Interventions

OTHER

RSV Mobile Application

Participants will not receive any intervention in observational phase of this study. Participant's respiratory symptoms will be captured by RSV mobile application installed in participant's caregiver/parent mobile phone.

DRUG

Placebo

Participants in each Age Group (1,2,3) will receive matching placebo (volume placebo to match the calculated volume of the JNJ-53718678 dose) orally twice daily for 7 days.

DRUG

JNJ-53718678 2.5 mg/kg

JNJ-53718678 will be administered to Age Group 1 twice daily for 7 days.

DRUG

JNJ-53718678 3 mg/kg

JNJ-53718678 will be administered to Age Group 2 twice daily for 7 days.

DRUG

JNJ-53718678 4.5 mg/kg

JNJ-53718678 will be administered to Age Group 3 twice daily for 7 days.

Trial Locations (10)

333

Chang Gung Memorial Hospital- Linkou, Taoyuan District

2650

UZ Antwerpen, Edegem

10002

National Taiwan University Hospital, Taipei

10449

Department of Pediatrics, MacKay Memorial Hospital, Taipei

30071

Hsinchu MacKay Memorial Hospital, Hsinchu

Unknown

Instituto de Maternidad y Ginecología Nuestra Senora de las Mercedes, San Miguel de Tucumán

000000

Cevaxin 24 de diciembre, Panama City

Cevaxin Avenida Mexico, Panama City

Cevaxin La Chorrera, Republica de Panama

SW17 0QT

St George's University Hospital NHS Foundation Trust, London

All Listed Sponsors

lead

Janssen Research & Development, LLC

INDUSTRY