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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

NCT04068792 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-02-04

Study results available
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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.

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-10
Primary Completion
2021-05-15
Completion
2021-05-15
FDA Drug
Yes

Countries

  • Argentina
  • Belgium
  • Panama
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04068792 on ClinicalTrials.gov