Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection
Public ClinicalTrials.gov record NCT03656510. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 \[Cohort 2\]).
Study identification
- NCT ID
- NCT03656510
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 246 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 28 Days to 3 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 28, 2018
- Primary completion
- Apr 17, 2022
- Completion
- Apr 17, 2022
- Last update posted
- Feb 3, 2025
2018 – 2022
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Madera Family Medical Group | Madera | California | 93637 | — |
| FOMAT Medical Research | Ventura | California | 93003 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Elite Clinical Trials | Blackfoot | Idaho | 83221 | — |
| Saltzer Medical Group | Nampa | Idaho | 83686 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Craig A. Spiegel, MD | Bridgeton | Missouri | 63044 | — |
| SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH) | Syracuse | New York | 13210 | — |
| Santiago Reyes, MD | Oklahoma City | Oklahoma | 73112 | — |
| Coastal Pediatric Research | Summerville | South Carolina | 29486 | — |
| Sanford Health | Sioux Falls | South Dakota | 57105 | — |
| Children's Hospital of Richmond at VCU | Richmond | Virginia | 23298 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 155 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03656510, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 3, 2025 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03656510 live on ClinicalTrials.gov.