Respiratory Syncytial Viruses Clinical Trial
Official title:
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
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02561871 -
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers
|
Phase 1 | |
| Completed |
NCT04086472 -
Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005)
|
Phase 2 | |
| Terminated |
NCT02935673 -
Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus
|
Phase 2 | |
| Completed |
NCT03303625 -
A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age
|
Phase 1/Phase 2 | |
| Terminated |
NCT03333317 -
A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus
|
Phase 2 | |
| Recruiting |
NCT06077968 -
A Study to Learn About ABRYSVO Vaccine in Older Adults to Prevent Severe Respiratory Syncytial Virus (RSV) Infection.
|
||
| Active, not recruiting |
NCT05966090 -
A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults
|
Phase 3 | |
| Completed |
NCT04908683 -
A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older
|
Phase 3 | |
| Completed |
NCT03026348 -
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
|
Phase 2 | |
| Completed |
NCT00585481 -
Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children
|
N/A | |
| Completed |
NCT05712460 -
A Study to Assess the Safety, Effects and Palatability of Sisunatovir in Healthy Adult Participants
|
Phase 1 | |
| Completed |
NCT01249625 -
The Respiratory Protection Effectiveness Clinical Trial
|
N/A | |
| Completed |
NCT00263900 -
TGV:Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit
|
N/A | |
| Terminated |
NCT03982199 -
A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
|
Phase 2 |