Respiratory Syncytial Virus Infections
Conditions
Interventions
None listed
Sponsors
Janssen Pharmaceutical K.K. R&D Clinical Science div. Infectious disease & Vaccine Clinical Development Dept.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for selfcare and activities of daily living such as: a.) able to take care of all shopping needs independently; b.) able to travel independently; c.)able to operate telephone on their own (make or receive calls); d.) responsible for taking medication in correct dosages at correct time; e.) able to perform daily self-care such as bathing, changing clothes, using toilet and grooming - Participants may have one or more chronic medical diagnoses but should be clinically stable as assessed by absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator,render survival to completion of the protocol unlikely - Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment - Able to comply with study requirements; including access to transportation for study visits
Exclusion criteria
Exclusion criteria: -Participants received any experimental antiviral drugs or vaccines against respiratory syncytial virus (RSV) within 6 months prior to the signing Informed Consent Form (ICFs) - Participants who have acute respiratory disease (ARD) at the time of ICF and Week 0 (Baseline) at the discretion of the investigator - Participants with life expectancy less than 1 year - Participants unwilling to undergo nasopharyngeal swab procedures or with any physical abnormality which limits the ability to collect regular nasopharyngeal specimens - Participant who is not able to comply with study-related procedures,due to their mental status or severe clinical condition, based on clinical judgement of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Protocol Defined Respiratory Syncytial Virus (RSV)-Acute Respiratory Disease (ARD) Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) during study period (up to Week 52) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Number of Participants with Protocol Defined Respiratory Syncytial Virus(RSV)-Lower Respiratory Tract Disease (LRTD) Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) during study period (up to Week 52) -Incidence of Mortality Associated with RSV-ARD -Duration of RSV-ARD -Signs and Symptoms Associated with RSV-ARD -Number of Participants with Hospitalization, Outpatient Visit, and Emergency Room (ER) Visit due to RSV-ARD -Number of Participants with ARD caused by Different Types of Respiratory Pathogens Other Than RSV -Duration of ARD due to Different Types of Respiratory Pathogens Other Than RSV -Signs and Symptoms Associated with ARD Caused by Different Types of Respiratory Pathogens Other Than RSV -Number of Participants with Hospitalization, Outpatient Visit, and Emergency Room (ER) Visit due to ARD Caused by the Different Types of Respiratory Pathogens Other Than RSV -Percentage of Participants with RSV-LRTD by Age-Group, Underlying Comorbidities, Immunosuppression Status, Functional Status and Place of Residence | — |
Countries
Japan
Contacts
Public ContactMaho Yamada
Janssen Pharmaceutical K.K. R&D Clinical Science div. Infectious disease & Vaccine Clinical Development Dept.
Outcome results
None listed