An epidemiological study to estimate the burden of respiratory syncytial virus (RSV) infection in adults aged >- 60 years with acute respiratory infection (ARI), in Japan.
- Conditions
- Acute Respiratory Infection / RS Virus Infection
- Registration Number
- JPRN-jRCT1030210195
- Lead Sponsor
- Katsumata Masayuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 3000
A male or female aged >- 60 years at onset of ARI.
- Participants diagnosed with at least 2 ARI symptoms/signs meeting the ARI case definition, for at least 24 hours, and an onset date of first symptom/sign less than 10 days before the medical visit at an outpatient clinic/outpatient hospital.
- Participants who in the opinion of the investigator, can and will comply with the requirements of the study procedures (e.g. agree to provide nasal and throat swab samples, complete self-administered questionnaires, attend regular phone calls, etc.).
- Participants who are able to provide written informed consent.
- History of vaccination with an investigational RSV vaccine and administration of any RSV drugs or planned administration, anytime during the study period.
Note: Any RSV drug includes any investigational, preventative or curative drug targeting RSV specifically (including biological products such as vaccines).
- Participants with a known cognitive impairment (based on the medical judgement of the investigator).
- Re-enrolment if new ARI symptoms/signs are reported within 7 days from the resolution of the previous ARI or before study conclusion of the previous ARI episode.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method