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.
Trial overview
Number of participants with reverse transcription polymerase chain reaction (RT-PCR) confirmed RSV-ARI in combined nasal and throat swab samples
Timeframe: At Visit 1 (Day 1)
Duration of ARI in participants with RT-PCR-confirmed RSV infection
Timeframe: During the 28 days after Visit 1 (until Day 29) if ARI resolves within 4 weeks or for 56 days after Visit 1 (until Day 57) if ARI resolves after 4 weeks
Number of participants with RT-PCR-confirmed RSV infection reporting certain symptoms/signs of ARI
Timeframe: During the 28 days after Visit 1 (until Day 29) if ARI resolves within 4 weeks or for 56 days after Visit 1 (until Day 57) if ARI resolves after 4 weeks
Number of participants with RT-PCR confirmed RSV-LRTD in combined nasal and throat swab samples
Timeframe: At Visit 1 (Day 1)
Number of participants with RT-PCR confirmed RSV-ARI experiencing complications, hospitalizations and deaths
Timeframe: During the 28 days after Visit 1 (until Day 29) if ARI resolves within 4 weeks or for 56 days after Visit 1 (until Day 57) if ARI resolves after 4 weeks
Number of participants with RT-PCR confirmed RSV-ARI having other viral pathogens in combined nasal and throat swabs samples
Timeframe: At Visit 1 (Day 1)
Distribution of HRQoL Influenza Patient-reported Outcome (Flu-PRO) questionnaires
Timeframe: At Days 1, 8 and 15
Distribution of HRQoL EuroQol- 5 Dimension (EQ-5D) questionnaires
Timeframe: At Days 1, 8, 15 and 29 (also on Day 57 in case the ARI is not resolved by Day 29)
Number and type of healthcare resources used and working days lost by participants presenting with ARI and associated caregivers
Timeframe: During the 28 days after Visit 1 (until Day 29) if ARI resolves within 4 weeks or for 56 days after Visit 1 (until Day 57) if ARI resolves after 4 weeks
Number of participants with ARI having RT-PCR confirmed respiratory viral pathogens other than RSV in combined nasal and throat swab samples
Timeframe: At Visit 1 (Day 1)
Duration of ARI in participants infected with respiratory viruses other than RSV
Timeframe: During the 28 days after Visit 1 (until Day 29) if ARI resolves within 4 weeks or for 56 days after Visit 1 (until Day 57) if ARI resolves after 4 weeks
Number of participants infected with respiratory viruses other than RSV reporting certain symptoms/signs of ARI
Timeframe: During the 28 days after Visit 1 (until Day 29) if ARI resolves within 4 weeks or for 56 days after Visit 1 (until Day 57) if ARI resolves after 4 weeks
Number of participants infected with respiratory viruses other than RSV reporting certain symptoms/signs of ARI
Timeframe: During the 28 days after Visit 1 (until Day 29) if ARI resolves within 4 weeks or for 56 days after Visit 1 (until Day 57) if ARI resolves after 4 weeks.
Number of participants infected with respiratory viruses other than RSV experiencing complications, hospitalizations and deaths
Timeframe: During the 28 days after Visit 1 (until Day 29) if ARI resolves within 4 weeks or for 56 days after Visit 1 (until Day 57) if ARI resolves after 4 weeks
Participation criteria
- A male or female aged ≥ 60 years at onset of ARI.
- Participants who were diagnosed, at the time of enrolment, 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.
- History of vaccination with an investigational RSV vaccine and administration of any RSV drugs or planned administration, anytime during the study period.
- Participants with a known cognitive impairment.
- Participants who were diagnosed, at the time of enrolment, 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. *Note: The implementation of the change from 7-day window to 10-day window will take place starting from season 2, following the protocol amendment 2.
- Participants who in the opinion of the investigator, can and will comply with the requirements of the study procedures.
- Participants who are able to provide written informed consent.
A male or female aged ≥ 60 years at onset of ARI.
- Participants with a known cognitive impairment.
- 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.
History of vaccination with an investigational RSV vaccine and administration of any RSV drugs or planned administration, anytime during the study period.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.