B97.4
Conditions
Interventions
Group 1: Individuals presenting at the participating hospitals during the study period who are hospitalised, meet the modified-SARI case definition and meet the inclusion/exclusion criteria.
Modified
Sponsors
P95 Clinical & Epidemiology Services
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: • The patient is [=60] years old at the time of admission to the hospital. • The patient is eligible to receive vaccination against RSV for adults (not maternal vaccination) depending on the vaccination programme in the patient’s country of residence. • Informed consent is obtained from the patient or, when accepted by the Ethics Committee, from the patient’s LAR(s) prior to enrolment.
Exclusion criteria
Exclusion criteria: • The patient is unable or unwilling to provide the protocol-required respiratory specimen(s) for any reason. • Only for sites in the United Kingdom: (As defined by the UK Mental Capacity Act 2025), patients who are deemed mentally incapacitated to provide informed consent due to a condition other than SARI will be excluded from the study. For the UK Mental Capacity Act 2025, a person is considered unable to consent if, at the time of consent, they can’t make decisions for themselves because of mind or brain impairments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate RSV vaccine effectiveness against hospitalisation due to laboratory-confirmed RSV infection in older adult patients with modified SARI, eligible to receive the vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: As objective 1, but stratified by/subgroup analysis among: 2.1 RSV subtype A and B 2.2 Populations of special interest (e.g., age groups, sex, chronic medical condition risk groups, among the immunocompetent, among those with co-administered vaccines) 2.3 Time since vaccination 2.4 History and time since prior RSV infection within the last [12] months 2.5 Country and study site As objective 1 but using severity endpoints: 2.6 Modified-SARI severity level (footnote 1) Exploratory objectives: 3. Descriptive analysis of vaccinated and unvaccinated cases and controls: demographics, clinical, severity, length of hospital stay and laboratory characteristics. Footnote: (1) Severity levels are defined by hospital outcome (intensive care unit [ICU] admission; in-hospital death), respiratory support and/or length of hospital stay. As an additional indicator of severity at hospitalisation and throughout hospitalisation, progression risk is defined as proportion of in-hospital deaths and proportion of [ICU] admissions among all hospitalised SARI patients. | — |
Countries
France, Germany, Italy, Spain, United Kingdom
Contacts
Public ContactKaatje Bollaerts
P95 Clinical & Epidemiology Services
Outcome results
None listed