J00-J99
Conditions
Interventions
Group 1: Study staff at each diagnostic site create a list on every working day of patients who are eligible for study inclusion. Cases are defined as hospitalized patients under 2 years of age (up to
Sponsors
Universitätsklinikum Würzburg, Kinderklinik und Poliklinik
Eligibility
Sex/Gender
All
Age
No minimum to 2 Years
Inclusion criteria
Inclusion criteria: Patients (cases and controls) – must be under 2 years of age (inclusion possible until the last day before the 2nd birthday) – must be admitted to the hospital due to an acute respiratory infection – the onset of respiratory symptoms must not be more than 7 days prior to hospitalization – must be hospitalized for at least one day (admission and discharge dates must differ) at one of the participating university hospitals – must have a positive or negative polymerase chain reaction (PCR) test result for RSV (sample collected during the hospital stay) – their parents or legal guardians must have sufficient German language skills to understand the informed consent and to complete the questionnaires – at least one parent or legal guardian must receive verbal and written information about the study and subsequently provide written informed consent – their parents or legal guardians must consent to verification of the child’s RSV immunization status by allowing access to the vaccination record (or, in the case of postnatal immunization in the participating hospital, access to the medical record). In case of maternal vaccination during pregnancy, they must consent to verification through inspection of the mother’s vaccination record or alternative verification of maternal vaccination(s) (e.g., confirmation by the physician’s practice that administered the vaccination).
Exclusion criteria
Exclusion criteria: Patients cannot be included in the study if: – they were transferred from another care facility or hospital – their parents or legal guardians are not capable of providing informed consent – their parents or legal guardians do not have sufficient German language skills
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study objective is to determine the effectiveness of the recommended immunization against RSV through the administration of nirsevimab (monoclonal pre-F antibodies against RSV, passive immunization) in children under 1 year of age with respect to protection against hospitalization due to RSV-associated respiratory infection (“RSV hospitalization”) during the periods from October 1 to April 30 in the RSV seasons 2025/26 and 2026/27. Primary study objective: Effectiveness of immunization with nirsevimab in children under 2 years of age for the endpoint RSV hospitalization in the first year of life (age under 12 months) and the second year of life (age 12–23 months), i.e., generally during the first and/or second RSV season after immunization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Studies using a test-negative design offer a cost-effective and comparatively low-effort study approach to rapidly generate effectiveness data in a real-world setting. A secondary aim of this study is to implement the methodology of the test-negative design for evaluating vaccine effectiveness within BayVak at Bavarian university children’s hospitals for relevant research questions. This will enable rapid effectiveness studies when new monoclonal antibodies and vaccines against RSV—but also against other important respiratory pathogens in children (including influenza A/B, human metapneumovirus, parainfluenza virus)—are approved in the coming years. Secondary study objective 1 – Effectiveness of immunization with nirsevimab (additional analyses) Additional secondary study objectives regarding the effectiveness of immunization against RSV through monoclonal antibodies (nirsevimab) include assessing effectiveness: – for the endpoint RSV hospitalization, depending on the time interval since immunization – for the endpoint RSV hospitalization across different disease severity categories: – hospitalization with upper respiratory tract infection (URTI) – hospitalization with lower respiratory tract infection (LRTI) – hospitalization requiring oxygen supplementation – hospitalization requiring high-flow respiratory support – hospitalization requiring mechanical ventilation – hospitalization requiring intensive care – for the endpoint hospitalization, stratified by relevant underlying conditions, including: – prematurity – chronic lung disease – congenital heart defects – syndromic disorders – neurological disorders – immunodeficiency Secondary study objective 2 – Assessment of acceptance of RSV immunization and maternal RSV vaccination – Assessment of acceptance of nirsevimab immunization in neonatal postnatal care at the participating university hospitals – Assessment of the proportion of study participants (RSV-negative cont | — |
Countries
Germany
Contacts
Public ContactJohannes Liese
Universitätsklinikum Würzburg, Kinderklinik und Poliklinik
Outcome results
None listed