Purpose: We developed a hybrid safety surveillance approach for a large, pragmatic clinical trial of a high-dose quadrivalent influenza vaccine (QIV-HD), using both active and passive data collection methods. Here, we present the methods and results for the passive register-based surveillance of serious adverse events (SAEs), which replaced conventional SAE reporting during the trial.
Patients And Methods: The trial recruited over 33,000 older adults of whom 50% received the QIV-HD while the rest received a standard-dose vaccine (QIV-SD) as a control vaccine.
Unlabelled: The purpose of this study is to evaluate childhood bacterial meningitis (BM): incidence, clinical presentation, causative pathogens, diagnostics, and outcome (neurological sequelae, hearing loss, and death). A retrospective review of all children aged ≤ 16 years and 1 month diagnosed with BM at a tertiary children's centre in the period 2010-2020. The Glasgow Outcome Scale (GOS) was used to assess outcome, with a GOS score of 1-4 considered to be an unfavourable outcome.
View Article and Find Full Text PDFJ Pediatric Infect Dis Soc
November 2024
Background: While clinical risk factors for respiratory syncytial virus (RSV) bronchiolitis are well established, data on socioeconomic risk factors is lacking. We explored the association of parental education, income, and employment status on an infant's risk of hospitalization for RSV bronchiolitis.
Methods: This population-based retrospective case-control study covered all RSV-related hospital admissions of under 1-year-old children in Finland between 2004 and 2018.