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Protocol for establishing a core outcome set for evaluation in studies of pulmonary exacerbations in people with cystic fibrosisPulmonary exacerbations are associated with increased morbidity and mortality in people with cystic fibrosis (CF). There is no consensus about which outcomes should be evaluated in studies of pulmonary exacerbations or how these outcomes should be measured.
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Safety, tolerability, and effect of a single aural dose of Dornase alfa at the time of ventilation tube surgery for otitis media: A Phase 1b double randomized control trialOne third of children require repeat ventilation tube insertion (VTI) for otitis media. Disease recurrence is associated with persistent middle ear bacterial biofilms. With demonstration that Dornase alfa (a DNase) disrupts middle ear effusion biofilms ex vivo, we identified potential for this as an anti-biofilm therapy to prevent repeat VTI. First, safety and tolerability needed to be measured.
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FeBRILe3: Safety Evaluation of Febrile Infant Guidelines Through Prospective Bayesian MonitoringDespite evidence supporting earlier discharge of well-appearing febrile infants at low risk of serious bacterial infection (SBI), admissions for ≥48 hours remain common. Prospective safety monitoring may support broader guideline implementation.
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Using causal directed acyclic graphs (DAGs) to select patient-important outcomes in transplantation trials—interventions to treat polyomavirus infection as an exampleTom Snelling BMBS DTMH GDipClinEpid PhD FRACP Head, Infectious Disease Implementation Research 08 6319 1817 tom.snelling@thekids.org.au Head,
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Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care WorkersThe bacille Calmette-Guérin (BCG) vaccine has immunomodulatory "off-target" effects that have been hypothesized to protect against coronavirus disease 2019.
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Meningococcal Disease in the Post–COVID-19 Era: A Time to PrepareThe global invasive meningococcal disease (IMD) landscape changed considerably during the COVID-19 pandemic, as evidenced by decreased incidence rates due to COVID-19 mitigation measures, such as limited social contact, physical distancing, mask wearing, and hand washing. Vaccination rates were also lower during the pandemic relative to pre-pandemic levels.
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Mandating COVID-19 vaccinations for children: Attitudes of Western Australian parentsAustralian governments have used vaccine mandates to drive high uptake of routine childhood vaccines and adult Coronavirus Disease 2019 (COVID-19) and influenza vaccines. We sought to understand the attitudes of Western Australian parents regarding mandating COVID-19 vaccines for children, interviewing 44 parents of children aged up to 18 years between May and December 2021. Transcripts were analysed to ascertain parents' attitudes and sources of reasoning.
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Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) studySickle cell disease (SCD) is an inherited red blood cell disease that results in a multitude of medical complications, including an increased risk of invasive disease caused by encapsulated bacteria, such as Streptococcus pneumoniae. Pneumococcal vaccines have contributed to a significant reduction in pneumococcal disease (PD) in children and adults, including those with SCD. This phase 3 study evaluated the safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD.
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Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) studySickle cell disease (SCD) is an inherited red blood cell disease that results in a multitude of medical complications, including an increased risk of invasive disease caused by encapsulated bacteria, such as Streptococcus pneumoniae. Pneumococcal vaccines have contributed to a significant reduction in pneumococcal disease (PD) in children and adults, including those with SCD. This phase 3 study evaluated the safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV), in children with SCD.
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‘COVID Is Coming, and I’m Bloody Scared’: How Adults with Co-Morbidities’ Threat Perceptions of COVID-19 Shape Their Vaccination DecisionsAustralian Aboriginal and/or Torres Strait Islander children in rural/remote areas suffer high rates of persistent otitis media (OM) from early infancy. We aimed to determine the proportion of Aboriginal infants living in an urban area who have OM and investigate associated risk factors.