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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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“We've wanted to vaccinate against it and now we can”: views of respiratory syncytial virus disease and immunisation held by caregivers of Aboriginal children in Perth, Western AustraliaRespiratory syncytial virus (RSV) is a major cause of respiratory infection with a higher burden in Aboriginal and Torres Strait Islander infants and children. We conducted a pilot qualitative study identifying disease knowledge and willingness to immunise following the changing immunisation landscape for infant RSV in 2024.
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Breadth of immune response, immunogenicity, reactogenicity, and safety for a pentavalent meningococcal ABCWY vaccine in healthy adolescents and young adultsA multicomponent meningococcal serogroups ABCWY vaccine (MenABCWY) could provide broad protection against disease-causing meningococcal strains and simplify the immunisation schedule.
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Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 StudyDisease caused by Streptococcus pneumoniae is associated with considerable morbidity and mortality in children. Pneumococcal conjugate vaccines are well tolerated and effective at reducing pneumococcal disease caused by vaccine serotypes. VAXNEUVANCE (V114) is a 15-valent PCV containing 13 serotypes in Prevnar 13, plus serotypes 22F and 33F. This large phase 3 study evaluated safety and tolerability of V114 in infants.
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Pragmatic Adaptive Trial for Respiratory Infection in Children (PATRIC) Clinical Registry protocolAcute respiratory infections (ARI) are the most common cause of paediatric hospitalisation. There is an urgent need to address ongoing critical knowledge gaps in ARI management. The Pragmatic Adaptive Trial for Respiratory Infections in Children (PATRIC) Clinical Registry will evaluate current treatments and outcomes for ARI in a variety of paediatric patient groups.
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Impact of ventilation tube insertion on long-term language outcomes at 6 and 10 years of age: A prospective pregnancy cohort studyInvestigating the impact of early childhood ventilation tube insertion (VTI) on long-term language outcomes.
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Transiently increased IgE responses in infants and pre-schoolers receiving only (DTaP) vaccines compared to those initially receiving at least one dose of DTwP vaccineConfirm the generalised IgE-trophic activity of the DTaP vaccine in pre-schoolers and demonstrate similar (albeit transient) effects in infants
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Persistence of the immune responses and cross-neutralizing activity with Variants of Concern following two doses of adjuvanted SCB-2019 COVID-19 vaccineWe have previously reported the safety and immunogenicity four weeks after two doses of the Clover COVID-19 vaccine candidate, SCB-2019, a stabilized pre-fusion form of the SARS-CoV-2 S-protein (S-trimer). We now report persistence of antibodies up to 6 months after vaccination, and cross-neutralization titers against three Variants of Concern.
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Altered Behavior in Encephalitis: Insights From the Australian Childhood Encephalitis Study, 2013-2018Altered mental status is a major criterion for a diagnosis of encephalitis to be made with alteration in behavior, a key manifestation of altered mental status. We reviewed all evaluated cases identified by the Australian Childhood Encephalitis study between May 2013 and June 2018.