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Research
Cardiac monitoring safety assessment framework for early phase group a streptococcal vaccine trialsThis paper presents a comprehensive cardiac safety framework for early clinical development of Streptococcus pyogenes (Group A Streptococcus) vaccines, endorsed by the Strep A Vaccine Global Consortium and the Australian Strep A Vaccine Initiative. Given historical concerns about vaccine-associated acute rheumatic fever, we have established standardized echocardiography protocols integrated with clinical assessment for monitoring cardiac safety in early-phase vaccine trials.
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Acellular Pertussis Vaccine Given in the Week After Birth Does Not Impair Antibody Responses to Later Childhood DosesA birth acellular pertussis vaccine may be a valuable alternative for immunity against infant pertussis when a pregnancy pertussis vaccine has not been administered. We assessed whether a birth dose may impair immunoglobulin G (IgG) responses to childhood pertussis boosters.
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Postsepsis Care Needs in Children and Families: Single-Center, Codesign Qualitative Research from Western AustraliaSepsis, for children and their parents, is a life-altering illness with far-reaching psychosocial and physical impacts. We aimed to explore the needs of such patients and their parents after hospital admission for sepsis to inform the development of a Western Australian postsepsis care service.
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Comorbidities and confusion: addressing COVID-19 vaccine access and information challengesEarly in the coronavirus disease 2019 (COVID-19) pandemic, evidence emerged that individuals with chronic and immunocompromising conditions faced increased risk of severe infection, including death. The Australian Government and public health authorities prioritised these citizens' access to vaccines, including them in phase 1b of the rollout from 22 March 2021.
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Impact of early childhood infection on child development and school performance: a population-based studyChildhood infection might be associated with adverse child development and neurocognitive outcomes, but the results have been inconsistent.
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Edaravone for the Treatment of Motor Neurone Disease: A Critical Review of Approved and Alternative Formulations against a Proposed Quality Target Product ProfileEdaravone is one of two main drugs for treating motor neurone disease (MND). This review proposes a specific quality target product profile (QTPP) for edaravone following an appraisal of the issues accounting for the poor clinical uptake of the approved IV and oral liquid edaravone formulations. This is followed by a review of the alternative oral formulations of edaravone described in the published patent and journal literature against the QTPP.
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Antimicrobial Resistance in Enterobacterales, Acinetobacter spp. and Pseudomonas aeruginosa Isolates From Bloodstream Infections in Australian Children, 2013–2021Gram-negative bloodstream infections are associated with significant morbidity and mortality in children. Increasing antimicrobial resistance (AMR) is reported globally, yet efforts to track pediatric AMR at a national level over time are lacking.
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4CMenB Breadth of Immune Response, Immunogenicity, and Safety: Results from a Phase 3 Randomized, Controlled, Observer Blind Study in Adolescents and Young AdultsMeningococcal serogroup B (MenB) strains are highly diverse. Breadth of immune response for the MenB vaccine, 4CMenB, administered at 0-2, 0-6, or 0-2-6 months, was demonstrated by endogenous complement-human serum bactericidal antibody (enc-hSBA) assay against an epidemiologically relevant panel of 110 MenB strains.
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Does adjunctive clindamycin have a role in Staphylococcus aureus bacteremia? A protocol for the adjunctive treatment domain of the S. aureus Network Adaptive Platform (SNAP) randomized controlled trialThe use of adjunctive antibiotics directed against exotoxin production in Staphylococcus aureus bacteremia (SAB) is widespread, and is recommended in many guidelines, but there is limited evidence underpinning this.
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Pneumococcal carriage, serotype distribution, and antimicrobial susceptibility in Papua New Guinean children vaccinated with PCV10 or PCV13 in a head-to-head trialChildren in Papua New Guinea (PNG) are at high risk of pneumococcal infections. We investigated pneumococcal carriage rates, serotype distribution, and antimicrobial susceptibility in PNG children after vaccination with 10-valent or 13-valent pneumococcal conjugate vaccines (PCV10; PCV13).