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A Phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine given as a series of 2 infant doses and 1 toddler dose in healthy infants (NeXXstep)Jennifer Peter Kent Richmond RN MBBS MRCP(UK) FRACP Clinical Research Manager Head, Vaccine Trials Group Jennifer.Kent@thekids.org.au Clinical
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OPTIMUM: OPTimising IMmunisation Using Mixed schedulesPat Peter Susan Tom Jennifer Holt Richmond Prescott Snelling Kent PhD, DSc, FRCPath, FRCPI, FAA MBBS MRCP(UK) FRACP MBBS BMedSci PhD FRACP BMBS DTMH
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Estimating the impact of Western Australia's first respiratory syncytial virus immunisation program for all infants: A mathematical modelling studyThe Australian Therapeutic Goods Administration approved the use of nirsevimab, a long-acting monoclonal antibody for the prevention of Respiratory Syncytial Virus (RSV), in November 2023. Western Australia (WA) implemented a combination of nirsevimab administration strategies designed to protect all infants starting in April 2024, before the epidemic season. We developed a dynamic transmission model to predict the impact of WA's RSV immunisation program on infant hospitalisations.
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Haemophilus influenzae remains the predominant otitis media pathogen in Australian children undergoing ventilation tube insertion in the PCV13 eraUnderstanding patterns of bacterial carriage and otitis media (OM) microbiology is crucial for assessing vaccine impact and informing policy. The microbiology of OM can vary with geography, time, and interventions like pneumococcal conjugate vaccines (PCVs). We evaluated the microbiology of nasopharyngeal and middle ear effusions in children living in Western Australia, 11 years following the introduction of PCV13.
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Nirsevimab binding-site conservation in respiratory syncytial virus fusion glycoprotein worldwide between 1956 and 2021: an analysis of observational study sequencing dataNirsevimab is an extended half-life monoclonal antibody to the respiratory syncytial virus (RSV) fusion protein that has been developed to protect infants for an entire RSV season. Previous studies have shown that the nirsevimab binding site is highly conserved. However, investigations of the geotemporal evolution of potential escape variants in recent (ie, 2015–2021) RSV seasons have been minimal.
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Determining the true incidence of seasonal respiratory syncytial virus-confirmed hospitalizations in preterm and term infants in Western AustraliaRespiratory syncytial virus contributes to significant global infant morbidity and mortality. We applied a previously developed statistical prediction model incorporating pre-pandemic RSV testing data and hospital admission data to estimate infant RSV-hospitalizations by birth month and prematurity, focused on infants aged <1 year.
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A Phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V114 compared with PCV13 in healthy infants (PNEU-PED-EU-1)V114 (15-valent pneumococcal conjugate vaccine [PCV]) contains all serotypes in 13-valent PCV (PCV13) and additional serotypes 22F and 33F. This study evaluated safety and immunogenicity of V114 compared with PCV13 in healthy infants, and concomitant administration with DTPa-HBV-IPV/Hib and rotavirus RV1 vaccines.
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Ear Portal: An urban-based ear, nose, and throat, and audiology referral telehealth portal to improve access to specialist ear-health services for childrenShortage of ear, nose, and throat specialists in public hospitals can result in delays in the detection and management of otitis media. This study introduced a new hospital-based telehealth service, named the Ear Portal, and investigated its role in improving access to specialist care.
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Respiratory syncytial virus prevention within reach: the vaccine and monoclonal antibody landscapeRespiratory syncytial virus is the second most common cause of infant mortality and a major cause of morbidity and mortality in older adults (aged >60 years). Efforts to develop a respiratory syncytial virus vaccine or immunoprophylaxis remain highly active.
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Postvaccination Febrile Seizure Severity and OutcomeVaccine-proximate febrile seizures accounted for a small proportion of all febrile seizures hospital presentations