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A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)

Jennifer Peter Kent Richmond RN MBBS MRCP(UK) FRACP Clinical Research Manager Head, Vaccine Trials Group Jennifer.Kent@thekids.org.au Clinical

A phase 3, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety and tolerability of V114 in healthy infants (PNEULINK)

Jennifer Peter Kent Richmond RN MBBS MRCP(UK) FRACP Clinical Research Manager Head, Vaccine Trials Group Jennifer.Kent@thekids.org.au Clinical

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

A Phase III, randomized, controlled, observer-blind study to demonstrate effectiveness, immunogenicity and safety of GSK's meningococcal Group B and combined ABCWY vaccines when administered to healthy adolescents and young adults (Quintet)

Jennifer Peter Kent Richmond RN MBBS MRCP(UK) FRACP Clinical Research Manager Head, Vaccine Trials Group Jennifer.Kent@thekids.org.au Clinical

A randomized, controlled, observer-blind, phase 1/2a study to evaluate the safety, reactogenicity, and immunogenicity of Ad26.RSV.preF in RSV-seronegative toddlers 12 to 24 months of age

Jennifer Peter Kent Richmond RN MBBS MRCP(UK) FRACP Clinical Research Manager Head, Vaccine Trials Group Jennifer.Kent@thekids.org.au Clinical

AusVaxSafety

Christopher Peter Peter Tom Blyth Jacoby Richmond Snelling MBBS (Hons) DCH FRACP FRCPA PhD BA (Hons) MSc MBBS MRCP(UK) FRACP BMBS DTMH GDipClinEpid

Functional skills in MECP2 duplication syndrome: developmental dynamics and regression

MECP2 duplication syndrome (MDS) is an ultrarare, X-linked neurodevelopmental disorder that is poorly understood in terms of its natural history and phenotypic variability. There is limited information on how individuals with MDS acquire, retain or lose fundamental functional skills (gross motor, purposeful hand function and communication) - that of which this study aimed to better characterise in the largest case series to date.

Understanding motivation and experience in participating in a paediatric SARS-CoV-2 serosurvey, in Australia

Serosurveys are considered as a valuable tool in estimating population immunity and infection rates but recruitment of children to provide paediatric estimates can be challenging. A novel approach of sampling children undergoing anaesthesia was utilised for a SARS-CoV-2 serosurvey in Australian children and we explore the reasons for participation, feedback on the approach and importance of research into Coronavirus Diseases 2019 (COVID-19).

Ontogeny of plasma cytokine and chemokine concentrations across the first four months of human life in a Papua new Guinean cohort

Dynamic molecular changes in early life follow a robust ontogeny as the infant immune system adapts to the demands of its new environment. Studies of plasma immunomodulatory cytokines and chemokines have previously demonstrated ontogenetic patterns of immune development across the first week of life. However, how plasma cytokine and chemokines concentrations evolve over the first 4 months of life remains unknown.

Evaluating the impact of the ‘Blow, Breathe, Cough’ health promotion intervention in resolving otitis media with effusion in children: An adaptive randomized-controlled trial protocol

Otitis media with effusion (OME) affects hearing, speech development, and quality of life (QoL) in children. The 'Blow, Breathe, Cough' (BBC) intervention promotes nasal, respiratory, and middle ear clearance through nose blowing, deep breathing, coughing, and hand hygiene. It shows promise in resolving OME but lacks randomized-controlled trial (RCT) evaluation. This paper presents a RCT protocol evaluating BBC's effect on OME resolution, hearing, speech, and QoL in children aged two to seven years.