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Open AccessAuthor Correction: Durability of neutralizing RSV antibodies following nirsevimab administration and elicitation of the natural immune response to RSV infection in infants
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Open AccessAuthor Correction: Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials
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Open AccessMolecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials
Nirsevimab is a monoclonal antibody that binds to the respiratory syncytial virus (RSV) fusion protein. During the Phase 2b (NCT02878330) and MELODY (NCT03979313) clinical trials, infants received one dose of ...
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Open AccessDurability of neutralizing RSV antibodies following nirsevimab administration and elicitation of the natural immune response to RSV infection in infants
Nirsevimab is an extended half-life monoclonal antibody specific for the prefusion conformation of the respiratory syncytial virus (RSV) F protein, which has been studied in preterm and full-term infants in th...
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Open AccessINFLATE: a protocol for a randomised controlled trial comparing nasal balloon autoinflation to no nasal balloon autoinflation for otitis media with effusion in Aboriginal and Torres Strait Islander children
Otitis media with effusion (OME) is common and occurs at disproportionately higher rates among Indigenous children. Left untreated, OME can negatively affect language, development, learning, and health and wel...
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Open AccessThe link between hearing impairment and child maltreatment among Aboriginal children in the Northern Territory of Australia: is there an opportunity for a public health approach in child protection?
International studies provide evidence of an association between child disabilities, including hearing impairment (HI), and child maltreatment. There are high prevalences of ear disease with associated HI, and...
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Open AccessHearing and justice: The link between hearing impairment in early childhood and youth offending in Aboriginal children living in remote communities of the Northern Territory, Australia
High prevalence of chronic middle ear disease has persisted in Australian Aboriginal children, and the related hearing impairment (HI) has been implicated in a range of social outcomes. This study investigated...
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Open AccessRandomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/AS02D malaria vaccine in infants living in a malaria-endemic region
The RTS,S/AS malaria candidate vaccine is being developed with the intent to be delivered, if approved, through the Expanded Programme on Immunization (EPI) of the World Health Organization. Safety, immunogeni...
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Open AccessStatistical methodology for the evaluation of vaccine efficacy in a phase III multi-centre trial of the RTS,S/AS01 malaria vaccine in African children
There has been much debate about the appropriate statistical methodology for the evaluation of malaria field studies and the challenges in interpreting data arising from these trials.
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Open AccessDesign of a phase III multicenter trial to evaluate the efficacy of the RTS,S/AS01 malaria vaccine in children across diverse transmission settings in Africa
GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative are working in partnership to develop a malaria vaccine to protect infants and children living in malaria endemic regions of sub-Saharan Afri...
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Open AccessAssessment of severe malaria in a multicenter, phase III, RTS, S/AS01 malaria candidate vaccine trial: case definition, standardization of data collection and patient care
An effective malaria vaccine, deployed in conjunction with other malaria interventions, is likely to substantially reduce the malaria burden. Efficacy against severe malaria will be a key driver for decisions ...
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Development of the RTS,S/AS Vaccine Candidate from Concept to Phase III
This review describes the developmental history of the RTS,S/AS vaccine. Selection of the circumsporozoite protein (CSP) as the target antigen was key to the successful development of the vaccine so far, from ...
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Open AccessEvaluation of two formulations of adjuvanted RTS, S malaria vaccine in children aged 3 to 5 years living in a malaria-endemic region of Mozambique: a Phase I/IIb randomized double-blind bridging trial
Previous trials of the RTS, S malaria candidate vaccine have shown that this vaccine is safe, tolerated and immunogenic. The development plan for this vaccine aims at administering it in the first year of life...