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Long-term follow-up after recurrent otitis media and ventilation tube insertion: Hearing outcomes and middle-ear health at six years of ageTo investigate the long-term impact of recurrent otitis media (rOM) and ventilation tube insertion (VTI) in early childhood on hearing outcomes and middle-ear health three to five years later, in a prospective pregnancy cohort study.
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A Phase 3, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate Safety, Tolerability, and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, in Allogeneic Hematopoietic Cell Transplant Recipients (PNEU-STEM)Individuals who receive allogeneic hematopoietic cell transplant (allo-HCT) are immunocompromised and at high risk of pneumococcal infections, especially in the months following transplant. This study evaluated the safety and immunogenicity of V114 (VAXNEUVANCE; Merck, Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA), a 15-valent pneumococcal conjugate vaccine (PCV), when given to allo-HCT recipients.
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Safety and immunogenicity of a primary series and booster dose of the meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) in healthy children aged 1–9 years: two phase 2 randomised, controlled, observer-blinded studiesThe meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) is licensed for use in children aged 10 years or older for protection against invasive serogroup B meningococcal disease. Because young children are at increased risk of invasive meningococcal disease, MenB-FHbp clinical data in this population are needed.
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Development of an International Database for a Rare Genetic Disorder: The MECP2 Duplication Database (MDBase)The natural history of MECP2 duplication syndrome (MDS), a rare X-linked neurodevelopmental disorder with an estimated birth prevalence of 1/150,000 live births, is poorly understood due to a lack of clinical data collected for research. Such information is critical to the understanding of disease progression, therapeutic endpoints and outcome measures for clinical trials, as well as the development of therapies and orphan products.
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Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathyThe reported frequency and types of adverse events following initial vaccination and revaccination with Bacille Calmette-Guérin (BCG) varies worldwide. Using active surveillance in a randomised controlled trial of BCG vaccination (the BRACE trial), we determined the incidence and risk factors for the development of BCG injection site abscess and regional lymphadenopathy.
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FeBRILe3: Risk-Stratification and Diagnosis of Serious Bacterial Infections in Febrile Infants Less Than 3 Months OldEvidence-based recommendations exist for early discharge (before 48 h) of young infants with fever without source (FWS) at low risk of serious bacterial infections (SBIs). However, concerns regarding the applicability of international data to local contexts may hinder implementation. We aimed to describe the local epidemiology of FWS and evaluate a newly implemented risk-stratification guideline to support practice change.
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High Nasopharyngeal Carriage of Non-Vaccine Serotypes in Western Australian Aboriginal People Following 10 Years of Pneumococcal Conjugate VaccinationInvasive pneumococcal disease (IPD) continues to occur at high rates among Australian Aboriginal people.
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A randomized, controlled, phase 1/2 trial of a neisseria meningitidis serogroup B bivalent rLP2086 vaccine in healthy children and adolescentsFactor H binding protein (also known as LP2086) is a conserved outer membrane neisserial lipoprotein that has emerged as a strong candidate protein antigen...
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Virus detection and its association with symptoms during influenza-like illness in a sample of healthy adultsOur findings indicate that a greater number of symptoms are displayed by individuals presenting with influenza confirmed ILI compared with other agents that...
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FluMum: A prospective cohort study of mother-infant pairs assessing the effectiveness of maternal influenza vaccination in revention of influenzaEvidence is emerging of benefit to the infant with respect to preventing influenza infection in the first 6 months of life. The FluMum study aims to...