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6 result(s) for "Ramirez Schrempp, Daniela"
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Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age
In part 1 of a phase 2–3 trial, a 50-μg dose of mRNA-1273 vaccine was safe and immunogenic. In part 2, nearly 4000 6-to-11-year-olds received two doses of vaccine or placebo and were followed for a median of 82 days. The vaccine had mainly mild adverse effects and was immunogenic in 99%, similar to the results in 18-to-25-year-olds. Vaccine efficacy during a delta-variant period was 88%.
Safety and immunogenicity of a phase 1/2 randomized clinical trial of a quadrivalent, mRNA-based seasonal influenza vaccine (mRNA-1010) in healthy adults: interim analysis
Despite vaccine availability, influenza remains a substantial global public health concern. Here, we report interim findings on the primary and secondary objectives of the safety, reactogenicity, and humoral immunogenicity of a quadrivalent messenger RNA (mRNA) vaccine against seasonal influenza, mRNA-1010, from the first 2 parts of a 3-part, first-in-human, phase 1/2 clinical trial in healthy adults aged ≥18 years (NCT04956575). In the placebo-controlled Part 1, a single dose of mRNA-1010 (50 µg, 100 µg, or 200 µg) elicited hemagglutination inhibition (HAI) titers against vaccine-matched strains. In the active-comparator-controlled Part 2, mRNA-1010 (25 µg, 50 µg, or 100 µg) elicited higher HAI titers than a standard dose, inactivated seasonal influenza vaccine for influenza A strains and comparable HAI titers for influenza B strains. No safety concerns were identified; solicited adverse reactions were dose-dependent and more frequent after receipt of mRNA-1010 than the active comparator. These interim data support continued development of mRNA-1010. Here the authors report initial findings of a phase 1 clinical trial, showing that an investigational, mRNA-based vaccine for seasonal influenza (mRNA-1010) has no safety concerns and produces immune responses in adults that are similar or higher than a licensed comparator vaccine.
Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age
In a randomized, placebo-controlled trial involving children 6 months to 5 years of age, the mRNA-1273 vaccine was shown to be safe, and the elicited antibody responses were similar to those in young adults.
Point-of-care ultrasound diagnosis of pediatric cholecystitis in the ED
The diagnosis of cholecystitis or biliary tract disease in children and adolescents is an uncommon occurrence in the emergency department and other acute care settings. Misdiagnosis and delays in diagnosing children with cholecystitis or biliary tract disease of up to months and years have been reported in the literature. We discuss the technique and potential utility of point-of-care ultrasound evaluation in a series of pediatric patients with suspected cholecystitis or biliary tract disease. We present a nonconsecutive case series of pediatric and adolescent patients with abdominal pain diagnosed with cholecystitis or biliary tract disease using point-of-care ultrasound. The published sonographic criteria is 3 mm or less for the upper limits of normal gallbladder wall thickness and is 3 mm or less for normal common bile duct diameter (measured from inner wall to inner wall) in children. Measurements above these limits were considered abnormal, in addition to the sonographic presence of gallstones, pericholecystic fluid, and a sonographic Murphy's sign. Point-of care ultrasound screening detected 13 female pediatric patients with cholecystitis or biliary tract disease when the authors were on duty over a 5-year period. Diagnoses were confirmed by radiology imaging or at surgery and surgical pathology. Point-of-care ultrasound to detect pediatric cholecystitis or biliary tract disease may help avoid misdiagnosis or delays in diagnosis in children with abdominal pain.