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Efficacy, immunogenicity, and safety evaluation of an MF59-adjuvanted quadrivalent influenza virus vaccine compared with non-adjuvanted influenza vaccine in children: a multicentre, randomised
BACKGROUND Young children have immature immune systems and respond poorly to standard influenza vaccines. The oil-in-water emulsion adjuvant MF59 can increase antigen uptake, macrophage recruitment,Expand
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Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence
BackgroundClinicians are required to assimilate, critically evaluate, and extrapolate information to support appropriate use of biosimilars across indications.ObjectivesThe objective of this studyExpand
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Assessing the Value of Biosimilars: A Review of the Role of Budget Impact Analysis
Biosimilar drugs are highly similar to an originator (reference) biologic, with no clinically meaningful differences in terms of safety or efficacy. As biosimilars offer the potential for lowerExpand
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Statistical Primer on Biosimilar Clinical Development
A biosimilar is highly similar to a licensed biological product and has no clinically meaningful differences between the biological product and the reference (originator) product in terms of safety,Expand
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P-075 Systematic Review of Evidence for Monoclonal Antibody Biosimilars for the Treatment of Inflammatory Bowel Disease
Background: Several biosimilars are in development or marketed for a number of chronic inflammatory indications, including Crohn’s disease (CD), and ulcerative colitis (UC). Biosimilars are expectedExpand
A Cost/Benefit Analysis of Clinical Trial Designs for COVID-19 Vaccine Candidates
We compare and contrast the expected duration and number of infections and deaths averted among several designs for clinical trials of COVID-19 vaccine candidates, including traditional randomizedExpand
A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates.
We compare and contrast the expected duration and number of infections and deaths averted among several designs for clinical trials of COVID-19 vaccine candidates, including traditional and adaptiveExpand
Comparability of Antibody Titers Determined by Hemagglutination Inhibition and Microneutralization Assays Against Seasonal Influenza Strains.
We compared hemagglutination inhibition (HI) and microneutralization (MN) assays pre- and post-vaccination antibody titers against A/H1N1, A/H3N2, and B influenza strains using data from two vaccineExpand
Comparability of Titers of Antibodies against Seasonal Influenza Virus Strains as Determined by Hemagglutination Inhibition and Microneutralization Assays
We compared titers of antibodies against A/H1N1, A/H3N2, and B influenza virus strains collected pre- and postvaccination using hemagglutination inhibition (HI) and microneutralization (MN) assaysExpand