Define Phase III Clinical. Trial shall mean a pivotal multi-center human clinical trial in a large number of patients to establish safety or efficacy in the particular claim and indication tested and required to obtain Regulatory Approval.
The HALT-C trial was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH. Initial study funding began in November 1999, with 10 clinical center sites (CCs) contracted across the United States. Separately, NIDDK funded a central specimen repository (Sera...
Major milestone for GSK/NIH candidate Ebola vaccine as first doses shipped to Liberia for use in phase III clinical trial - European Pharmaceutical ReviewMoncef Slaoui
Johnson & Johnson (NYSE: JNJ) (the Company) announced top line efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Phar...
Phase 3 randomized controlled trials (RCTs), while the gold standard for treatment efficacy and safety, are not always feasible, are expensive, can be prolonged and can be limited in generalizability. Other under-recognized sources of evidence can also h
In addition, safety and immunogenicity up to 12 months after vaccination of the rVSV∆G-ZEBOV-GP and ChAd3-EBO Z vaccine have been evaluated in a phase 2, placebo-controlled trial of adults in Liberia (Partnership for Research on Ebola Virus in Liberia I [PREVAIL I]) [7]. The ...
Janssen Vaccines & Prevention B.V.* Clinical Protocol Protocol Title A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE Protocol VAC31518...
but lower efficacy against COVID-19 infection as expected during the Omicron wave and consistent with adult observational data. Using the Phase 3 COVE study COVID-19 definition, vaccine efficacy in children 6 months to ...
For example, persistent post-concussion syndrome occurs after 3 months according to the DSM-IV-TR [59], but after only 1 month according to the ICD-10 [60]. This variability has been evoked in the past, and authors have suggested standardization [61–63]. Moreover, the NIH, through the...
trial, the patients maintained either one (load 1) or three (load 3) consecutively presented pictures in their WM for 2.5–2.8 s (Fig.1a). The patients were then asked whether a probe stimulus shown was identical to one of the item(s) they were holding in WM. Mean accuracy was 93...