A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults ≥75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE networkArticle Published on 2022-10-082022-11-15 Journal: Trials [Category] COVID19(2023년), SARS, 변종, 진단, [키워드] ≥75 years. adaptive addition advanced age age Analysis Antibody titre benefit BNT162b2 BNT162b2 (Comirnaty®) booster booster dose changes in Clinical course collected concern conducted COVID-19 COVID-19 pandemic COVID-19 vaccination COVID-19 vaccine dose Endpoint enzyme-linked immunosorbent evaluate exploratory fourth dose humoral immune response immunosenescence include individual initial Intervention mRNA-1273 mRNA-1273 (Spikevax®) multicentre neutralising neutralising antibody titre Older Part Patient performed phase phase II primary endpoint protocol qPCR Quantitative randomisation randomised randomised controlled reactogenicity Research risk factor SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 vaccine secondary subgroup T cell response the primary endpoint Trial triggered vaccination Vaccine vaccine-induced immune response variants variants of concern VoC wild-type wild-type virus [DOI] 10.1186/s13063-022-06791-y PMC 바로가기
A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202) ☆Original Research Published on 2022-07-082024-09-04 Journal: ESMO open [Category] 대상포진, [키워드] anal cancer clinical trial INCMGA00012 PD-(L)1 inhibitor phase II retifanlimab [DOI] 10.1016/j.esmoop.2022.100529 PMC 바로가기 [Article Type] Original Research
ACCORD: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients: A structured summary of a study protocol for a randomised controlled trialACCORD: 입원 환자의 COVID-19 치료를 위한 여러 후보 약제의 효능과 안전성을 평가하기 위한 다기관, 원활한, 2상 적응형 무작위화 플랫폼 연구: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약Letter Published on 2020-07-312022-08-13 Journal: Trials [Category] SARS, 임상, [키워드] 1:1 a BTK inhibitor Acalabrutinib adaptive added adjusted agent Amendment analyses Analysis Anti-viral approval Arm baseline bemcentinib Blinding block BTK inhibitor candidate Candidates cause caused changed clinical Clinical characteristics Clinical improvement clinically comparator complement COVID COVID-19 current Day discharge disease dissemination dropped Efficacy element Endpoint England estimation EudraCT evaluate Evidence evidence of experimental arm GRADE group help heparin hospital hospitalised include Inflammatory response inhibitor Ireland IRT Mask Master protocol Mild Mild disease monoclonal antibody Multiple nasal prongs National non-invasive ventilation number objective open open label Ordinal Scale outcome oxygen Oxygen therapy oxygen therapy) participant Patient performed Phase 2 phase II platform proceed protocol protocols provide randomisation randomised randomised controlled randomised controlled trial randomization recruited recruitment reduce Registered Regulatory reported Respiratory failure response response rate Safety Sample size SARS-COV-2 infection SARS-CoV-2 spike SARS-CoV-2 spike protein seamless selected severity shown SOC Spike protein Stage stage 2 stages Standard of care status stratified Study protocol sustained Task Force technology the spike protein the WHO therapy time treat Treatment treatment of COVID-19 Trial Trial registration Viral viral infection virus website with COVID-19 working zilucoplan [DOI] 10.1186/s13063-020-04584-9 PMC 바로가기 [Article Type] Letter
Clinical and Immune Responses to Inactivated Influenza A(H1N1)pdm09 Vaccine in ChildrenArticle Published on 2014-06-232023-06-23 Journal: The Pediatric Infectious Disease Journal [Category] 신종인플루엔자, [키워드] adverse effects children Inactivated Vaccines Infants Influenza vaccines/immunology pandemic phase II randomized trial [DOI] 10.1097/INF.0000000000000329 PMC 바로가기 [Article Type] Article