North Texas Infectious Diseases Consultants, P.A. The season was ended in advance by the Italian Football Federation on 20 May 2020, after a two-month suspension, due to the COVID-19 pandemic in Italy. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. More than 30 leading STM publishers have committed to making all of their COVID-19 and coronavirus-related publications immediately accessible. Washington County reported 114 new cases of the coronavirus on Thursday and 124 Friday, for a two-day total of 238, according to the Pennsylvania Department of Health. The reported death toll from the disease climbed by three on Thursday and by four on Friday, reaching a ⦠[Epub ahead of print], Walsh EE, Frenck RW Jr, Falsey AR, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Mulligan MJ, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Türeci Ö, Tompkins KR, Lyke KE, Raabe V, Dormitzer PR, Jansen KU, Şahin U, Gruber WC. December 02, 2020. The composition of the league will involve nine divisions, grouped geographically and named alphabetically. Brian Beutler. Talk with your doctor and family members or friends about deciding to join a study. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19; Phase 1 only: Individuals at high risk for severe COVID-19, including those with any of the following risk factors: Hypertension The 2019â20 Serie C was the sixth season of the unified Serie C division, the third tier of the Italian football league system.The season was scheduled to run from 24 August 2019 to 26 April 2020, however, on 9 March 2020, the Italian government halted the league until 3 April 2020 due to the COVID-19 pandemic in Italy. The season was ended in advance by the Italian Football Federation on 20 May 2020, after a two-month suspension, due to the COVID-19 pandemic in Italy. Gianluigi Donnarumma, AC Milanâs starting goalkeeper, has recently added his name to the list of Serie A players with Covid-19 and was therefore absent in ⦠Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. More than 4.2 million Americans have their first COVID-19 vaccine. At Brill we have opened up books and articles on topics such as public health, distance learning, crisis research. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. J. Lewis Research, Inc. / Foothill Family Clinic, Salt Lake City, Utah, United States, 84109, J. Lewis Research, Inc. / Foothill Family Clinic South, Salt Lake City, Utah, United States, 84121, Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID), Annandale, Virginia, United States, 22003, Midlothian, Virginia, United States, 23114, Benaroya Research Institute at Virginia Mason, Seattle, Washington, United States, 98101, Wenatchee, Washington, United States, 98801, Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich, Hospital Santo Antonio/ Associacao Obras Sociais Irma Dulce, CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda (Casa Branca), CRS Clinical Research Services Berlin GmbH, CRS Clinical Research Services Mannheim GmbH, Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten Drescher, Johannesburg, Gauteng, South Africa, 2113, Tiervlei Trial Centre, Basement Level, Karl Bremer Hospital, Cape Town, Western CAPE, South Africa, 7530, Ankara Universitesi Tip Fakultesi, Ibni Sina Hastanesi, Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi, Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul Universitesi-Cerrahpasa, Cerrahpasa Tip Fakultesi, Sakarya Universitesi Egitim ve Arastirma Hastanesi. Even though researchers around the country quickly began creating tests that could diagnose Covid-19, many said they were hindered by the F.D⦠The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The paper reports, âIf coronavirus restrictions allow, the Royal Family will certainly gather for a private celebration, and the Duke and Duchess of ⦠Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. Republican Silence Is a Bet Against Democracy. For general information, Learn About Clinical Studies. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. NBCUniversal 'The More You Know' COVID-19 Campaign: In partnership with the White House, CDC, and Health and Human Services, NBCUniversal created a series of videos and graphics, available in both English and Spanish, to help educate people around the country about how they can reduce their risk and prevent the spread of COVID-19. Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥12 years, inclusive, at randomization (dependent upon study phase). Choosing to participate in a study is an important personal decision. Afghanistan. Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. Risks of and risk factors for COVID-19 disease in people with diabetes: a cohort study of the total population of Scotland. Serie C did not resume play on this date. Phases 1 and 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). COVID-19 is an emerging, rapidly evolving situation. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. COVID-19. "Stop ai Dilettanti: adesso Palermo, Mantova e le altre aspettano la C", "Ammissioni e ripescaggi ai campionati nazionali della LND", "ECCELLENZA, ECCO LE SQUADRE PROMOSSE IN SERIE D: I VERDETTI", "SPAREGGI ECCELLENZA: ECCO LE SETTE SQUADRE PROMOSSE IN SERIE D", "Stagione Sportiva 2019/2020 Comunicato Ufficiale N° 5 del 18/7/2019", "A Rezzato si chiude un'era Addio serie D: cosa accadrà? Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? (Clinical Trial), Triple (Participant, Care Provider, Investigator), A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS, Experimental: Low dose, 18-55 years of age (2 doses), Experimental: Low-mid dose, 18-55 years of age (2 doses), Experimental: Mid dose, 18-55 years of age (2 doses), Experimental: Low dose, 65-85 years of age (2 doses), Experimental: Low-mid dose, 65-85 years of age (2 doses), Experimental: Mid dose, 65-85 years of age (2 doses), Experimental: Mid dose, ≥12 years of age (2 doses), Placebo Comparator: Placebo, 18-55 years of age, Placebo Comparator: Placebo, 65-85 years of age, Placebo Comparator: Placebo, ≥12 years of age, Experimental: High dose, 18-55 years of age (2 doses), Vaccination of Placebo recipients with BNT162b2 - Stage 1, Vaccination of placebo recipients with BNT162b2 - Stage 2, 12 Years and older (Child, Adult, Older Adult), Birmingham, Alabama, United States, 35216, Huntsville, Alabama, United States, 35801, Huntsville, Alabama, United States, 35802, Alliance for Multispecialty Research, LLC, Chinle Comprehensive Health Care Facility, Johns Hopkins Center for American Indian Health, Whiteriver, Arizona, United States, 85941, Anaheim, California, United States, 92801, Long Beach, California, United States, 90806, Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States, 90027, Los Angeles, California, United States, 90057, North Hollywood, California, United States, 91606, Redding, California, United States, 96001, Sacramento, California, United States, 95815, Sacramento, California, United States, 95817, San Diego, California, United States, 92123-1881, Santa Clara, California, United States, 95051, Valley Village, California, United States, 91607, Walnut Creek, California, United States, 94598, Milford, Connecticut, United States, 06460, Yale Center for Clinical Investigations (CSRU), New Haven, Connecticut, United States, 06519, Coral Gables, Florida, United States, 33134, Fleming Island Center for Clinical Research, Fleming Island, Florida, United States, 32003, Jacksonville Center for Clinical Research, Jacksonville, Florida, United States, 32216, Jacksonville, Florida, United States, 32256, Stockbridge, Georgia, United States, 30281, Bardstown, Kentucky, United States, 40004, Metairie, Louisiana, United States, 70006, New Orleans, Louisiana, United States, 70121, Shreveport, Louisiana, United States, 71101, Shreveport, Louisiana, United States, 71103, Baltimore, Maryland, United States, 21201, University of Maryland, Center for Vaccine Development and Global Health, Center for Immunization Research Inpatient Unit, Baltimore, Maryland, United States, 21224, Boston, Massachusetts, United States, 02118, UMass Memorial Medical Center - University Campus, Worcester, Massachusetts, United States, 01655, Farmington Hills, Michigan, United States, 48334, Gulfport, Mississippi, United States, 39503, Chesterfield, Missouri, United States, 63005, Saint Louis, Missouri, United States, 63141, Bozeman Health Deaconess Hospital dba Bozeman Health Clinical Research, Methodist Physicians Clinic / CCT Research, Wake Research-Clinical Research Center of Nevada, LLC, Raritan, New Jersey, United States, 08869, Somers Point, New Jersey, United States, 08244, Shiprock, New Mexico, United States, 87420, Binghamton, New York, United States, 13901, Rochester, New York, United States, 14609, Rochester Regional Health/Rochester General Hospital, Rochester, New York, United States, 14621, PMG Research of Raleigh, LLC d/b/a PMG Research of Cary, Cary, North Carolina, United States, 27518, Charlotte, North Carolina, United States, 28209, Duke University Medicine Circle- Duke Early Phase Clinical Research Unit, Durham, North Carolina, United States, 27710, Greensboro, North Carolina, United States, 27408, Hickory, North Carolina, United States, 28601, Raleigh, North Carolina, United States, 27609, Raleigh, North Carolina, United States, 27612, Salisbury, North Carolina, United States, 28144, Wilmington, North Carolina, United States, 28401, Winston-Salem, North Carolina, United States, 27103, Fargo, North Dakota, United States, 58104, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229-3039, University Hospitals Cleveland Medical Center, Kaiser Permanente Northwest-Center for Health Research, Lehigh Valley Health Network/Network Office of Research and Innovation, Allentown, Pennsylvania, United States, 18102, Warwick, Rhode Island, United States, 02886, Little River, South Carolina, United States, 29566, Loris, South Carolina, United States, 29569, Dakota Dunes, South Dakota, United States, 57049, Kingsport, Tennessee, United States, 37660, Knoxville, Tennessee, United States, 37920, Nashville, Tennessee, United States, 37203, Tullahoma, Tennessee, United States, 37388. Percentage of participants in Phase 1 reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ], Percentage of participants in Phase 1 reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ], Percentage of participants in Phase 1 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], Percentage of participants in Phase 1 reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ], Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 1 day after dose 1 ], Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 1 ], Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 2 ], Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 1 day after dose 1 ], Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 7 days after dose 1 ], Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between before dose 2 and 7 days after dose 2 ], In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ], In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ], In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ], In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ], In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ], Percentage of participants in Phase 2/3 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], Percentage of participants in Phase 2/3 reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ], Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Percentage of participants 12-15 years of age in Phase 3 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], Percentage of participants 12-15 years of age in Phase 3 reporting adverse events [ Time Frame: From dose 1 through 6 months after the last dose ], In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ], In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ], In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: Through 2 years after the final dose ], In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point [ Time Frame: Through 2 years after the final dose ], Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels [ Time Frame: Through 2 years after the final dose ], In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs [ Time Frame: Through 2 years after the final dose ], Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels [ Time Frame: Through 2 years after the final dose ], In Phase 1 participants, GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from before vaccination to each subsequent time point [ Time Frame: Through 2 years after the final dose ], In Phase 1 participants, GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 (anti-S1 and anti-RBD) binding antibody levels [ Time Frame: Through 2 years after the final dose ], Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age) [ Time Frame: 1 month after the second dose ].
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