Note that participants <18 years of age cannot be enrolled in the EU. What A Day—what's happening, why it matters, and what you can do about it. Listing a study does not mean it has been evaluated by the U.S. Federal Government. ", https://en.wikipedia.org/w/index.php?title=2019–20_Serie_D&oldid=995296863, 2019–20 in European fourth tier association football leagues, Association football events curtailed due to the COVID-19 pandemic, Articles with unsourced statements from January 2021, Creative Commons Attribution-ShareAlike License, This page was last edited on 20 December 2020, at 07:44. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Study record managers: refer to the Data Element Definitions if submitting registration or results information. I club di Serie D, prossimi alla ripresa del campionato dopo un lungo stop, potranno contare su una convenzione stipulata tra LND e FederLab (Associazione Nazionale Strutture Ambulatoriali) per accedere ai test Covid per i propri tesserati a un prezzo agevolato.. Di seguito tutti i dettagli nella nota ufficiale della Lega Nazionale Dilettanti:. Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids. "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? Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit. Brian Beutler. Phase 1 only: Individuals at high risk for severe COVID-19, including those with any of the following risk factors: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. 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, History of chronic smoking within the prior year, Anticipating the need for immunosuppressive treatment within the next 6 months. Choosing to participate in a study is an important personal decision. North Texas Infectious Diseases Consultants, P.A. Pain at the injection site, redness, and swelling as self-reported on electronic diaries.  (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. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Receipt of medications intended to prevent COVID 19. The study will evaluate the safety, tolerability, and immunogenicity of 2 different SARS CoV 2 RNA vaccine candidates against COVID 19 and the efficacy of 1 candidate: The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose). Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit. Scopri su Sky Sport la classifica completa di Serie A 2020/2021 aggiornata in tempo reale 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. 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. regulation. Gianluigi Donnarumma, AC Milan’s starting goalkeeper, has recently added his name to the list of Serie A players with Covid-19 and was therefore absent in … N Engl J Med. ‘Brooklyn Nine-Nine’, ‘Good Girls’ & ‘Never Have I Ever’ Among Universal TV Series Delaying Production Return Amid Covid-19 Surge In Los Angeles Nellie Andreeva 2 days ago. 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 ].