At Brill we have opened up books and articles on topics such as public health, distance learning, crisis research. ClinicalTrials.gov Identifier: NCT04368728, Interventional Information provided by (Responsible Party): Participants ≥16 years of age who originally received placebo and are eligible for COVID-19 vaccination following any local or national recommendations will be offered the opportunity to receive BNT162b2 as part of the study. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Differences, similarities between first two coronavirus vaccinations authorized in U.S. 5 Ways the Pandemic Will Be Different in 2021 Look for innovations in COVID …  (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. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 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. 6 points deducted due to financial irregularities. 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). Republican Silence Is a Bet Against Democracy. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. What A Day—what's happening, why it matters, and what you can do about it. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. The composition of the league will involve nine divisions, grouped geographically and named alphabetically. Choosing to participate in a study is an important personal decision. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. ", 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. Due to a continuing combination of positive COVID-19 tests, contact tracing and subsequent quarantining of individuals within the Omaha hockey program, the Omaha at North Dakota series scheduled for this weekend, Friday, Jan. 8 and Saturday, Jan. 9, at Ralph Engelstad Arena in Grand Forks, N.D. has been postponed. Twenty-eight clubs were promoted from the Eccellenza as league winners, plus one as the Coppa Italia Dilettanti winners and seven more as national playoff winners. 2020 Dec 10. doi: 10.1056/NEJMoa2034577. Les chercheurs ont comparé les symptômes des enfants positifs au Covid-19, à ceux d'enfants négatifs à la maladie. Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids. COVID-19 is an emerging, rapidly evolving situation. 2020 Oct;586(7830):589-593. doi: 10.1038/s41586-020-2639-4. Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19. Série d'allocutions de l'ACSP sur les enjeux liés à la COVID-19 OTTAWA, ON, le 13 déc. Cuneo, originally relegated to Serie D, declined to their right to participate in the season,[2] whereas Virtus Verona, Fano, Paganese and Bisceglie were readmitted to Serie C in order to fill various vacancies. Subscribe to our nightly newsletter . Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. The paper reports, “If coronavirus restrictions allow, the Royal Family will certainly gather for a private celebration, and the Duke and Duchess of … Scopri su Sky Sport la classifica completa di Serie A 2020/2021 aggiornata in tempo reale Protocollo Covid in Serie D: accordo Lnd – Federlab - YouTube Individual Participant Data (IPD) Sharing Statement: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. Your home for CNN's podcasts, showcasts and livestreams. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. [5], On 31 July 2019, the Lega Nazionale Dilettanti announced to have admitted Agropoli, Legnago Salus, Pomezia, Olympia Agnonese, Legnano, Gladiator, Tamai and Anagni to fill in all the league vacancies. regulation. Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. Brian Beutler. 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. [1] On 22 May, the Lega Nazionale Dilettanti formally proposed the nine first-placed teams for promotion to Serie C, with the four bottom teams in each group as the ones to be relegated in the Eccellenza league. More than 30 leading STM publishers have committed to making all of their COVID-19 and coronavirus-related publications immediately accessible. Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel). 2020 Oct 14. doi: 10.1056/NEJMoa2027906. Findings In this case series that included 5700 patients hospitalized with COVID-19 in the New York City area, the most common comorbidities were hypertension, obesity, and diabetes. Positions determined on head-to-head points: Nocerina 8, Grumentum 5, Nardò 2. To obtain contact information for a study center near you, click here. Note that participants <18 years of age cannot be enrolled in the EU. The 2019–20 Serie D was the seventy-second edition of the top level Italian non-professional football championship. Previous participation in other studies involving study intervention containing lipid nanoparticles. Microsite. Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates. Pain at the injection site, redness, and swelling as self-reported on electronic diaries. Selena Gomez Slams Facebook for Coronavirus Misinformation The "Rare" singer calls out the company for allegedly allowing false claims about COVID … 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 … COVID-19. Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. For general information, Learn About Clinical Studies. It represents the fourth tier in the Italian football league system. [2], Rezzato, Francavilla and Gela opted not to register to the Serie D season.[6][2]. 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 Sammaurese were originally relegated on points per game: Crema 1.042, Sammaurese 1.040. U.S. Department of Health and Human Services. Risks of and risk factors for COVID-19 disease in people with diabetes: a cohort study of the total population of Scotland. Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries. Neera Tanden or Bust. N Engl J Med. 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. ‘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. COVID-19 Support Group: Confronting the Emotional Challenges of Illness Jul 21, 2020 We reached out to our members to ask how they navigate the fear, uncertainty, sadness, numbness, anger, and despair that are common features of the long-haul experience. [Epub ahead of print]. This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. North Texas Infectious Diseases Consultants, P.A. https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. As elicited by investigational site staff. Phase 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality. The 2019–20 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. N Engl J Med. Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit. 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). 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. Positions determined on head-to-head points per game: Bra 2.000, Ghivizzano 1.333, Fezzanese 0.500. 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 ]. Due to what the league called a combination of positive COVID-19 tests, contact tracing and subsequent quarantining of individuals within the UNO program, the series will shift to late January. Serie C did not resume play on this date. Even though researchers around the country quickly began creating tests that could diagnose Covid-19, many said they were hindered by the F.D… Nature. Afghanistan. The Immense Stakes of the Biden COVID Response. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. ... D360’s Bad Ideas in National Security series features short articles from CSIS and outside scholars on recently considered and not too obvious bad ideas in the defense and foreign policy space. [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.