Trial participation was up to 3 years. NOXXON annonce la fin du recrutement des patients de la première cohorte de l'essai clinique de phase I/II evaluant NOX-A12 en combinaison avec la radiothérapie pour le traitement du cancer du cerveau : 2019, Decembre 20 8:00 heures: Phase. On distingue 4 phases dans les essais cliniques : Phase I. Lors de la phase 1, les essais sont, généralement, réalisés chez le volontaire sain (c’est-à-dire non malade). Closed. 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. AURA Phase I/II AURA2 Phase II Not eligible for enrollment Patients with T790M-positive aNSCLC whose disease has progressed following either one prior therapy with an EGFR-TKI or following treatment with both EGFR-TKI and other anticancer therapy Pooled Phase II Yang JCH, et al. Essais cliniques sur Syndrome d'hamartome, multiple. N Engl J Med. Pour en savoir plus, lire Les essais de phase précoce aux pag… Pain at the injection site, redness, and swelling as self-reported on electronic diaries. Methods: This is a randomized (1:1), double-blind, placebo-controlled trial of riluzole 50 mg twice daily in subjects with MS onset less than 1 year prior. Par ailleurs, Santé Canada fournit des renseignements sur les essais cliniques aux Canadiennes et aux Canadiens pour qu'ils puissent prendre des décisions en toute connaissance de cause. 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. 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. Ces essais ont lieu dans des centres spécialisés qui ont reçu un agrément de la part des autorités de santé. An Open-Label, Multicenter, Phase 1 Study of Ramucirumab plus Pembrolizumab in Patients with Locally Advanced and Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Non-Small Cell Lung Cancer, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer. This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. Objectives: We evaluated the effect of riluzole versus placebo added to weekly IM interferon beta-1a in early multiple sclerosis (MS). L’essai clinique de phase I/II est un essai randomisé, en double aveugle, contrôlé par placebo, visant à évaluer les profils de sécurité, de tolérance et de réponse immunitaire du candidat-vaccin que Sanofi et GSK développent contre le COVID-19. To obtain contact information for a study center near you, click here. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Chez les patients âgés atteints de cette maladie, le protocole standard est moins efficace et moins bien toléré que chez les patients plus jeunes. Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention. Abbreviated Title. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. Ils doivent se faire dans le respect des bonnes pratiques cliniques et être fondés sur des bases scientifiques solides et légitimées en accord avec les principes éthiques énoncés dans la … 1. Phase 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality. 2021 à partir de Titre Un essai clinique de phase I/II pour étudier la sécurité et la tolérabilité de combinaisons de régimes de traitements de MK-3475 et de l’interféron-alfa-2b pégylé (PEG-IFN) et de MK-3475 et d’Ipilimumab (IPI) Ad26.COV2.S, a COVID-19 vaccine based on a human replication-incompetent Ad26 vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus spike (S) protein, is being developed. Our clinical trials. 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. Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19. The primary endpoint was change in percent brain volume change. ;EXPRESS : EXcePtional RESponSe, OPEN, NON CONTROLLED, MULTICENTER, FIRST-IN-HUMAN STUDY FOR THE EVALUATION OF THE SAFETY, PHARMACOKINETICS AND PRELIMINARY ANTITUMOR ACTIVITY OF GM102 IN PATIENTS WITH ADVANCED PRETREATED GYNECOLOGICAL CANCER. Les essais de phase I incluent un petit nombre de sujets volontaires, le plus souvent sains. 2020 Oct;586(7830):589-593. doi: 10.1038/s41586-020-2639-4. Nos essais cliniques Our clinical trials. 2020 Dec 17;383(25):2439-2450. doi: 10.1056/NEJMoa2027906. L'essai de la phase 0 est le premier test clinique humain d'un médicament neuf et non essayé. 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. b) Phase II : - la phase II A (phase II précoce) permet d'étudier, chez l'homme, la (les) propriété(s) pharmacodynamique(s) dont celles déjà mises en … 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. 2021 Jan 19;:. Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit. Seules certaines personnes sont susceptibles de suivre cet essai clinique. Pre-operative window-of-opportunity study of Debio 1143 with or without cisplatin in patients with resectable squamous cell carcinoma of the head and neck. Receipt of medications intended to prevent COVID 19. A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (Lirilumab) Administered in Combination with Anti-PD-1 (Nivolumab) in;Advanced Refractory Solid Tumors. Phase I/IIa, Open-Label, Dose-Escalation Study of Safety and Tolerability of Intravitreal RST-001 in Patients With Advanced Retinitis Pigmentosa (RP) Actual Study Start Date : December 14, 2015. TOKYO, April 9, 2020 — FUJIFILM Corporation (President: Kenji Sukeno) announces the initiation of a U.S. phase II clinical trial to evaluate the safety and efficacy of its influenza antiviral drug “Avigan® Tablet” (generic name: favipiravir) for patients with COVID-19, a respiratory infection caused by the novel SARS-CoV-2 coronavirus. Une phase de préparation qui consiste à écrire de manière très précise la question scientifique à laquelle on souhaite répondre et à rédiger le protocole de recherche correspondant. Pour les essais cliniques de phase précoce, en particulier les essais réalisés pour la première fois sur l’homme, le principal objectif est en général d’identifier une dose sûre, History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). more_vert 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. L’équipe en charge de l’essai clinique est à même de voir si vous pouvez suivre l’essai. 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. Paris. Epub 2020 Oct 14. Essai Clinique Généré le 12 nov. 2020 à partir de Titre Une étude de phase I/II avec escalade de dose et expansion ayant pour but d’évaluer la sécurité, la pharmacocinétique, la pharmacodynamique et l’activité clinique du GSK525762 associé au fulvestrant chez des patientes atteintes d’un cancer du sein ER+ Protocole ID GSK201973 A phase I/II open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in subjects with NUT midline carcinoma(NMC) and other cancers. Ces essais cliniques sont en cours en Europe, en Asie et au Canada. A Phase I/II randomised study to determine the maximum tolerated dose, safety, pharmacokinetics and antitumor activity of Debio 1143 combined with concurrent chemo-radiation therapy in patients with locally advanced squamous cell carcinoma of the head and neck. Note that participants <18 years of age cannot be enrolled in the EU. Objectifs de l'essai. A phase I/II open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in subjects with NUT midline carcinoma (NMC) and other cancers. Les essais de phase III sont réalisés sur un grand nombre (plusieurs centaines et plusieurs milliers) de volontaires malades.Les patients éligibles sont généralement définis sur des caractéristiques démographiques (âge), cliniques (stade et forme de la maladie, co-morbidités) et thérapeutiques (autres traitements antérieurs ou en cours). The SAT‐1 trial was an investigator‐initiated, phase I/II, double‐blind, placebo‐controlled, randomized clinical trial to examine the safety and activity of single‐dose suramin or placebo in 10 children with autism spectrum disorders (ASD). Un compromis entre toutes ces méthodes est suggéré. Cette étude de phase I/II vise à évaluer un nouveau traitement du lymphome de Hodgkin chez des personnes âgées. L’essai de phase II est mené sur un petit groupe homogène de volontaires atteints de la maladie ciblée. Talk with your doctor and family members or friends about deciding to join a study. La stratégie de l'entreprise comprend également un essai dans le cancer de la prostate qui devrait être lancé plus tard aux États-Unis. 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. ICH GCP. phase I/II dans les cancers du foie métastatique, un essai de phase I/II dans les carcinomes hépatocellulaires (HCC) et un essai de phase I/II dans le cancer du rectum (par PharmaEngine). French Des essais cliniques ont été effectués en Afrique du Sud, au Kenya et en Ouganda. Celui-ci doit être ensuite soumis à l’avis du Comité de protection des personnes (CPP) et à l’autorisation de l’Agence nationale pour la sécurité du médicament et des produits de santé (ANSM). Essai précoce dans le traitement du cancer du poumon non à petite cellule 73841937NSC1001 Etude en ouvert de phase 1 / 1b afin d'évaluer la sécurité d¿emploi et la... Médecin investigateur Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. phase I/II dans les cancers du foie métastatique, un essai de phase I/II dans les carcinomes hépatocellulaires (HCC) et un essai de phase I/II dans le cancer du rectum (par PharmaEngine). Les phases précoces ont pour objectif d'évaluer la tolérance et le devenir du médicament dans l'organisme, ainsi que les éventuels effets secondaires afin … Phase. Accrual. Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. On y recrute de 10 à 100 volontaires en santé qui reçoivent différentes doses du vaccin. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Essais cliniques de phase I comme sujet. Vers de nouveaux traitementsUn essai clinique précoce (ou essai de phase I) consiste à évaluer la sécurité d’emploi d’une nouvelle molécule (administrée seule ou en association avec une autre thérapie), son devenir dans l’organisme, les effets indésirables qu’elle peut produire chez l’homme et à obtenir les premiers éléments de son activité anti-tumorale.Les essais précoces L'objectif est Nature. Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Raabe V, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Türeci Ö, Tompkins KR, Walsh EE, Frenck R, Falsey AR, Dormitzer PR, Gruber WC, Şahin U, Jansen KU. Phase III (6) Etude clinique (2) Phase I (2) Phase I/II (2) Phase II (2) Phase II/III (1) (-) Essai. Epub 2020 Aug 12. L’essai clinique de phase I/II est un essai randomisé, en double aveugle, contrôlé par placebo, ayant pour but d’évaluer les profils de sécurité, de réactogénicité (tolérance) et d’immunogénicité (réponse immunitaire) du candidat-vaccin contre la COVID-19. Les essais contrôlés randomisés (ECR) constituent la référence pour évaluer l’efficacité d’une intervention.  (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. Phase Ib/II trial of copanlisib, a selective PI3K inhibitor, in combination with cetuximab in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) harboring a PI3KCA mutation/amplification and/or a PTEN loss. COVID-19 is an emerging, rapidly evolving situation. 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. https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. Estimated Study Completion Date : … La molécule est testée sur une courte période. Methods: This is a randomized (1:1), double-blind, placebo-controlled trial of riluzole 50 mg twice daily in subjects with MS onset less than 1 year prior. Essai(s) clinique(s) national(aux) ... CSOM230D2203: An open label, multicentre, single arm phase II study of Pasireotide LAR in patients with Rare Tumors of Neuroendocrine Origin - DE. Un essai de phase I/II vise à démontrer la faisabilité, la tolérance et si possible l'efficacité d'un traitement en cours d'évaluation chez l'homme.Lire sur le même sujetEssais cliniques et maladies neuromusculaires, Repères Savoir & Comprendre, AFM-Téléthon.Les 4 phases d'un essai cliniqueDéfinition de essai clinique sur l'encyclopédie Wikipédia Erratum in: Nature. ELCC 2016; Abstract LBA2_PR Phase II Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention. Ces études ont deux objectifs majeurs : II. Quatorze patients ont été traités à ce jour dans les essais des phases I et II (REO 011). Study record managers: refer to the Data Element Definitions if submitting registration or results information. Les essais cliniques de phase 0 sont régis par les mêmes règles que tout essai clinique. Études cliniques. Canada should be contributing to this research with our own Phase II clinical trials. Un essai clinique précoce (phase I ou II) correspond aux premières phases d'administration d'un nouveau médicament à l'Homme. > essai clinique. La durée d’une phase II est généralement de deux à trois ans, dépendant de la pathologie sélectionnée et du nombre de malades. Phase I: Dose-ranging on healthy volunteers for safety Often subtherapeutic, but with ascending doses Clinical researcher 20–100 normal healthy volunteers (or cancer patients for cancer drugs) Approx. springer. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Mots-clés : Essai clinique – Phase I – Phase II – Phase III – Oncologie. N Engl J Med. 2019 Annual Report: Another Step Towards the Comprehensive Cancer Center of the Future, Developing the Radiotherapy of the Future. Les essais de phase 1 constituent la première étape d’évaluation d’un vaccin chez l’humain. Filter by: Hématologie Leucémie (-) Phase II/III (-) Filter by. 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 ], Incidence of asymptomatic SARS CoV-2 infection based on N binding antibody seroconversion in participants with no serological or virological evidence of past SARS CoV-2 infection or confirmed COVID-19 prior to 1 month after receipt of the second dose [ Time Frame: Through 1 month after the second dose ], Incidence of asymptomatic SARS CoV-2 infection based on central laboratory-confirmed NAAT in participants with no serological or virological evidence (up to the start of the asymptomatic surveillance period) of past SARS-CoV-2 infection [ Time Frame: Through 6 months after the second dose ].

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