This is the first phase 3 trial comparing robot-assisted cystectomy with open cystectomy for any urological cancer. 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. Participants will be instructed on how to record daily temperature using a thermometer provided for home use. Currently, there are no approved vaccines for the prevention of COVID-19. ... PP=per-protocol. Un homme est en état de mort cérébrale et cinq autres personnes sont hospitalisées ce vendredi à Rennes, suite à l'essai clinique d'un médicament. Serologic conversion between baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccination using an ELISA and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 nucleocapsid (N) protein will be reported. mITT=modified intention-to-treat. The protocol approved by ANSM on June 2015 was subjected to a modification request in October. 4 0 obj Evidence before this study. Title: … 4. Fever is defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection. Participants will be asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post each vaccination (day of each vaccination and the subsequent 7 days). %�o��]��>�Ѐ'j#jKG��c?��� Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary. 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. 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Part 1 employs a dose-escalation design to determine the recommended phase 2 dose. 2021 à partir de Titre A Randomized, Phase III Trial of Immunization With IMM-101 Versus Observation for the Prevention of Severe Respiratory and COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure Protocole ID COV-IMMUNO (IC8) ClinicalTrials.gov ID NCT04442048 Type(s) de cancer Autre Phase Phase III Type étude Prévention Essai Clinique Généré le 06 janv. Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO), linked to objective measures such as decreased oxygenation, X-ray, computed tomographic [CT] findings) and linked to any molecularly confirmed COVID-19 at least 14 days after the second vaccination will be reported. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus [ Time Frame: 1 day after the 1st vaccination (Day 2) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus [ Time Frame: 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline [ Time Frame: 1 day after the 1st vaccination (Day 2) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline [ Time Frame: 14 days after the 1st vaccination (Day 15) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of COVID-19 Requiring Medical Intervention [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants with Molecularly Confirmed, Moderate to Severe/Critical COVID-19 [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Mild COVID-19 [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly confirmed COVID-19 Defined by the US FDA Harmonized Case Definition [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Serologic Conversion Between Baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccination Using an Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Between baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccination ], Number of Participants with First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 2 years and 3 months ], Number of Participants with Medically-attended Adverse Events (MAAEs) [ Time Frame: 6 months after second vaccination (Up to 34 weeks) ], Number of Participants with Medically-attended Adverse Events (MAAEs) Leading to Study Discontinuation [ Time Frame: Up to 2 years and 3 months ], Number of Participants with Solicited Local Adverse Events (AEs) During 7 Days Following Each Vaccination [ Time Frame: Up to Day 8 (7 days after first vaccination on Day 1), up to Day 64 (7 days after second vaccination on Day 57) ], Number of Participants with Solicited Systemic AEs During 7 Days Following Each Vaccination [ Time Frame: Up to Day 8 (7 days after first vaccination on Day 1), up to Day 64 (7 days after second vaccination on Day 57) ], Number of Participants with Unsolicited Local Adverse Events (AEs) During 28 Days Post-vaccination [ Time Frame: Up to Day 29 (28 days after first vaccination on Day 1), up to Day 85 (28 days after second vaccination on Day 57) ], SARS-CoV-2 Binding Antibodies Assessed by ELISA [ Time Frame: Up to 2 years and 3 months ], SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) [ Time Frame: Up to 2 years and 3 months ], Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies, All participants of childbearing potential must: have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration, Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine, Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study, Must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the coronavirus disease-2019 [COVID 19] signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs), Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (100.4-degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor, Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients, Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine, Participant previously received a coronavirus vaccine, Participant received an investigational drug within 30 days (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or investigational monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study. The Phase 3 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a single vaccine dose of the Janssen investigational COVID-19 vaccine candidate. Participants will receive intramuscular (IM) injection of Ad26.COV2.S vaccine on Day 1 and Day 57. Title: Protocole … This is followed by Part 2, which involves parallel dosing of 3 different cohorts at the dose determined in Part 1. Molecularly confirmed mild COVID-19 is defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. To learn how to participate in this trial please click here. Psilocybin Delivers ‘Remarkable’ Relief in Severe Depression, Batya Swift Yasgur, 2020. 3. A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib: Protocole ID : intrigue (DCC-2618-03-002) ClinicalTrials.gov ID : NCT03673501: Type(s) de cancer : Tumeur stromale gastro-intestinale: Phase : Phase III: Stade The molecule proved most effective in phase 3, will be tested ‘in vivo’ in order to evaluate its ability to correct the tested molecular aberrations. %���� 3�[bh��Gj�5%� ��I���6��|y�lu��� 4��xmD*k'K+�ܭu���}H2������`�|�?B�X�1�4�*B�Z�H���$ ����*��|p$Y�7� �����h�CQm=N���?�������aP�1��O�I��Ǖ�4��`����/�[�E�z COVID-19 is an emerging, rapidly evolving situation. By: ... including the study protocol. Les essais de phase I/II sont une variante des essais de phase I, ils permettent une évaluation préliminaire de l'efficacité à la dose sélectionnée ou bien de tester des combinaisons de médicaments. This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.