Created at Source Raw Value Validated value
Sept. 18, 2021, 5 a.m. usa

inclusion criteria: - have given informed consent by signing the informed consent form (icf) before initiation of any trial-specific procedures. - willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (including those requested by the german and federal governments, e.g., to follow good practices to reduce chances of spreading covid 19), and other requirements of the trial. - have received bnt162 vaccine candidates in the bnt162-01 or bnt162-04 trials. - remain overall healthy (i.e., has not medically deteriorated significantly since participation in the parent trial, is not anticipated to die in the next 26 weeks, and is able to provide blood as specified by the trial without anticipated, deleterious medical consequences) in the clinical judgment of the investigator based on medical history and physical examination. screening clinical laboratory tests are to assess the participants "new baseline" unless required for eligibility. note: in particular, caution should be used with a subject who has a history of cardiovascular disease, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmia. - agree not to enroll in another trial of an imp, starting after visit 0 and continuously until visit 5 (day 50). - less than 18 months have passed since their last imp injection in their parent trial. - if they received 30 µg comirnaty twice in the bnt162-01 trial, visit 1 in this trial is ≥24 weeks after their last imp injection, unless the subject is a cohort 13 transplant subject of the bnt162-01 trial. - if they received any other bnt162 vaccine candidate than comirnaty in the bnt162-01 or bnt162-04 trial or are a cohort 13 transplant subject, visit 1 in this trial is ≥12 weeks after their last imp injection. - have not been diagnosed with sars-cov-2 infection in the 12 weeks prior to day 1 (baseline). participants who screen-fail on this criterion may be rescreened.

inclusion criteria: - have given informed consent by signing the informed consent form (icf) before initiation of any trial-specific procedures. - willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (including those requested by the german and federal governments, e.g., to follow good practices to reduce chances of spreading covid 19), and other requirements of the trial. - have received bnt162 vaccine candidates in the bnt162-01 or bnt162-04 trials. - remain overall healthy (i.e., has not medically deteriorated significantly since participation in the parent trial, is not anticipated to die in the next 26 weeks, and is able to provide blood as specified by the trial without anticipated, deleterious medical consequences) in the clinical judgment of the investigator based on medical history and physical examination. screening clinical laboratory tests are to assess the participants "new baseline" unless required for eligibility. note: in particular, caution should be used with a subject who has a history of cardiovascular disease, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmia. - agree not to enroll in another trial of an imp, starting after visit 0 and continuously until visit 5 (day 50). - less than 18 months have passed since their last imp injection in their parent trial. - if they received 30 µg comirnaty twice in the bnt162-01 trial, visit 1 in this trial is ≥24 weeks after their last imp injection, unless the subject is a cohort 13 transplant subject of the bnt162-01 trial. - if they received any other bnt162 vaccine candidate than comirnaty in the bnt162-01 or bnt162-04 trial or are a cohort 13 transplant subject, visit 1 in this trial is ≥12 weeks after their last imp injection. - have not been diagnosed with sars-cov-2 infection in the 12 weeks prior to day 1 (baseline). participants who screen-fail on this criterion may be rescreened.

July 8, 2021, 4 a.m. usa

inclusion criteria: - have given informed consent by signing the informed consent form (icf) before initiation of any trial-specific procedures. - willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (including those requested by the german and federal governments, e.g., to follow good practices to reduce chances of spreading covid 19), and other requirements of the trial. - have received bnt162 vaccine candidates in the bnt162-01 or bnt162-04 trials and do not have an ongoing imp-related ae. - remain overall healthy (i.e., has not medically deteriorated significantly since participation in the parent trial, is not anticipated to die in the next 26 weeks, and is able to provide blood as specified by the trial without anticipated, deleterious medical consequences) in the clinical judgment of the investigator based on medical history and physical examination. screening clinical laboratory tests are to assess the participants "new baseline" unless required for eligibility. - agree not to enroll in another trial of an imp, starting after visit 0 and continuously until visit 5 (day 50). - less than 18 months have passed since their last imp injection in their parent trial. - if they received 30 µg comirnaty™ twice in the bnt162-01 trial, visit 1 in this trial is ≥24 weeks after their last imp injection. - if they received any other bnt162 vaccine candidate than comirnaty™ in the bnt162-01 or bnt162-04 trial, visit 1 in this trial is ≥12 weeks after their last imp injection. - have not been diagnosed with sars-cov-2 infection in the 12 weeks prior to day 1 (baseline). participants who screen-fail on this criterion only may be rescreened.

inclusion criteria: - have given informed consent by signing the informed consent form (icf) before initiation of any trial-specific procedures. - willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (including those requested by the german and federal governments, e.g., to follow good practices to reduce chances of spreading covid 19), and other requirements of the trial. - have received bnt162 vaccine candidates in the bnt162-01 or bnt162-04 trials and do not have an ongoing imp-related ae. - remain overall healthy (i.e., has not medically deteriorated significantly since participation in the parent trial, is not anticipated to die in the next 26 weeks, and is able to provide blood as specified by the trial without anticipated, deleterious medical consequences) in the clinical judgment of the investigator based on medical history and physical examination. screening clinical laboratory tests are to assess the participants "new baseline" unless required for eligibility. - agree not to enroll in another trial of an imp, starting after visit 0 and continuously until visit 5 (day 50). - less than 18 months have passed since their last imp injection in their parent trial. - if they received 30 µg comirnaty™ twice in the bnt162-01 trial, visit 1 in this trial is ≥24 weeks after their last imp injection. - if they received any other bnt162 vaccine candidate than comirnaty™ in the bnt162-01 or bnt162-04 trial, visit 1 in this trial is ≥12 weeks after their last imp injection. - have not been diagnosed with sars-cov-2 infection in the 12 weeks prior to day 1 (baseline). participants who screen-fail on this criterion only may be rescreened.