Created at Source Raw Value Validated value
June 25, 2024, noon usa

any clinically significant abnormal finding on clinical examination or laboratory screening tests according to the us food and drug administration (fda) toxicity grading scale for healthy adult and adolescent subjects enrolled in preventative vaccine clinical trials \[30\]. 2. history of covid-19 infection. 3. chronic use of immunosuppressive drugs or other immune modifying drugs within six months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period. 4. positive urine toxicology test for cannabis, cocaine or amphetamines at inclusion. 5. screening tests positive for sars-cov-2, sars-cov-2 antibodies, human immunodeficiency virus (hiv), active hepatitis b virus (hbv), or hepatitis c virus (hcv). 6. receipt of any investigational or non-registered product (drug or vaccine) other than the study product in the 30 days preceding enrolment or during the study period. 7. participation in any other clinical study in the 30 days prior to the start of the study or during the study period. 8. immunization with any vaccines within the past four weeks or planned receipt of a vaccine during the study period with the exception of a licensed sars-cov-2 vaccine, given within the framework of the national sars-cov-2 vaccination campaign. the time between last vaccination with abncov2 and a sars-cov-2 vaccine provided by the campaign shall be at least 4 weeks. 9. known hypersensitivity to any of the vaccine components (adjuvant or protein). 10. administration of immunoglobulins and/or any blood products within the three months prior to the first dose of abncov2 or planned administration during the study period. 11. previous participation in a covid-19 vaccine study. 12. body mass index (bmi) \>35 kg/m2. 13. pregnancy, lactation or intention to become pregnant during the study period. 14. history of drug or alcohol abuse interfering with normal functioning in the five years preceding enrolment. 15. being an employee or student of the department of medical microbiology of the radboudumc, or a person otherwise related to the investigator other than a professional relationship for clinical trial purpose only. 16. any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

any clinically significant abnormal finding on clinical examination or laboratory screening tests according to the us food and drug administration (fda) toxicity grading scale for healthy adult and adolescent subjects enrolled in preventative vaccine clinical trials \[30\]. 2. history of covid-19 infection. 3. chronic use of immunosuppressive drugs or other immune modifying drugs within six months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period. 4. positive urine toxicology test for cannabis, cocaine or amphetamines at inclusion. 5. screening tests positive for sars-cov-2, sars-cov-2 antibodies, human immunodeficiency virus (hiv), active hepatitis b virus (hbv), or hepatitis c virus (hcv). 6. receipt of any investigational or non-registered product (drug or vaccine) other than the study product in the 30 days preceding enrolment or during the study period. 7. participation in any other clinical study in the 30 days prior to the start of the study or during the study period. 8. immunization with any vaccines within the past four weeks or planned receipt of a vaccine during the study period with the exception of a licensed sars-cov-2 vaccine, given within the framework of the national sars-cov-2 vaccination campaign. the time between last vaccination with abncov2 and a sars-cov-2 vaccine provided by the campaign shall be at least 4 weeks. 9. known hypersensitivity to any of the vaccine components (adjuvant or protein). 10. administration of immunoglobulins and/or any blood products within the three months prior to the first dose of abncov2 or planned administration during the study period. 11. previous participation in a covid-19 vaccine study. 12. body mass index (bmi) \>35 kg/m2. 13. pregnancy, lactation or intention to become pregnant during the study period. 14. history of drug or alcohol abuse interfering with normal functioning in the five years preceding enrolment. 15. being an employee or student of the department of medical microbiology of the radboudumc, or a person otherwise related to the investigator other than a professional relationship for clinical trial purpose only. 16. any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

April 11, 2021, 12:31 a.m. usa

any clinically significant abnormal finding on clinical examination or laboratory screening tests according to the us food and drug administration (fda) toxicity grading scale for healthy adult and adolescent subjects enrolled in preventative vaccine clinical trials [30]. 2. history of covid-19 infection. 3. chronic use of immunosuppressive drugs or other immune modifying drugs within six months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period. 4. positive urine toxicology test for cannabis, cocaine or amphetamines at inclusion. 5. screening tests positive for sars-cov-2, sars-cov-2 antibodies, human immunodeficiency virus (hiv), active hepatitis b virus (hbv), or hepatitis c virus (hcv). 6. receipt of any investigational or non-registered product (drug or vaccine) other than the study product in the 30 days preceding enrolment or during the study period. 7. participation in any other clinical study in the 30 days prior to the start of the study or during the study period. 8. immunization with any vaccines within the past four weeks or planned receipt of a vaccine during the study period with the exception of a licensed sars-cov-2 vaccine, given within the framework of the national sars-cov-2 vaccination campaign. the time between last vaccination with abncov2 and a sars-cov-2 vaccine provided by the campaign shall be at least 4 weeks. 9. known hypersensitivity to any of the vaccine components (adjuvant or protein). 10. administration of immunoglobulins and/or any blood products within the three months prior to the first dose of abncov2 or planned administration during the study period. 11. previous participation in a covid-19 vaccine study. 12. body mass index (bmi) >35 kg/m2. 13. pregnancy, lactation or intention to become pregnant during the study period. 14. history of drug or alcohol abuse interfering with normal functioning in the five years preceding enrolment. 15. being an employee or student of the department of medical microbiology of the radboudumc, or a person otherwise related to the investigator other than a professional relationship for clinical trial purpose only. 16. any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

any clinically significant abnormal finding on clinical examination or laboratory screening tests according to the us food and drug administration (fda) toxicity grading scale for healthy adult and adolescent subjects enrolled in preventative vaccine clinical trials [30]. 2. history of covid-19 infection. 3. chronic use of immunosuppressive drugs or other immune modifying drugs within six months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period. 4. positive urine toxicology test for cannabis, cocaine or amphetamines at inclusion. 5. screening tests positive for sars-cov-2, sars-cov-2 antibodies, human immunodeficiency virus (hiv), active hepatitis b virus (hbv), or hepatitis c virus (hcv). 6. receipt of any investigational or non-registered product (drug or vaccine) other than the study product in the 30 days preceding enrolment or during the study period. 7. participation in any other clinical study in the 30 days prior to the start of the study or during the study period. 8. immunization with any vaccines within the past four weeks or planned receipt of a vaccine during the study period with the exception of a licensed sars-cov-2 vaccine, given within the framework of the national sars-cov-2 vaccination campaign. the time between last vaccination with abncov2 and a sars-cov-2 vaccine provided by the campaign shall be at least 4 weeks. 9. known hypersensitivity to any of the vaccine components (adjuvant or protein). 10. administration of immunoglobulins and/or any blood products within the three months prior to the first dose of abncov2 or planned administration during the study period. 11. previous participation in a covid-19 vaccine study. 12. body mass index (bmi) >35 kg/m2. 13. pregnancy, lactation or intention to become pregnant during the study period. 14. history of drug or alcohol abuse interfering with normal functioning in the five years preceding enrolment. 15. being an employee or student of the department of medical microbiology of the radboudumc, or a person otherwise related to the investigator other than a professional relationship for clinical trial purpose only. 16. any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.