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

subjects to whom any of the following applies will be excluded from the study: 1. any clinically significant abnormality or vital sign abnormality at physical examination (including baseline resting average high blood pressure \[average systolic blood pressure ≥140 mmhg or resting average diastolic blood pressure ≥90 mmhg or high random blood sugar \[nonfasting\]), clinically significant abnormal laboratory test results or positive test for hiv, hepatitis b, or hepatitis c found during medical screening. 2. any acute or chronic ongoing illness which, in the judgement of the investigator, may preclude the subject's participation. subjects who have a chronic condition that is stable and controlled and otherwise healthy should not be excluded. within at least the past 3 months must not have received another covid-19 vaccine. 3. persons who received another covid-19 vaccine within the past 3 months prior to dosing. 4. persons who received a primary vaccination series and or a booster vaccination dose of a non-mrna covid-19 vaccine (ie matrix m adjuvanted covid-19 vaccine, novavax). 5. persons who have a history of covid-19 or virologically confirmed sars-cov-2 infection in the past 3 months. 6. persons with a history of covid-19 with ongoing sequelae. 7. persons with a history of myocarditis and/or pericarditis. 8. positive pregnancy, urine drug screen, or alcohol breath test at screening. 9. known history of allergic reactions or hypersensitivity to any vaccine, or to any excipient in the formulation (including the adjuvants: mf59c.1 and matrix-m). 10. presence of a known, or suspected, impairment of the immune system including, but not limited to, hiv, autoimmune disorders, immunosuppressant therapy, and diabetes mellitus. 11. history of a known, or suspected, respiratory system disorder including, but not limited to, cystic fibrosis, reactive airway disease, emphysema, chronic bronchitis, chronic obstructive pulmonary disease (copd), or asthma, excluding childhood asthma. 12. history of significant alcohol abuse within 12 months prior to screening. 13. positive test for drugs of abuse (such as marijuana/ tetrahydrocannabinol \[thc\] products, amphetamine, methamphetamine, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine \[mdma\], or phencyclidine \[pcp\]) at screening, prior to dosing, or a history of drug abuse within 12months prior to screening. 14. participation in a clinical research study involving the administration of an investigational, or marketed, drug or device within 30 days prior to receiving the treatment administration, or administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving drug, vaccine, or device administration, or intent to participate in another clinical study at any time during the conduct of the study. 15. use of medications for the timeframes specified below, (except for hormonal contraceptives and medications exempted by the investigator on a case-by-case basis) because they are judged to interfere with subject safety e.g., topical drug products without significant systemic absorption are permissible: 1. a new, or a change in a prescription medication within 14 days prior to treatment administration; 2. any medication, or treatments, that may affect the immune system such as allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other drugs are known to be frequently associated with significant major organ toxicity within 90 days prior to enrolment; 3. any registered vaccine administered within 30 days prior to enrolment in the study, or who plan to receive any non-study vaccines within 28 days of the study vaccine 4. any other investigational coronavirus vaccine i.e. sars-cov-1, sars-cov-2, mers etc. at any time prior to, or during, the study. 5. over-the-counter products within 7 days prior to dosing, with the exception of the occasional use of paracetamol (up to 2 g daily) and standard dose vitamins. 16. donation of plasma within 7 days prior to dosing. donation or loss of blood (excluding volume drawn at screening) of 50 ml to 499 ml of blood within 30 days, or more than 499 ml within 56 days prior to dosing. 17. receipt of blood products within 2 months prior to vaccine administration (day 1), or planned receipt of blood products during the study period (screening through day 29). 18. breast-feeding subjects, or subjects who plan to breastfeed from the time of the vaccination through 60 days after the treatment administration. 19. presence of tattoos, scarring, skin discolouration, or any other skin disturbances at the injection site which, in the opinion of the investigator, may inhibit the ability to effectively perform an injection site assessment. 20. employee or immediate relative of an employee of the clinical site, any of its affiliates or partners, or syneos health. 21. employees of the specific team at the university of queensland responsible for manufacturing and managing the ip (investigational product) or their immediate relatives. 22. any reason that, in the opinion of the investigator, would interfere with the primary study objectives or prevent the subject from participating in the study.

subjects to whom any of the following applies will be excluded from the study: 1. any clinically significant abnormality or vital sign abnormality at physical examination (including baseline resting average high blood pressure \[average systolic blood pressure ≥140 mmhg or resting average diastolic blood pressure ≥90 mmhg or high random blood sugar \[nonfasting\]), clinically significant abnormal laboratory test results or positive test for hiv, hepatitis b, or hepatitis c found during medical screening. 2. any acute or chronic ongoing illness which, in the judgement of the investigator, may preclude the subject's participation. subjects who have a chronic condition that is stable and controlled and otherwise healthy should not be excluded. within at least the past 3 months must not have received another covid-19 vaccine. 3. persons who received another covid-19 vaccine within the past 3 months prior to dosing. 4. persons who received a primary vaccination series and or a booster vaccination dose of a non-mrna covid-19 vaccine (ie matrix m adjuvanted covid-19 vaccine, novavax). 5. persons who have a history of covid-19 or virologically confirmed sars-cov-2 infection in the past 3 months. 6. persons with a history of covid-19 with ongoing sequelae. 7. persons with a history of myocarditis and/or pericarditis. 8. positive pregnancy, urine drug screen, or alcohol breath test at screening. 9. known history of allergic reactions or hypersensitivity to any vaccine, or to any excipient in the formulation (including the adjuvants: mf59c.1 and matrix-m). 10. presence of a known, or suspected, impairment of the immune system including, but not limited to, hiv, autoimmune disorders, immunosuppressant therapy, and diabetes mellitus. 11. history of a known, or suspected, respiratory system disorder including, but not limited to, cystic fibrosis, reactive airway disease, emphysema, chronic bronchitis, chronic obstructive pulmonary disease (copd), or asthma, excluding childhood asthma. 12. history of significant alcohol abuse within 12 months prior to screening. 13. positive test for drugs of abuse (such as marijuana/ tetrahydrocannabinol \[thc\] products, amphetamine, methamphetamine, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine \[mdma\], or phencyclidine \[pcp\]) at screening, prior to dosing, or a history of drug abuse within 12months prior to screening. 14. participation in a clinical research study involving the administration of an investigational, or marketed, drug or device within 30 days prior to receiving the treatment administration, or administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving drug, vaccine, or device administration, or intent to participate in another clinical study at any time during the conduct of the study. 15. use of medications for the timeframes specified below, (except for hormonal contraceptives and medications exempted by the investigator on a case-by-case basis) because they are judged to interfere with subject safety e.g., topical drug products without significant systemic absorption are permissible: 1. a new, or a change in a prescription medication within 14 days prior to treatment administration; 2. any medication, or treatments, that may affect the immune system such as allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other drugs are known to be frequently associated with significant major organ toxicity within 90 days prior to enrolment; 3. any registered vaccine administered within 30 days prior to enrolment in the study, or who plan to receive any non-study vaccines within 28 days of the study vaccine 4. any other investigational coronavirus vaccine i.e. sars-cov-1, sars-cov-2, mers etc. at any time prior to, or during, the study. 5. over-the-counter products within 7 days prior to dosing, with the exception of the occasional use of paracetamol (up to 2 g daily) and standard dose vitamins. 16. donation of plasma within 7 days prior to dosing. donation or loss of blood (excluding volume drawn at screening) of 50 ml to 499 ml of blood within 30 days, or more than 499 ml within 56 days prior to dosing. 17. receipt of blood products within 2 months prior to vaccine administration (day 1), or planned receipt of blood products during the study period (screening through day 29). 18. breast-feeding subjects, or subjects who plan to breastfeed from the time of the vaccination through 60 days after the treatment administration. 19. presence of tattoos, scarring, skin discolouration, or any other skin disturbances at the injection site which, in the opinion of the investigator, may inhibit the ability to effectively perform an injection site assessment. 20. employee or immediate relative of an employee of the clinical site, any of its affiliates or partners, or syneos health. 21. employees of the specific team at the university of queensland responsible for manufacturing and managing the ip (investigational product) or their immediate relatives. 22. any reason that, in the opinion of the investigator, would interfere with the primary study objectives or prevent the subject from participating in the study.

March 21, 2023, 4 p.m. usa

subjects to whom any of the following applies will be excluded from the study: any clinically significant abnormality or vital sign abnormality at physical examination (including baseline resting average high blood pressure [average systolic blood pressure ≥140 mmhg or resting average diastolic blood pressure ≥90 mmhg or high random blood sugar [nonfasting]), clinically significant abnormal laboratory test results or positive test for hiv, hepatitis b, or hepatitis c found during medical screening. any acute or chronic ongoing illness which, in the judgement of the investigator, may preclude the subject's participation. subjects who have a chronic condition that is stable and controlled and otherwise healthy should not be excluded. within at least the past 3 months must not have received another covid-19 vaccine. persons who received another covid-19 vaccine within the past 3 months prior to dosing. persons who received a primary vaccination series and or a booster vaccination dose of a non-mrna covid-19 vaccine (ie matrix m adjuvanted covid-19 vaccine, novavax). persons who have a history of covid-19 or virologically confirmed sars-cov-2 infection in the past 3 months. persons with a history of covid-19 with ongoing sequelae. persons with a history of myocarditis and/or pericarditis. positive pregnancy, urine drug screen, or alcohol breath test at screening. known history of allergic reactions or hypersensitivity to any vaccine, or to any excipient in the formulation (including the adjuvants: mf59c.1 and matrix-m). presence of a known, or suspected, impairment of the immune system including, but not limited to, hiv, autoimmune disorders, immunosuppressant therapy, and diabetes mellitus. history of a known, or suspected, respiratory system disorder including, but not limited to, cystic fibrosis, reactive airway disease, emphysema, chronic bronchitis, chronic obstructive pulmonary disease (copd), or asthma, excluding childhood asthma. history of significant alcohol abuse within 12 months prior to screening. positive test for drugs of abuse (such as marijuana/ tetrahydrocannabinol [thc] products, amphetamine, methamphetamine, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine [mdma], or phencyclidine [pcp]) at screening, prior to dosing, or a history of drug abuse within 12months prior to screening. participation in a clinical research study involving the administration of an investigational, or marketed, drug or device within 30 days prior to receiving the treatment administration, or administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving drug, vaccine, or device administration, or intent to participate in another clinical study at any time during the conduct of the study. use of medications for the timeframes specified below, (except for hormonal contraceptives and medications exempted by the investigator on a case-by-case basis) because they are judged to interfere with subject safety e.g., topical drug products without significant systemic absorption are permissible: a new, or a change in a prescription medication within 14 days prior to treatment administration; any medication, or treatments, that may affect the immune system such as allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other drugs are known to be frequently associated with significant major organ toxicity within 90 days prior to enrolment; any registered vaccine administered within 30 days prior to enrolment in the study, or who plan to receive any non-study vaccines within 28 days of the study vaccine any other investigational coronavirus vaccine i.e. sars-cov-1, sars-cov-2, mers etc. at any time prior to, or during, the study. over-the-counter products within 7 days prior to dosing, with the exception of the occasional use of paracetamol (up to 2 g daily) and standard dose vitamins. donation of plasma within 7 days prior to dosing. donation or loss of blood (excluding volume drawn at screening) of 50 ml to 499 ml of blood within 30 days, or more than 499 ml within 56 days prior to dosing. receipt of blood products within 2 months prior to vaccine administration (day 1), or planned receipt of blood products during the study period (screening through day 29). breast-feeding subjects, or subjects who plan to breastfeed from the time of the vaccination through 60 days after the treatment administration. presence of tattoos, scarring, skin discolouration, or any other skin disturbances at the injection site which, in the opinion of the investigator, may inhibit the ability to effectively perform an injection site assessment. employee or immediate relative of an employee of the clinical site, any of its affiliates or partners, or syneos health. employees of the specific team at the university of queensland responsible for manufacturing and managing the ip (investigational product) or their immediate relatives. any reason that, in the opinion of the investigator, would interfere with the primary study objectives or prevent the subject from participating in the study.

subjects to whom any of the following applies will be excluded from the study: any clinically significant abnormality or vital sign abnormality at physical examination (including baseline resting average high blood pressure [average systolic blood pressure ≥140 mmhg or resting average diastolic blood pressure ≥90 mmhg or high random blood sugar [nonfasting]), clinically significant abnormal laboratory test results or positive test for hiv, hepatitis b, or hepatitis c found during medical screening. any acute or chronic ongoing illness which, in the judgement of the investigator, may preclude the subject's participation. subjects who have a chronic condition that is stable and controlled and otherwise healthy should not be excluded. within at least the past 3 months must not have received another covid-19 vaccine. persons who received another covid-19 vaccine within the past 3 months prior to dosing. persons who received a primary vaccination series and or a booster vaccination dose of a non-mrna covid-19 vaccine (ie matrix m adjuvanted covid-19 vaccine, novavax). persons who have a history of covid-19 or virologically confirmed sars-cov-2 infection in the past 3 months. persons with a history of covid-19 with ongoing sequelae. persons with a history of myocarditis and/or pericarditis. positive pregnancy, urine drug screen, or alcohol breath test at screening. known history of allergic reactions or hypersensitivity to any vaccine, or to any excipient in the formulation (including the adjuvants: mf59c.1 and matrix-m). presence of a known, or suspected, impairment of the immune system including, but not limited to, hiv, autoimmune disorders, immunosuppressant therapy, and diabetes mellitus. history of a known, or suspected, respiratory system disorder including, but not limited to, cystic fibrosis, reactive airway disease, emphysema, chronic bronchitis, chronic obstructive pulmonary disease (copd), or asthma, excluding childhood asthma. history of significant alcohol abuse within 12 months prior to screening. positive test for drugs of abuse (such as marijuana/ tetrahydrocannabinol [thc] products, amphetamine, methamphetamine, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine [mdma], or phencyclidine [pcp]) at screening, prior to dosing, or a history of drug abuse within 12months prior to screening. participation in a clinical research study involving the administration of an investigational, or marketed, drug or device within 30 days prior to receiving the treatment administration, or administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving drug, vaccine, or device administration, or intent to participate in another clinical study at any time during the conduct of the study. use of medications for the timeframes specified below, (except for hormonal contraceptives and medications exempted by the investigator on a case-by-case basis) because they are judged to interfere with subject safety e.g., topical drug products without significant systemic absorption are permissible: a new, or a change in a prescription medication within 14 days prior to treatment administration; any medication, or treatments, that may affect the immune system such as allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other drugs are known to be frequently associated with significant major organ toxicity within 90 days prior to enrolment; any registered vaccine administered within 30 days prior to enrolment in the study, or who plan to receive any non-study vaccines within 28 days of the study vaccine any other investigational coronavirus vaccine i.e. sars-cov-1, sars-cov-2, mers etc. at any time prior to, or during, the study. over-the-counter products within 7 days prior to dosing, with the exception of the occasional use of paracetamol (up to 2 g daily) and standard dose vitamins. donation of plasma within 7 days prior to dosing. donation or loss of blood (excluding volume drawn at screening) of 50 ml to 499 ml of blood within 30 days, or more than 499 ml within 56 days prior to dosing. receipt of blood products within 2 months prior to vaccine administration (day 1), or planned receipt of blood products during the study period (screening through day 29). breast-feeding subjects, or subjects who plan to breastfeed from the time of the vaccination through 60 days after the treatment administration. presence of tattoos, scarring, skin discolouration, or any other skin disturbances at the injection site which, in the opinion of the investigator, may inhibit the ability to effectively perform an injection site assessment. employee or immediate relative of an employee of the clinical site, any of its affiliates or partners, or syneos health. employees of the specific team at the university of queensland responsible for manufacturing and managing the ip (investigational product) or their immediate relatives. any reason that, in the opinion of the investigator, would interfere with the primary study objectives or prevent the subject from participating in the study.