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

1. history of a systemic hypersensitivity or life-threatening reaction to a vaccine containing any of the same or similar substances. 2. history of test-confirmed by pcr or rapid antigen test to sars-cov-2 covid-19 infection within 3 months prior to randomisation. 3. presence of clinically significant medical history\*, unstable chronic or acute disease that, in the opinion of the pi, may increase the risk of exposure to the investigational vaccine 4. history of having any significant side effects after receipt of any other covid-19 vaccine eg. endocarditis, pericarditis or myocarditis. history of any severe reactogenic side effects or other medical illness that were thought to be associated with vaccine. 5. presence of an acute illness\* or with fever at 38.00 c or more within 72 hours prior to vaccination. 6. bleeding disorders or taking an anticoagulant or anti-platelet agent that may contraindicate for intramuscular injection based on investigator's judgment 7. inadequate venous access to allow the collection of blood samples. 8. received any prophylactic or therapeutic vaccine, biologic product, device or blood product, within 4 weeks of vaccination or 5 half-lives (whichever is longer) or anticipate doing so in the follow-up period defined for this study. for influenza vaccine, however, can be administered up to 14 days prior to randomization and following visit 3 (day 29+3) blood sample collection. 9. history of ever had an anaphylaxis reaction to food, medication, or vaccination. 10. participant is immunosuppressed as caused by disease or immunosuppressive therapy or anticipated need to use of any chemotherapy or immunosuppressive agents\* within the next 6 months. 11. participation in any of the other investigational trials of vaccines, therapeutic, or medical devices 12 weeks before or during the 6 months of this study. 12. received immunoglobulins and/or any blood or blood products within 3 months before vaccination day or plans to receive any blood or blood products at any time during the study.

1. history of a systemic hypersensitivity or life-threatening reaction to a vaccine containing any of the same or similar substances. 2. history of test-confirmed by pcr or rapid antigen test to sars-cov-2 covid-19 infection within 3 months prior to randomisation. 3. presence of clinically significant medical history\*, unstable chronic or acute disease that, in the opinion of the pi, may increase the risk of exposure to the investigational vaccine 4. history of having any significant side effects after receipt of any other covid-19 vaccine eg. endocarditis, pericarditis or myocarditis. history of any severe reactogenic side effects or other medical illness that were thought to be associated with vaccine. 5. presence of an acute illness\* or with fever at 38.00 c or more within 72 hours prior to vaccination. 6. bleeding disorders or taking an anticoagulant or anti-platelet agent that may contraindicate for intramuscular injection based on investigator's judgment 7. inadequate venous access to allow the collection of blood samples. 8. received any prophylactic or therapeutic vaccine, biologic product, device or blood product, within 4 weeks of vaccination or 5 half-lives (whichever is longer) or anticipate doing so in the follow-up period defined for this study. for influenza vaccine, however, can be administered up to 14 days prior to randomization and following visit 3 (day 29+3) blood sample collection. 9. history of ever had an anaphylaxis reaction to food, medication, or vaccination. 10. participant is immunosuppressed as caused by disease or immunosuppressive therapy or anticipated need to use of any chemotherapy or immunosuppressive agents\* within the next 6 months. 11. participation in any of the other investigational trials of vaccines, therapeutic, or medical devices 12 weeks before or during the 6 months of this study. 12. received immunoglobulins and/or any blood or blood products within 3 months before vaccination day or plans to receive any blood or blood products at any time during the study.

Oct. 12, 2023, 4 a.m. usa

history of a systemic hypersensitivity or life-threatening reaction to a vaccine containing any of the same or similar substances. history of test-confirmed by pcr or rapid antigen test to sars-cov-2 covid-19 infection within 3 months prior to randomisation. presence of clinically significant medical history*, unstable chronic or acute disease that, in the opinion of the pi, may increase the risk of exposure to the investigational vaccine history of having any significant side effects after receipt of any other covid-19 vaccine eg. endocarditis, pericarditis or myocarditis. history of any severe reactogenic side effects or other medical illness that were thought to be associated with vaccine. presence of an acute illness* or with fever at 38.00 c or more within 72 hours prior to vaccination. bleeding disorders or taking an anticoagulant or anti-platelet agent that may contraindicate for intramuscular injection based on investigator's judgment inadequate venous access to allow the collection of blood samples. received any prophylactic or therapeutic vaccine, biologic product, device or blood product, within 4 weeks of vaccination or 5 half-lives (whichever is longer) or anticipate doing so in the follow-up period defined for this study. for influenza vaccine, however, can be administered up to 14 days prior to randomization and following visit 3 (day 29+3) blood sample collection. history of ever had an anaphylaxis reaction to food, medication, or vaccination. participant is immunosuppressed as caused by disease or immunosuppressive therapy or anticipated need to use of any chemotherapy or immunosuppressive agents* within the next 6 months. participation in any of the other investigational trials of vaccines, therapeutic, or medical devices 12 weeks before or during the 6 months of this study. received immunoglobulins and/or any blood or blood products within 3 months before vaccination day or plans to receive any blood or blood products at any time during the study.

history of a systemic hypersensitivity or life-threatening reaction to a vaccine containing any of the same or similar substances. history of test-confirmed by pcr or rapid antigen test to sars-cov-2 covid-19 infection within 3 months prior to randomisation. presence of clinically significant medical history*, unstable chronic or acute disease that, in the opinion of the pi, may increase the risk of exposure to the investigational vaccine history of having any significant side effects after receipt of any other covid-19 vaccine eg. endocarditis, pericarditis or myocarditis. history of any severe reactogenic side effects or other medical illness that were thought to be associated with vaccine. presence of an acute illness* or with fever at 38.00 c or more within 72 hours prior to vaccination. bleeding disorders or taking an anticoagulant or anti-platelet agent that may contraindicate for intramuscular injection based on investigator's judgment inadequate venous access to allow the collection of blood samples. received any prophylactic or therapeutic vaccine, biologic product, device or blood product, within 4 weeks of vaccination or 5 half-lives (whichever is longer) or anticipate doing so in the follow-up period defined for this study. for influenza vaccine, however, can be administered up to 14 days prior to randomization and following visit 3 (day 29+3) blood sample collection. history of ever had an anaphylaxis reaction to food, medication, or vaccination. participant is immunosuppressed as caused by disease or immunosuppressive therapy or anticipated need to use of any chemotherapy or immunosuppressive agents* within the next 6 months. participation in any of the other investigational trials of vaccines, therapeutic, or medical devices 12 weeks before or during the 6 months of this study. received immunoglobulins and/or any blood or blood products within 3 months before vaccination day or plans to receive any blood or blood products at any time during the study.

Nov. 5, 2022, 8 a.m. usa

history of a systemic hypersensitivity or life-threatening reaction to a vaccine containing any of the same or similar substances. history of test-confirmed by pcr or rapid antigen test to sars-cov-2 covid-19 infection within 3 months prior to randomisation. presence of clinically significant medical history*, unstable chronic or acute disease that, in the opinion of the pi, may increase the risk of exposure to the investigational vaccine history of having any significant side effects after receipt of any other covid-19 vaccine eg. endocarditis, pericarditis or myocarditis. history of any severe reactogenic side effects or other medical illness that were thought to be associated with vaccine. presence of an acute illness* or with fever at 38.00 c or more within 72 hours prior to vaccination. bleeding disorders or taking an anticoagulant or anti-platelet agent that may contraindicate for intramuscular injection based on investigator's judgment inadequate venous access to allow the collection of blood samples. received any prophylactic or therapeutic vaccine, biologic product, device or blood product, within 4 weeks of vaccination or 5 half-lives (whichever is longer) or anticipate doing so in the follow-up period defined for this study. for influenza vaccine, however, can be administered up to 14 days prior to randomization. history of ever had an anaphylaxis reaction to food, medication, or vaccination. participant is immunosuppressed as caused by disease or immunosuppressive therapy or anticipated need to use of any chemotherapy or immunosuppressive agents* within the next 6 months. participation in any of the other investigational trials of vaccines, therapeutic, or medical devices 12 weeks before or during the 6 months of this study. received immunoglobulins and/or any blood or blood products within 3 months before vaccination day or plans to receive any blood or blood products at any time during the study.

history of a systemic hypersensitivity or life-threatening reaction to a vaccine containing any of the same or similar substances. history of test-confirmed by pcr or rapid antigen test to sars-cov-2 covid-19 infection within 3 months prior to randomisation. presence of clinically significant medical history*, unstable chronic or acute disease that, in the opinion of the pi, may increase the risk of exposure to the investigational vaccine history of having any significant side effects after receipt of any other covid-19 vaccine eg. endocarditis, pericarditis or myocarditis. history of any severe reactogenic side effects or other medical illness that were thought to be associated with vaccine. presence of an acute illness* or with fever at 38.00 c or more within 72 hours prior to vaccination. bleeding disorders or taking an anticoagulant or anti-platelet agent that may contraindicate for intramuscular injection based on investigator's judgment inadequate venous access to allow the collection of blood samples. received any prophylactic or therapeutic vaccine, biologic product, device or blood product, within 4 weeks of vaccination or 5 half-lives (whichever is longer) or anticipate doing so in the follow-up period defined for this study. for influenza vaccine, however, can be administered up to 14 days prior to randomization. history of ever had an anaphylaxis reaction to food, medication, or vaccination. participant is immunosuppressed as caused by disease or immunosuppressive therapy or anticipated need to use of any chemotherapy or immunosuppressive agents* within the next 6 months. participation in any of the other investigational trials of vaccines, therapeutic, or medical devices 12 weeks before or during the 6 months of this study. received immunoglobulins and/or any blood or blood products within 3 months before vaccination day or plans to receive any blood or blood products at any time during the study.