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

1. any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (temperature \>38°c), or acute illness within 72 hours prior to the study vaccination (a prospective participant should not be included until 72 hours after the condition has resolved). 2. history of virologically-confirmed covid-19, sars or mers disease. 3. history of confirmed sars-cov-2 infection within three months before screening. 4. history of congenital or acquired immunodeficiency or autoimmune disease. 5. history of bleeding disorder including thrombocytopenia which is judged by the investigator as a contraindication for intramuscular vaccination. 6. history of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, guillain-barre syndrome) to any components of the study intervention. 7. history of malignancy within 1 year prior to the study vaccination (except for a participant judged by the investigator to have a low recurrence risk.) 8. any other clinically significant conditions such as uncontrollable chronic or acute diseases which, in the opinion of the investigator, might cause a health threat to the participant or interfere with the clinical trial procedures or interpretation of the study results. 9. any other conditions which might interfere with the evaluation of the study objectives (e.g. alcohol or drug abuse, neurologic or psychiatric conditions). 10. female participants who are pregnant or breastfeeding. 11. history of drug administration other than covid-19 vaccination intended to treat or prevent covid-19. 12. history or planned other vaccination within 4 weeks prior to the study vaccination through 28 days after the study vaccination (except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination). 13. receipt of immunoglobulins, whole blood or blood products within 12 weeks prior to the study vaccination. 14. use of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy for at least 2 consecutive weeks within 12 weeks prior to the study vaccination or long-term systemic corticosteroid therapy (e.g. ≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) (however, the use of topical and nasal glucocorticoids will be permitted.) 15. history of participation in another clinical study within 4 weeks prior to the study vaccination or planned participation in another clinical study during this study period. 16. investigators, study staff who are directly involved in the conduct of this study or supervised by the investigator, or their family members.

1. any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (temperature \>38°c), or acute illness within 72 hours prior to the study vaccination (a prospective participant should not be included until 72 hours after the condition has resolved). 2. history of virologically-confirmed covid-19, sars or mers disease. 3. history of confirmed sars-cov-2 infection within three months before screening. 4. history of congenital or acquired immunodeficiency or autoimmune disease. 5. history of bleeding disorder including thrombocytopenia which is judged by the investigator as a contraindication for intramuscular vaccination. 6. history of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, guillain-barre syndrome) to any components of the study intervention. 7. history of malignancy within 1 year prior to the study vaccination (except for a participant judged by the investigator to have a low recurrence risk.) 8. any other clinically significant conditions such as uncontrollable chronic or acute diseases which, in the opinion of the investigator, might cause a health threat to the participant or interfere with the clinical trial procedures or interpretation of the study results. 9. any other conditions which might interfere with the evaluation of the study objectives (e.g. alcohol or drug abuse, neurologic or psychiatric conditions). 10. female participants who are pregnant or breastfeeding. 11. history of drug administration other than covid-19 vaccination intended to treat or prevent covid-19. 12. history or planned other vaccination within 4 weeks prior to the study vaccination through 28 days after the study vaccination (except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination). 13. receipt of immunoglobulins, whole blood or blood products within 12 weeks prior to the study vaccination. 14. use of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy for at least 2 consecutive weeks within 12 weeks prior to the study vaccination or long-term systemic corticosteroid therapy (e.g. ≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) (however, the use of topical and nasal glucocorticoids will be permitted.) 15. history of participation in another clinical study within 4 weeks prior to the study vaccination or planned participation in another clinical study during this study period. 16. investigators, study staff who are directly involved in the conduct of this study or supervised by the investigator, or their family members.

Feb. 15, 2023, noon usa

any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (temperature >38°c), or acute illness within 72 hours prior to the study vaccination (a prospective participant should not be included until 72 hours after the condition has resolved). history of virologically-confirmed covid-19, sars or mers disease. history of confirmed sars-cov-2 infection within three months before screening. history of congenital or acquired immunodeficiency or autoimmune disease. history of bleeding disorder including thrombocytopenia which is judged by the investigator as a contraindication for intramuscular vaccination. history of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, guillain-barre syndrome) to any components of the study intervention. history of malignancy within 1 year prior to the study vaccination (except for a participant judged by the investigator to have a low recurrence risk.) any other clinically significant conditions such as uncontrollable chronic or acute diseases which, in the opinion of the investigator, might cause a health threat to the participant or interfere with the clinical trial procedures or interpretation of the study results. any other conditions which might interfere with the evaluation of the study objectives (e.g. alcohol or drug abuse, neurologic or psychiatric conditions). female participants who are pregnant or breastfeeding. history of drug administration other than covid-19 vaccination intended to treat or prevent covid-19. history or planned other vaccination within 4 weeks prior to the study vaccination through 28 days after the study vaccination (except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination). receipt of immunoglobulins, whole blood or blood products within 12 weeks prior to the study vaccination. use of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy for at least 2 consecutive weeks within 12 weeks prior to the study vaccination or long-term systemic corticosteroid therapy (e.g. ≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) (however, the use of topical and nasal glucocorticoids will be permitted.) history of participation in another clinical study within 4 weeks prior to the study vaccination or planned participation in another clinical study during this study period. investigators, study staff who are directly involved in the conduct of this study or supervised by the investigator, or their family members.

any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (temperature >38°c), or acute illness within 72 hours prior to the study vaccination (a prospective participant should not be included until 72 hours after the condition has resolved). history of virologically-confirmed covid-19, sars or mers disease. history of confirmed sars-cov-2 infection within three months before screening. history of congenital or acquired immunodeficiency or autoimmune disease. history of bleeding disorder including thrombocytopenia which is judged by the investigator as a contraindication for intramuscular vaccination. history of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, guillain-barre syndrome) to any components of the study intervention. history of malignancy within 1 year prior to the study vaccination (except for a participant judged by the investigator to have a low recurrence risk.) any other clinically significant conditions such as uncontrollable chronic or acute diseases which, in the opinion of the investigator, might cause a health threat to the participant or interfere with the clinical trial procedures or interpretation of the study results. any other conditions which might interfere with the evaluation of the study objectives (e.g. alcohol or drug abuse, neurologic or psychiatric conditions). female participants who are pregnant or breastfeeding. history of drug administration other than covid-19 vaccination intended to treat or prevent covid-19. history or planned other vaccination within 4 weeks prior to the study vaccination through 28 days after the study vaccination (except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination). receipt of immunoglobulins, whole blood or blood products within 12 weeks prior to the study vaccination. use of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy for at least 2 consecutive weeks within 12 weeks prior to the study vaccination or long-term systemic corticosteroid therapy (e.g. ≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) (however, the use of topical and nasal glucocorticoids will be permitted.) history of participation in another clinical study within 4 weeks prior to the study vaccination or planned participation in another clinical study during this study period. investigators, study staff who are directly involved in the conduct of this study or supervised by the investigator, or their family members.

Jan. 5, 2022, 7 a.m. usa

any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (temperature >38°c), or acute illness within 72 hours prior to the study vaccination (a prospective participant should not be included until 72 hours after the condition has resolved). history of virologically-confirmed covid-19, sars or mers disease. history of congenital or acquired immunodeficiency or autoimmune disease. history of bleeding disorder including thrombocytopenia which is judged by the investigator as a contraindication for intramuscular vaccination. history of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, guillain-barre syndrome) to any components of the study intervention. history of malignancy within 1 year prior to the study vaccination (except for a participant judged by the investigator to have a low recurrence risk.) any other clinically significant conditions such as uncontrollable chronic or acute diseases which, in the opinion of the investigator, might cause a health threat to the participant or interfere with the clinical trial procedures or interpretation of the study results. any other conditions which might interfere with the evaluation of the study objectives (e.g. alcohol or drug abuse, neurologic or psychiatric conditions). female participants who are pregnant or breastfeeding. history of drug administration other than covid-19 vaccination intended to treat or prevent covid-19. history or planned other vaccination within 4 weeks prior to the study vaccination through 28 days after the study vaccination (except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination). receipt of immunoglobulins, whole blood or blood products within 12 weeks prior to the study vaccination. use of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy for at least 2 consecutive weeks within 12 weeks prior to the study vaccination or long-term systemic corticosteroid therapy (e.g. ≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) (however, the use of topical and nasal glucocorticoids will be permitted.) history of participation in another clinical study within 4 weeks prior to the study vaccination or planned participation in another clinical study during this study period. investigators, study staff who are directly involved in the conduct of this study or supervised by the investigator, or their family members.

any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (temperature >38°c), or acute illness within 72 hours prior to the study vaccination (a prospective participant should not be included until 72 hours after the condition has resolved). history of virologically-confirmed covid-19, sars or mers disease. history of congenital or acquired immunodeficiency or autoimmune disease. history of bleeding disorder including thrombocytopenia which is judged by the investigator as a contraindication for intramuscular vaccination. history of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, guillain-barre syndrome) to any components of the study intervention. history of malignancy within 1 year prior to the study vaccination (except for a participant judged by the investigator to have a low recurrence risk.) any other clinically significant conditions such as uncontrollable chronic or acute diseases which, in the opinion of the investigator, might cause a health threat to the participant or interfere with the clinical trial procedures or interpretation of the study results. any other conditions which might interfere with the evaluation of the study objectives (e.g. alcohol or drug abuse, neurologic or psychiatric conditions). female participants who are pregnant or breastfeeding. history of drug administration other than covid-19 vaccination intended to treat or prevent covid-19. history or planned other vaccination within 4 weeks prior to the study vaccination through 28 days after the study vaccination (except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination). receipt of immunoglobulins, whole blood or blood products within 12 weeks prior to the study vaccination. use of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy for at least 2 consecutive weeks within 12 weeks prior to the study vaccination or long-term systemic corticosteroid therapy (e.g. ≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) (however, the use of topical and nasal glucocorticoids will be permitted.) history of participation in another clinical study within 4 weeks prior to the study vaccination or planned participation in another clinical study during this study period. investigators, study staff who are directly involved in the conduct of this study or supervised by the investigator, or their family members.