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

1. pregnant or breastfeeding or have plan to become pregnant within 30 days after the last administration of the study intervention. 2. employees at the investigator's site, of the sponsor or delegate (e.g., contract research organization) who are directly involved in the conduct of the study. 3. currently receiving or received any investigational intervention within 30 days prior to the first dose of the study intervention. 4. administered any licensed live-attenuated vaccines within 28 days or other licensed non- live-attenuated vaccines within 7 days prior to the first dose of the study intervention. 5. administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of the study intervention. 6. currently receiving or anticipate receiving concomitant immunosuppressive or immune- modifying therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or \< 2 weeks of daily receipt of prednisone less than 20 mg or equivalent) within 12 weeks prior to the first dose of the study intervention. 7. currently receiving or anticipate receiving treatment with tumor necrosis factor (tnf)-α inhibitors, e.g., infliximab, adalimumab, etanercept within 12 weeks prior to the first dose of the study intervention. 8. major surgery or any radiation therapy within 12 weeks prior to the first dose of the study intervention. 9. has received any other investigational or approved covid-19 vaccine. 10. immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia. 11. a history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer (exceptions are squamous and basal cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the discretion of the investigator). 12. bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. 13. documented sars-cov-2 infection prior to the first dose of study intervention, or an individual with positive anti-sars-cov-2 antibody test at screening (including rapid tests). 14. a history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia, thrombosis with thrombocytopenia syndrome (tts), antiphospholipid syndrome, or capillary leak syndrome. 15. participant who, in the investigator's judgement, is not in a stable condition and by participating in the study could adversely affect the safety of the participant, interfere with adherence to study requirements or evaluation of any study endpoint. this may include a participant with ongoing acute diseases, severe infections, autoimmune disease, laboratory abnormality or serious medical conditions in the following systems: cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, or psychiatric. 16. a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the mvc-cov1901 or azd1222. 17. body (oral, rectal, or ear) temperature ≥ 38.0°c or acute illness (not including minor illnesses such as diarrhea or mild upper respiratory tract infection at the discretion of the investigator) within 2 days before the first dose of study intervention.

1. pregnant or breastfeeding or have plan to become pregnant within 30 days after the last administration of the study intervention. 2. employees at the investigator's site, of the sponsor or delegate (e.g., contract research organization) who are directly involved in the conduct of the study. 3. currently receiving or received any investigational intervention within 30 days prior to the first dose of the study intervention. 4. administered any licensed live-attenuated vaccines within 28 days or other licensed non- live-attenuated vaccines within 7 days prior to the first dose of the study intervention. 5. administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of the study intervention. 6. currently receiving or anticipate receiving concomitant immunosuppressive or immune- modifying therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or \< 2 weeks of daily receipt of prednisone less than 20 mg or equivalent) within 12 weeks prior to the first dose of the study intervention. 7. currently receiving or anticipate receiving treatment with tumor necrosis factor (tnf)-α inhibitors, e.g., infliximab, adalimumab, etanercept within 12 weeks prior to the first dose of the study intervention. 8. major surgery or any radiation therapy within 12 weeks prior to the first dose of the study intervention. 9. has received any other investigational or approved covid-19 vaccine. 10. immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia. 11. a history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer (exceptions are squamous and basal cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the discretion of the investigator). 12. bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. 13. documented sars-cov-2 infection prior to the first dose of study intervention, or an individual with positive anti-sars-cov-2 antibody test at screening (including rapid tests). 14. a history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia, thrombosis with thrombocytopenia syndrome (tts), antiphospholipid syndrome, or capillary leak syndrome. 15. participant who, in the investigator's judgement, is not in a stable condition and by participating in the study could adversely affect the safety of the participant, interfere with adherence to study requirements or evaluation of any study endpoint. this may include a participant with ongoing acute diseases, severe infections, autoimmune disease, laboratory abnormality or serious medical conditions in the following systems: cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, or psychiatric. 16. a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the mvc-cov1901 or azd1222. 17. body (oral, rectal, or ear) temperature ≥ 38.0°c or acute illness (not including minor illnesses such as diarrhea or mild upper respiratory tract infection at the discretion of the investigator) within 2 days before the first dose of study intervention.

Jan. 21, 2022, noon usa

pregnant or breastfeeding or have plan to become pregnant within 30 days after the last administration of the study intervention. employees at the investigator's site, of the sponsor or delegate (e.g., contract research organization) who are directly involved in the conduct of the study. currently receiving or received any investigational intervention within 30 days prior to the first dose of the study intervention. administered any licensed live-attenuated vaccines within 28 days or other licensed non- live-attenuated vaccines within 7 days prior to the first dose of the study intervention. administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of the study intervention. currently receiving or anticipate receiving concomitant immunosuppressive or immune- modifying therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone less than 20 mg or equivalent) within 12 weeks prior to the first dose of the study intervention. currently receiving or anticipate receiving treatment with tumor necrosis factor (tnf)-α inhibitors, e.g., infliximab, adalimumab, etanercept within 12 weeks prior to the first dose of the study intervention. major surgery or any radiation therapy within 12 weeks prior to the first dose of the study intervention. has received any other investigational or approved covid-19 vaccine. immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia. a history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer (exceptions are squamous and basal cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the discretion of the investigator). bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. documented sars-cov-2 infection prior to the first dose of study intervention, or an individual with positive anti-sars-cov-2 antibody test at screening (including rapid tests). a history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia, thrombosis with thrombocytopenia syndrome (tts), antiphospholipid syndrome, or capillary leak syndrome. participant who, in the investigator's judgement, is not in a stable condition and by participating in the study could adversely affect the safety of the participant, interfere with adherence to study requirements or evaluation of any study endpoint. this may include a participant with ongoing acute diseases, severe infections, autoimmune disease, laboratory abnormality or serious medical conditions in the following systems: cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, or psychiatric. a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the mvc-cov1901 or azd1222. body (oral, rectal, or ear) temperature ≥ 38.0°c or acute illness (not including minor illnesses such as diarrhea or mild upper respiratory tract infection at the discretion of the investigator) within 2 days before the first dose of study intervention.

pregnant or breastfeeding or have plan to become pregnant within 30 days after the last administration of the study intervention. employees at the investigator's site, of the sponsor or delegate (e.g., contract research organization) who are directly involved in the conduct of the study. currently receiving or received any investigational intervention within 30 days prior to the first dose of the study intervention. administered any licensed live-attenuated vaccines within 28 days or other licensed non- live-attenuated vaccines within 7 days prior to the first dose of the study intervention. administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of the study intervention. currently receiving or anticipate receiving concomitant immunosuppressive or immune- modifying therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone less than 20 mg or equivalent) within 12 weeks prior to the first dose of the study intervention. currently receiving or anticipate receiving treatment with tumor necrosis factor (tnf)-α inhibitors, e.g., infliximab, adalimumab, etanercept within 12 weeks prior to the first dose of the study intervention. major surgery or any radiation therapy within 12 weeks prior to the first dose of the study intervention. has received any other investigational or approved covid-19 vaccine. immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia. a history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer (exceptions are squamous and basal cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the discretion of the investigator). bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. documented sars-cov-2 infection prior to the first dose of study intervention, or an individual with positive anti-sars-cov-2 antibody test at screening (including rapid tests). a history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia, thrombosis with thrombocytopenia syndrome (tts), antiphospholipid syndrome, or capillary leak syndrome. participant who, in the investigator's judgement, is not in a stable condition and by participating in the study could adversely affect the safety of the participant, interfere with adherence to study requirements or evaluation of any study endpoint. this may include a participant with ongoing acute diseases, severe infections, autoimmune disease, laboratory abnormality or serious medical conditions in the following systems: cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, or psychiatric. a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the mvc-cov1901 or azd1222. body (oral, rectal, or ear) temperature ≥ 38.0°c or acute illness (not including minor illnesses such as diarrhea or mild upper respiratory tract infection at the discretion of the investigator) within 2 days before the first dose of study intervention.