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

* any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (tympanic 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. * concurrent or past sars-cov-2 infection within 12 weeks prior to the study vaccination confirmed by virological or serological testing * history of virologically or serologically confirmed sars, or mers disease * history of congenital, hereditary, acquired immunodeficiency, or autoimmune disease. * history of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion. * history of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, guillain-barre syndrome) to any vaccines or components of the study intervention. * history of malignancy within 1 year prior to the study vaccination (with the exception of malignancy with minimal risk of recurrence at the discretion of the investigator). * significant unstable chronic or acute illness that, in the opinion of the investigator, might pose a health risk to the participant if enrolled, or could interfere with the protocol-specified activities, or interpretation of study results. * any other conditions which, in the opinion of the investigator, 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. * receipt of any medications or vaccinations intended to prevent covid-19 except for the pre-defined covid-19 vaccines expected to be given prior to screening (mrna-1273, chadox1 ncov-19, ad26.cov2.s, bnt162b2, bbibp-corv, coronavac). * receipt of any vaccine within 4 weeks prior to the study vaccination or planned receipt of any vaccine from enrollment through 4 weeks after the study vaccination, except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination. * receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to the study vaccination. * chronic use (more than 2 consecutive weeks) of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) within 12 weeks prior to the study vaccination. the use of topical and nasal glucocorticoids will be permitted. * participation in another clinical study and receipt of study intervention within 4 weeks prior to the study vaccination, or concurrent, planned participation in another clinical study with study intervention during the study period. * investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members. * donation of ≥450ml of blood product within 4 weeks prior to screening, or planned donation of blood product during the study period

* any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (tympanic 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. * concurrent or past sars-cov-2 infection within 12 weeks prior to the study vaccination confirmed by virological or serological testing * history of virologically or serologically confirmed sars, or mers disease * history of congenital, hereditary, acquired immunodeficiency, or autoimmune disease. * history of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion. * history of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, guillain-barre syndrome) to any vaccines or components of the study intervention. * history of malignancy within 1 year prior to the study vaccination (with the exception of malignancy with minimal risk of recurrence at the discretion of the investigator). * significant unstable chronic or acute illness that, in the opinion of the investigator, might pose a health risk to the participant if enrolled, or could interfere with the protocol-specified activities, or interpretation of study results. * any other conditions which, in the opinion of the investigator, 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. * receipt of any medications or vaccinations intended to prevent covid-19 except for the pre-defined covid-19 vaccines expected to be given prior to screening (mrna-1273, chadox1 ncov-19, ad26.cov2.s, bnt162b2, bbibp-corv, coronavac). * receipt of any vaccine within 4 weeks prior to the study vaccination or planned receipt of any vaccine from enrollment through 4 weeks after the study vaccination, except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination. * receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to the study vaccination. * chronic use (more than 2 consecutive weeks) of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) within 12 weeks prior to the study vaccination. the use of topical and nasal glucocorticoids will be permitted. * participation in another clinical study and receipt of study intervention within 4 weeks prior to the study vaccination, or concurrent, planned participation in another clinical study with study intervention during the study period. * investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members. * donation of ≥450ml of blood product within 4 weeks prior to screening, or planned donation of blood product during the study period

April 20, 2023, 4 p.m. usa

any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (tympanic 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. concurrent or past sars-cov-2 infection within 12 weeks prior to the study vaccination confirmed by virological or serological testing history of virologically or serologically confirmed sars, or mers disease history of congenital, hereditary, acquired immunodeficiency, or autoimmune disease. history of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion. history of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, guillain-barre syndrome) to any vaccines or components of the study intervention. history of malignancy within 1 year prior to the study vaccination (with the exception of malignancy with minimal risk of recurrence at the discretion of the investigator). significant unstable chronic or acute illness that, in the opinion of the investigator, might pose a health risk to the participant if enrolled, or could interfere with the protocol-specified activities, or interpretation of study results. any other conditions which, in the opinion of the investigator, 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. receipt of any medications or vaccinations intended to prevent covid-19 except for the pre-defined covid-19 vaccines expected to be given prior to screening (mrna-1273, chadox1 ncov-19, ad26.cov2.s, bnt162b2, bbibp-corv, coronavac). receipt of any vaccine within 4 weeks prior to the study vaccination or planned receipt of any vaccine from enrollment through 4 weeks after the study vaccination, except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination. receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to the study vaccination. chronic use (more than 2 consecutive weeks) of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) within 12 weeks prior to the study vaccination. the use of topical and nasal glucocorticoids will be permitted. participation in another clinical study and receipt of study intervention within 4 weeks prior to the study vaccination, or concurrent, planned participation in another clinical study with study intervention during the study period. investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members. donation of ≥450ml of blood product within 4 weeks prior to screening, or planned donation of blood product during the study period

any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (tympanic 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. concurrent or past sars-cov-2 infection within 12 weeks prior to the study vaccination confirmed by virological or serological testing history of virologically or serologically confirmed sars, or mers disease history of congenital, hereditary, acquired immunodeficiency, or autoimmune disease. history of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion. history of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, guillain-barre syndrome) to any vaccines or components of the study intervention. history of malignancy within 1 year prior to the study vaccination (with the exception of malignancy with minimal risk of recurrence at the discretion of the investigator). significant unstable chronic or acute illness that, in the opinion of the investigator, might pose a health risk to the participant if enrolled, or could interfere with the protocol-specified activities, or interpretation of study results. any other conditions which, in the opinion of the investigator, 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. receipt of any medications or vaccinations intended to prevent covid-19 except for the pre-defined covid-19 vaccines expected to be given prior to screening (mrna-1273, chadox1 ncov-19, ad26.cov2.s, bnt162b2, bbibp-corv, coronavac). receipt of any vaccine within 4 weeks prior to the study vaccination or planned receipt of any vaccine from enrollment through 4 weeks after the study vaccination, except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination. receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to the study vaccination. chronic use (more than 2 consecutive weeks) of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) within 12 weeks prior to the study vaccination. the use of topical and nasal glucocorticoids will be permitted. participation in another clinical study and receipt of study intervention within 4 weeks prior to the study vaccination, or concurrent, planned participation in another clinical study with study intervention during the study period. investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members. donation of ≥450ml of blood product within 4 weeks prior to screening, or planned donation of blood product during the study period

Aug. 16, 2022, 6:30 p.m. usa

any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (tympanic 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. concurrent sars-cov-2 infection confirmed by virological or serological testing history of virologically or serologically confirmed sars, or mers disease history of congenital, hereditary, acquired immunodeficiency, or autoimmune disease. history of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion. history of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, guillain-barre syndrome) to any vaccines or components of the study intervention. history of malignancy within 1 year prior to the study vaccination (with the exception of malignancy with minimal risk of recurrence at the discretion of the investigator). significant unstable chronic or acute illness that, in the opinion of the investigator, might pose a health risk to the participant if enrolled, or could interfere with the protocol-specified activities, or interpretation of study results. any other conditions which, in the opinion of the investigator, 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. receipt of any medications or vaccinations intended to prevent covid-19 except for the pre-defined covid-19 vaccines expected to be given prior to screening (mrna-1273, chadox1 ncov-19, ad26.cov2.s, bnt162b2, bbibp-corv, coronavac). receipt of any vaccine within 4 weeks prior to the study vaccination or planned receipt of any vaccine from enrollment through 4 weeks after the study vaccination, except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination. receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to the study vaccination. chronic use (more than 2 consecutive weeks) of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) within 12 weeks prior to the study vaccination. the use of topical and nasal glucocorticoids will be permitted.

any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (tympanic 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. concurrent sars-cov-2 infection confirmed by virological or serological testing history of virologically or serologically confirmed sars, or mers disease history of congenital, hereditary, acquired immunodeficiency, or autoimmune disease. history of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion. history of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, guillain-barre syndrome) to any vaccines or components of the study intervention. history of malignancy within 1 year prior to the study vaccination (with the exception of malignancy with minimal risk of recurrence at the discretion of the investigator). significant unstable chronic or acute illness that, in the opinion of the investigator, might pose a health risk to the participant if enrolled, or could interfere with the protocol-specified activities, or interpretation of study results. any other conditions which, in the opinion of the investigator, 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. receipt of any medications or vaccinations intended to prevent covid-19 except for the pre-defined covid-19 vaccines expected to be given prior to screening (mrna-1273, chadox1 ncov-19, ad26.cov2.s, bnt162b2, bbibp-corv, coronavac). receipt of any vaccine within 4 weeks prior to the study vaccination or planned receipt of any vaccine from enrollment through 4 weeks after the study vaccination, except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination. receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to the study vaccination. chronic use (more than 2 consecutive weeks) of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) within 12 weeks prior to the study vaccination. the use of topical and nasal glucocorticoids will be permitted.