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

1. history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s). 2. previous clinical (based on covid-19 symptoms/signs alone, if a sars-cov-2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars-cov-2 naat result) diagnosis of covid-19 or positive antigen test for sars-cov-2 at baseline. 3. immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 4. has known or suspected allergy or history of anaphylaxis, urticaria, or other significant ar to the vaccine or its excipients. 5. bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 6. inability to observe possible local reactions at the injection sites due to a physical condition or permanent body art. 7. any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 8. pregnant or breastfeeding women. 9. individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 10. receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to covid-19, from 90 days before study intervention administration, or planned receipt throughout the study. 11. participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention.

1. history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s). 2. previous clinical (based on covid-19 symptoms/signs alone, if a sars-cov-2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars-cov-2 naat result) diagnosis of covid-19 or positive antigen test for sars-cov-2 at baseline. 3. immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 4. has known or suspected allergy or history of anaphylaxis, urticaria, or other significant ar to the vaccine or its excipients. 5. bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 6. inability to observe possible local reactions at the injection sites due to a physical condition or permanent body art. 7. any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 8. pregnant or breastfeeding women. 9. individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 10. receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to covid-19, from 90 days before study intervention administration, or planned receipt throughout the study. 11. participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention.

May 21, 2022, 9:30 a.m. usa

history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s). previous clinical (based on covid-19 symptoms/signs alone, if a sars-cov-2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars-cov-2 naat result) diagnosis of covid-19 or positive antigen test for sars-cov-2 at baseline. immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. has known or suspected allergy or history of anaphylaxis, urticaria, or other significant ar to the vaccine or its excipients. bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. inability to observe possible local reactions at the injection sites due to a physical condition or permanent body art. any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. pregnant or breastfeeding women. individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to covid-19, from 90 days before study intervention administration, or planned receipt throughout the study. participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention.

history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s). previous clinical (based on covid-19 symptoms/signs alone, if a sars-cov-2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars-cov-2 naat result) diagnosis of covid-19 or positive antigen test for sars-cov-2 at baseline. immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. has known or suspected allergy or history of anaphylaxis, urticaria, or other significant ar to the vaccine or its excipients. bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. inability to observe possible local reactions at the injection sites due to a physical condition or permanent body art. any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. pregnant or breastfeeding women. individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to covid-19, from 90 days before study intervention administration, or planned receipt throughout the study. participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention.