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 (eg, anaphylaxis) to any component of the study vaccines. 2. known or suspected immunodeficiency. 3. bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 4. women who are pregnant or breastfeeding. 5. other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 6. immunosuppressants/radiotherapy: cohorts 1 and 2: receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study. cohorts 3 and 4: receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study. 7. blood/plasma products, immunoglobulin, or monoclonal antibodies: cohorts 1, 2, 3: receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study. cohort 4: receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for treatment/prevention of covid-19 or those considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study. 8. other study participation: cohorts 1 and 2: participation in other studies involving a study intervention within 28 days before randomization. anticipated participation in other studies within 28 days after receipt of study intervention in this study. cohorts 3 and 4: participation in other studies involving receipt of a study intervention within 28 days before randomization. anticipated participation in other studies involving a study intervention from randomization through the end of this study. 9. investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. 10. cohort 4 only: history of myocarditis or pericarditis

1. history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. 2. known or suspected immunodeficiency. 3. bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 4. women who are pregnant or breastfeeding. 5. other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 6. immunosuppressants/radiotherapy: cohorts 1 and 2: receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study. cohorts 3 and 4: receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study. 7. blood/plasma products, immunoglobulin, or monoclonal antibodies: cohorts 1, 2, 3: receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study. cohort 4: receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for treatment/prevention of covid-19 or those considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study. 8. other study participation: cohorts 1 and 2: participation in other studies involving a study intervention within 28 days before randomization. anticipated participation in other studies within 28 days after receipt of study intervention in this study. cohorts 3 and 4: participation in other studies involving receipt of a study intervention within 28 days before randomization. anticipated participation in other studies involving a study intervention from randomization through the end of this study. 9. investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. 10. cohort 4 only: history of myocarditis or pericarditis

Oct. 26, 2023, 4 a.m. usa

history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. known or suspected immunodeficiency. bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. women who are pregnant or breastfeeding. other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. immunosuppressants/radiotherapy: cohorts 1 and 2: receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study. cohorts 3 and 4: receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study. blood/plasma products, immunoglobulin, or monoclonal antibodies: cohorts 1, 2, 3: receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study. cohort 4: receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for treatment/prevention of covid-19 or those considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study. other study participation: cohorts 1 and 2: participation in other studies involving a study intervention within 28 days before randomization. anticipated participation in other studies within 28 days after receipt of study intervention in this study. cohorts 3 and 4: participation in other studies involving receipt of a study intervention within 28 days before randomization. anticipated participation in other studies involving a study intervention from randomization through the end of this study. investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. cohort 4 only: history of myocarditis or pericarditis

history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. known or suspected immunodeficiency. bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. women who are pregnant or breastfeeding. other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. immunosuppressants/radiotherapy: cohorts 1 and 2: receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study. cohorts 3 and 4: receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study. blood/plasma products, immunoglobulin, or monoclonal antibodies: cohorts 1, 2, 3: receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study. cohort 4: receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for treatment/prevention of covid-19 or those considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study. other study participation: cohorts 1 and 2: participation in other studies involving a study intervention within 28 days before randomization. anticipated participation in other studies within 28 days after receipt of study intervention in this study. cohorts 3 and 4: participation in other studies involving receipt of a study intervention within 28 days before randomization. anticipated participation in other studies involving a study intervention from randomization through the end of this study. investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. cohort 4 only: history of myocarditis or pericarditis

Oct. 4, 2022, 7 a.m. usa

all cohorts: history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. known or suspected immunodeficiency. bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. women who are pregnant or breastfeeding. other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study. investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. cohorts 1 and 2: receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study. participation in other studies involving a study intervention within 28 days before randomization. anticipated participation in other studies within 28 days after receipt of study intervention in this study. cohort 3: receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study. participation in other studies involving receipt of a study intervention within 28 days before randomization. anticipated participation in other studies involving a study intervention from randomization through the end of this study.

all cohorts: history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. known or suspected immunodeficiency. bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. women who are pregnant or breastfeeding. other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study. investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. cohorts 1 and 2: receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study. participation in other studies involving a study intervention within 28 days before randomization. anticipated participation in other studies within 28 days after receipt of study intervention in this study. cohort 3: receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study. participation in other studies involving receipt of a study intervention within 28 days before randomization. anticipated participation in other studies involving a study intervention from randomization through the end of this study.

Sept. 16, 2022, 2 a.m. usa

None

None

July 26, 2022, 2:30 p.m. usa

history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. known or suspected immunodeficiency. bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. women who are pregnant or breastfeeding. other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study. receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study. participation in other studies involving a study intervention within 28 days before randomization. anticipated participation in other studies within 28 days after receipt of study intervention in this study. investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. known or suspected immunodeficiency. bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. women who are pregnant or breastfeeding. other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study. receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study. participation in other studies involving a study intervention within 28 days before randomization. anticipated participation in other studies within 28 days after receipt of study intervention in this study. investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.