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

inclusion criteria: * participant must sign an informed consent form (icf) indicating that he or she understands the purpose, procedures, and potential risks and benefits of the study, and is willing to participate in the study * all female participants of childbearing potential must have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration * participant must have a body mass index (bmi) less than or equal to (\<=) 30.0 kilograms per square meter (kg/m\^2) * applicable to cohorts 1 and 2 only: participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, clinical laboratory assessments, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (covid-19). applicable to cohort 3 only: in the investigator's clinical judgment, participant must be either in good or stable health participants may have underlying illnesses such as hyperlipoproteinemia or hypothyroidism, as long as their symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe covid-19 (participants may have medical conditions of mild severity (according to the toxicity grading scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, beta blockers, alpha blockers at the same effective dose).

inclusion criteria: * participant must sign an informed consent form (icf) indicating that he or she understands the purpose, procedures, and potential risks and benefits of the study, and is willing to participate in the study * all female participants of childbearing potential must have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration * participant must have a body mass index (bmi) less than or equal to (\<=) 30.0 kilograms per square meter (kg/m\^2) * applicable to cohorts 1 and 2 only: participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, clinical laboratory assessments, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (covid-19). applicable to cohort 3 only: in the investigator's clinical judgment, participant must be either in good or stable health participants may have underlying illnesses such as hyperlipoproteinemia or hypothyroidism, as long as their symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe covid-19 (participants may have medical conditions of mild severity (according to the toxicity grading scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, beta blockers, alpha blockers at the same effective dose).

July 1, 2022, 11 p.m. usa

inclusion criteria: participant must sign an informed consent form (icf) indicating that he or she understands the purpose, procedures, and potential risks and benefits of the study, and is willing to participate in the study all female participants of childbearing potential must have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration participant must have a body mass index (bmi) less than or equal to (<=) 30.0 kilograms per square meter (kg/m^2) applicable to cohorts 1 and 2 only: participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, clinical laboratory assessments, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (covid-19). applicable to cohort 3 only: in the investigator's clinical judgment, participant must be either in good or stable health participants may have underlying illnesses such as hyperlipoproteinemia or hypothyroidism, as long as their symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe covid-19 (participants may have medical conditions of mild severity (according to the toxicity grading scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, beta blockers, alpha blockers at the same effective dose).

inclusion criteria: participant must sign an informed consent form (icf) indicating that he or she understands the purpose, procedures, and potential risks and benefits of the study, and is willing to participate in the study all female participants of childbearing potential must have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration participant must have a body mass index (bmi) less than or equal to (<=) 30.0 kilograms per square meter (kg/m^2) applicable to cohorts 1 and 2 only: participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, clinical laboratory assessments, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (covid-19). applicable to cohort 3 only: in the investigator's clinical judgment, participant must be either in good or stable health participants may have underlying illnesses such as hyperlipoproteinemia or hypothyroidism, as long as their symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe covid-19 (participants may have medical conditions of mild severity (according to the toxicity grading scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, beta blockers, alpha blockers at the same effective dose).

June 9, 2022, 4 p.m. usa

None

None

Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria: - participant must sign an informed consent form (icf) indicating that he or she understands the purpose, procedures, and potential risks and benefits of the study, and is willing to participate in the study - all female participants of childbearing potential must have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration - participant must have a body mass index (bmi) less than or equal to (<=) 30.0 kilograms per square meter (kg/m^2) - applicable to cohorts 1 and 2 only: participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, clinical laboratory assessments, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (covid-19). applicable to cohort 3 only: in the investigator's clinical judgment, participant must be either in good or stable health participants may have underlying illnesses such as hyperlipoproteinemia or hypothyroidism, as long as their symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe covid-19 (participants may have medical conditions of mild severity (according to the toxicity grading scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, beta blockers, alpha blockers at the same effective dose).

inclusion criteria: - participant must sign an informed consent form (icf) indicating that he or she understands the purpose, procedures, and potential risks and benefits of the study, and is willing to participate in the study - all female participants of childbearing potential must have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration - participant must have a body mass index (bmi) less than or equal to (<=) 30.0 kilograms per square meter (kg/m^2) - applicable to cohorts 1 and 2 only: participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, clinical laboratory assessments, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (covid-19). applicable to cohort 3 only: in the investigator's clinical judgment, participant must be either in good or stable health participants may have underlying illnesses such as hyperlipoproteinemia or hypothyroidism, as long as their symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe covid-19 (participants may have medical conditions of mild severity (according to the toxicity grading scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, beta blockers, alpha blockers at the same effective dose).