Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: for adults participant must have a body mass index (bmi) less than (<) 30.0 kilogram per meter square (kg/m^2) participant is 18 to 55 years of age, inclusive, or 65 years of age or older on the day of signing the informed consent form (icf). participant 18 to 55 years of age, inclusive: participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (covid-19), except for smoking and mild hypertension, which are allowed. participant 65 years of age and older: in the investigator's clinical judgment, participant must be either in good or stable health. participant may have underlying illnesses, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe covid-19, except for smoking and mild hypertension, which are allowed. if on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. participant will be included on the basis of physical examination, medical history, and vital signs participant will be included on the basis of physical examination, medical history, and vital signs all participants of childbearing potential must: a) have a negative highly sensitive urine pregnancy test at screening, b)have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study for adolescents: participant is 12 to 17 years of age, inclusive, on the day of signing the informed consent form (icf) participants must have signed an icf (or their legally acceptable representative or parent(s) [preferably both parents if available or as per local requirements] must sign) indicating that they understand the purpose of, and procedures required for, the study, are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures, and are willing (or the parents are willing for their adolescent) to participate in the study. informed assent must be obtained from adolescents, depending on local regulations and practice participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe covid-19

inclusion criteria: for adults participant must have a body mass index (bmi) less than (<) 30.0 kilogram per meter square (kg/m^2) participant is 18 to 55 years of age, inclusive, or 65 years of age or older on the day of signing the informed consent form (icf). participant 18 to 55 years of age, inclusive: participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (covid-19), except for smoking and mild hypertension, which are allowed. participant 65 years of age and older: in the investigator's clinical judgment, participant must be either in good or stable health. participant may have underlying illnesses, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe covid-19, except for smoking and mild hypertension, which are allowed. if on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. participant will be included on the basis of physical examination, medical history, and vital signs participant will be included on the basis of physical examination, medical history, and vital signs all participants of childbearing potential must: a) have a negative highly sensitive urine pregnancy test at screening, b)have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study for adolescents: participant is 12 to 17 years of age, inclusive, on the day of signing the informed consent form (icf) participants must have signed an icf (or their legally acceptable representative or parent(s) [preferably both parents if available or as per local requirements] must sign) indicating that they understand the purpose of, and procedures required for, the study, are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures, and are willing (or the parents are willing for their adolescent) to participate in the study. informed assent must be obtained from adolescents, depending on local regulations and practice participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe covid-19