Created at Source Raw Value Validated value
Dec. 5, 2020, 12:45 a.m. oms

Participants are eligible for the study only if all of the following criteria are met: I01: Aged 18 years or older on the day of inclusion I02: A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile. OR • Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the second vaccination. A subject of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 4 hours before any dose of study intervention. I03: Informed consent form has been signed and dated I04: Able to attend all scheduled visits and to comply with all trial procedures I05: Covered by health insurance, only if required by local, regional or national regulations I06: SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies I07: For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on ARVs with CD4 count > 200/mm3

Participants are eligible for the study only if all of the following criteria are met: I01: Aged 18 years or older on the day of inclusion I02: A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile. OR • Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the second vaccination. A subject of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 4 hours before any dose of study intervention. I03: Informed consent form has been signed and dated I04: Able to attend all scheduled visits and to comply with all trial procedures I05: Covered by health insurance, only if required by local, regional or national regulations I06: SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies I07: For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on ARVs with CD4 count > 200/mm3