Created at Source Raw Value Validated value
Aug. 5, 2021, 3:30 p.m. oms

1. Is age greater than equal to 18 and less than equal to 65 years on Study Day 1 2. Male and female healthy volunteers: 3. Judged by the investigator to be healthy on the basis of medical history, physical examination, vital signs, and no significant ECG abnormalities performed at screening 4. Able to provide informed consent form 5. Able and willing to comply with all study procedures over follow-up period of approximately 6 months 6. Body mass index of 18-32kg/square meter, inclusive, at screening 7. For female subjects with childbearing potential: must agree to avoid pregnancy from 21 days prior to study Day 1 until at least 90 days after last study vaccination. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm. 8. Men must be willing to refrain from sperm donation, starting after screening until 90 days after receiving the last study vaccination. Male and female subjects must use a barrier method of contraception, from 21 days prior to study Day 1 until at least 90 days after last study vaccination. Barrier methods of contraception include: • Male condoms • Female condoms • Female diaphragm (‘cap’)

1. Is age greater than equal to 18 and less than equal to 65 years on Study Day 1 2. Male and female healthy volunteers: 3. Judged by the investigator to be healthy on the basis of medical history, physical examination, vital signs, and no significant ECG abnormalities performed at screening 4. Able to provide informed consent form 5. Able and willing to comply with all study procedures over follow-up period of approximately 6 months 6. Body mass index of 18-32kg/square meter, inclusive, at screening 7. For female subjects with childbearing potential: must agree to avoid pregnancy from 21 days prior to study Day 1 until at least 90 days after last study vaccination. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm. 8. Men must be willing to refrain from sperm donation, starting after screening until 90 days after receiving the last study vaccination. Male and female subjects must use a barrier method of contraception, from 21 days prior to study Day 1 until at least 90 days after last study vaccination. Barrier methods of contraception include: • Male condoms • Female condoms • Female diaphragm (‘cap’)