Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

Subjects will be enrolled in this trial only if they meet all of the following criteria: 1. Healthy male and female subjects &#8805,18 years of age. A healthy subject is defined as an individual who is in good general health, according to the Investigator’s assessment. Chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the Investigator. 2. Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. 3. Physical examination without clinically significant findings according to the Investigator’s assessment. 4. Body mass index (BMI) &#8805,18.0 and &#8804,30.0 kg/m2. 5. Female subjects of childbearing potential: at the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (required if serum pregnancy test was performed more than 3 days before). Additional information, please see the study protocol

Subjects will be enrolled in this trial only if they meet all of the following criteria: 1. Healthy male and female subjects &#8805,18 years of age. A healthy subject is defined as an individual who is in good general health, according to the Investigator’s assessment. Chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the Investigator. 2. Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. 3. Physical examination without clinically significant findings according to the Investigator’s assessment. 4. Body mass index (BMI) &#8805,18.0 and &#8804,30.0 kg/m2. 5. Female subjects of childbearing potential: at the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (required if serum pregnancy test was performed more than 3 days before). Additional information, please see the study protocol