Created at Source Raw Value Validated value
Oct. 21, 2021, 10 a.m. oms

Subjects who meet any of the following exclusion criteria at the Screening visit (Visit 1) and/or 1st vaccination visit (Visit 2) will not be eligible for participation in this study. All Investigator assessment-based judgments must be carefully and fully documented in the source documents:1. According to the Investigator's opinion, significant acute or chronic, uncontrolled medical or neuropsychiatric illness.Acute disease is defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to the Screening visit (Visit 1) and/or 1st vaccination visit (Visit 2).'Uncontrolled' is defined as:- Requiring a new medical or surgical treatment during the three months prior to study vaccine administration, - Requiring any significant change in a chronic medication (i.e. drug, dose, frequency) during the three months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change meets the criteria outlined in inclusion criterion no. 8 and is appropriately justified by the Investigator.Investigator discretion is permitted with this exclusion criterion.2. Any confirmed or suspected current immunosuppressive condition or immunodeficiency, including cancer, HIV, hepatitis B or C infection (subjects with a history of cured hepatitis B or C infection without any signs of immunodeficiency at present time are allowed). Investigator discretion is permitted with this exclusion criterion,3. Current autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus or multiple sclerosis). Investigator discretion is permitted with this exclusion criterion. Subjects may be eligible to participate with appropriate written justification in the source document. For example, subjects with a history of autoimmune disease who are disease-free without treatment for three years or more, subjects receiving stable thyroid replacement therapy, and subjects with mild psoriasis (i.e. a small number of minor plaques requiring no systemic treatment) are eligible for participation,4. Administration of any medication or treatment that may alter the vaccine immune responses, such as:- Systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for 10 or more days in total, within one month prior to the 1st vaccination visit (Visit 2). Inhaled, nasal, ophthalmic, dermatological, and other topical glucocorticoids are permitted,- Cytotoxic, antineoplastic, or immunosuppressant drugs - within 36 months prior to 1st vaccination visit (Visit 2),- Any immunoglobulin preparations, blood products, or blood transfusion - within 6 months prior to 1st vaccination visit (Visit 2),5. Administration of any vaccine within 14 days prior to 1st vaccination visit (Visit 2), planned administration of any vaccine during the study (up to Day 28). Immunization on an emergency basis during the study will be evaluated on case-by-case basis by the Investigator,6. Administration of any other SARS-CoV-2/COVID-19 vaccine, or other experimental coronavirus vaccine at any time prior to or during the study,7. At screening (Visit 1), subjects found to be seropositive for prior SARS-COV-2 infection based on N-protein ELISA or positive for SARS-COV-2 PCR test,8. Subjects with previous diagnosis of COVID-19 or previous positive SARS-CoV-2 infection9. Use of any investigational or non-registered product

Subjects who meet any of the following exclusion criteria at the Screening visit (Visit 1) and/or 1st vaccination visit (Visit 2) will not be eligible for participation in this study. All Investigator assessment-based judgments must be carefully and fully documented in the source documents:1. According to the Investigator's opinion, significant acute or chronic, uncontrolled medical or neuropsychiatric illness.Acute disease is defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to the Screening visit (Visit 1) and/or 1st vaccination visit (Visit 2).'Uncontrolled' is defined as:- Requiring a new medical or surgical treatment during the three months prior to study vaccine administration, - Requiring any significant change in a chronic medication (i.e. drug, dose, frequency) during the three months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change meets the criteria outlined in inclusion criterion no. 8 and is appropriately justified by the Investigator.Investigator discretion is permitted with this exclusion criterion.2. Any confirmed or suspected current immunosuppressive condition or immunodeficiency, including cancer, HIV, hepatitis B or C infection (subjects with a history of cured hepatitis B or C infection without any signs of immunodeficiency at present time are allowed). Investigator discretion is permitted with this exclusion criterion,3. Current autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus or multiple sclerosis). Investigator discretion is permitted with this exclusion criterion. Subjects may be eligible to participate with appropriate written justification in the source document. For example, subjects with a history of autoimmune disease who are disease-free without treatment for three years or more, subjects receiving stable thyroid replacement therapy, and subjects with mild psoriasis (i.e. a small number of minor plaques requiring no systemic treatment) are eligible for participation,4. Administration of any medication or treatment that may alter the vaccine immune responses, such as:- Systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for 10 or more days in total, within one month prior to the 1st vaccination visit (Visit 2). Inhaled, nasal, ophthalmic, dermatological, and other topical glucocorticoids are permitted,- Cytotoxic, antineoplastic, or immunosuppressant drugs - within 36 months prior to 1st vaccination visit (Visit 2),- Any immunoglobulin preparations, blood products, or blood transfusion - within 6 months prior to 1st vaccination visit (Visit 2),5. Administration of any vaccine within 14 days prior to 1st vaccination visit (Visit 2), planned administration of any vaccine during the study (up to Day 28). Immunization on an emergency basis during the study will be evaluated on case-by-case basis by the Investigator,6. Administration of any other SARS-CoV-2/COVID-19 vaccine, or other experimental coronavirus vaccine at any time prior to or during the study,7. At screening (Visit 1), subjects found to be seropositive for prior SARS-COV-2 infection based on N-protein ELISA or positive for SARS-COV-2 PCR test,8. Subjects with previous diagnosis of COVID-19 or previous positive SARS-CoV-2 infection9. Use of any investigational or non-registered product