Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

Exclusion Criteria for Phase I: <br/ >1. Subject with a medical history of COVID-19 infection or who has received vaccine to prevent COVID-19 infection. <br/ >2. Subjects with a BMI > 30 kg/m2 <br/ >3. Protocol defined laboratory assessments outside the range/limit defined in Appendix 2. Any other laboratory value if â?¥ Grade 2 as per DAIDs criteria. <br/ >Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected version 2.1, July 2017, of the US National Institutes of Health <br/ >4. Any illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints. <br/ >5. Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g. healthcare worker in direct care of COVID-19 patients, front line workers in COVID 19 hotspots / outbreak areas). <br/ >6. History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine. <br/ >7. Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature â?¥38°C or â?¥100.4 °F) within 48 hours prior to vaccination. <br/ >8. History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease. <br/ >9. Subject has uncontrolled chronic disease including asthma, diabetes (HbA1c of >9%), hypertension (Systolic Blood pressure of >160 mm of Hg and/ or Diastolic Blood Pressure of >100 mm of Hg), thyroid disorder as assessed by the Investigator. <br/ >10. Subjects who are pregnant or breast feeding or willingness/intention to become pregnant during the study. <br/ >11. Prior major surgery or any radiation therapy within 4 weeks of Screening visit. <br/ >12. Positive serologic test for HIV 1 and 2, HBsAg or HCV. <br/ >13. Current (within 14 days prior to Screening visit) or anticipated concomitant immune modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day). <br/ >14. Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination. <br/ >15. Eczema or other significant skin lesion or infection at the site of vaccination. <br/ >16. Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit. <br/ >17. Bleeding diathesis or condition associated with prolonged bleeding. <br/ >18. Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate. <br/ >19. Any other condition which in the opinion of the Investigator may affect subjectâ??s safety or participation. <br/ > <br/ >Exclusion Criteria for Phase II: <br/ >1. Subject with a medical history of COVID-19 infection or who has received vaccine to prevent COVID-19 infection. <br/ >2. Any clinically significant laboratory values or illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiov

Exclusion Criteria for Phase I: <br/ >1. Subject with a medical history of COVID-19 infection or who has received vaccine to prevent COVID-19 infection. <br/ >2. Subjects with a BMI > 30 kg/m2 <br/ >3. Protocol defined laboratory assessments outside the range/limit defined in Appendix 2. Any other laboratory value if â?¥ Grade 2 as per DAIDs criteria. <br/ >Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected version 2.1, July 2017, of the US National Institutes of Health <br/ >4. Any illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints. <br/ >5. Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g. healthcare worker in direct care of COVID-19 patients, front line workers in COVID 19 hotspots / outbreak areas). <br/ >6. History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine. <br/ >7. Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature â?¥38°C or â?¥100.4 °F) within 48 hours prior to vaccination. <br/ >8. History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease. <br/ >9. Subject has uncontrolled chronic disease including asthma, diabetes (HbA1c of >9%), hypertension (Systolic Blood pressure of >160 mm of Hg and/ or Diastolic Blood Pressure of >100 mm of Hg), thyroid disorder as assessed by the Investigator. <br/ >10. Subjects who are pregnant or breast feeding or willingness/intention to become pregnant during the study. <br/ >11. Prior major surgery or any radiation therapy within 4 weeks of Screening visit. <br/ >12. Positive serologic test for HIV 1 and 2, HBsAg or HCV. <br/ >13. Current (within 14 days prior to Screening visit) or anticipated concomitant immune modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day). <br/ >14. Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination. <br/ >15. Eczema or other significant skin lesion or infection at the site of vaccination. <br/ >16. Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit. <br/ >17. Bleeding diathesis or condition associated with prolonged bleeding. <br/ >18. Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate. <br/ >19. Any other condition which in the opinion of the Investigator may affect subjectâ??s safety or participation. <br/ > <br/ >Exclusion Criteria for Phase II: <br/ >1. Subject with a medical history of COVID-19 infection or who has received vaccine to prevent COVID-19 infection. <br/ >2. Any clinically significant laboratory values or illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiov

Nov. 13, 2021, 5:33 p.m. oms

N/A

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May 27, 2021, 12:45 a.m. oms

Exclusion Criteria for Phase I: <br/ >1. Subject with a medical history of COVID-19 infection or who has received vaccine to prevent COVID-19 infection. <br/ >2. Subjects with a BMI > 30 kg/m2 <br/ >3. Protocol defined laboratory assessments outside the range/limit defined in Appendix 2. Any other laboratory value if â?¥ Grade 2 as per DAIDs criteria. <br/ >Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected version 2.1, July 2017, of the US National Institutes of Health <br/ >4. Any illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints. <br/ >5. Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g. healthcare worker in direct care of COVID-19 patients, front line workers in COVID 19 hotspots / outbreak areas). <br/ >6. History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine. <br/ >7. Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature â?¥38°C or â?¥100.4 °F) within 48 hours prior to vaccination. <br/ >8. History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease. <br/ >9. Subject has uncontrolled chronic disease including asthma, diabetes (HbA1c of >9%), hypertension (Systolic Blood pressure of >160 mm of Hg and/ or Diastolic Blood Pressure of >100 mm of Hg), thyroid disorder as assessed by the Investigator. <br/ >10. Subjects who are pregnant or breast feeding or willingness/intention to become pregnant during the study. <br/ >11. Prior major surgery or any radiation therapy within 4 weeks of Screening visit. <br/ >12. Positive serologic test for HIV 1 and 2, HBsAg or HCV. <br/ >13. Current (within 14 days prior to Screening visit) or anticipated concomitant immune modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day). <br/ >14. Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination. <br/ >15. Eczema or other significant skin lesion or infection at the site of vaccination. <br/ >16. Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit. <br/ >17. Bleeding diathesis or condition associated with prolonged bleeding. <br/ >18. Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate. <br/ >19. Any other condition which in the opinion of the Investigator may affect subjectâ??s safety or participation. <br/ > <br/ >Exclusion Criteria for Phase II: <br/ >1. Subject with a medical history of COVID-19 infection or who has received vaccine to prevent COVID-19 infection. <br/ >2. Any clinically significant laboratory values or illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiov

Exclusion Criteria for Phase I: <br/ >1. Subject with a medical history of COVID-19 infection or who has received vaccine to prevent COVID-19 infection. <br/ >2. Subjects with a BMI > 30 kg/m2 <br/ >3. Protocol defined laboratory assessments outside the range/limit defined in Appendix 2. Any other laboratory value if â?¥ Grade 2 as per DAIDs criteria. <br/ >Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected version 2.1, July 2017, of the US National Institutes of Health <br/ >4. Any illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints. <br/ >5. Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g. healthcare worker in direct care of COVID-19 patients, front line workers in COVID 19 hotspots / outbreak areas). <br/ >6. History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine. <br/ >7. Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature â?¥38°C or â?¥100.4 °F) within 48 hours prior to vaccination. <br/ >8. History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease. <br/ >9. Subject has uncontrolled chronic disease including asthma, diabetes (HbA1c of >9%), hypertension (Systolic Blood pressure of >160 mm of Hg and/ or Diastolic Blood Pressure of >100 mm of Hg), thyroid disorder as assessed by the Investigator. <br/ >10. Subjects who are pregnant or breast feeding or willingness/intention to become pregnant during the study. <br/ >11. Prior major surgery or any radiation therapy within 4 weeks of Screening visit. <br/ >12. Positive serologic test for HIV 1 and 2, HBsAg or HCV. <br/ >13. Current (within 14 days prior to Screening visit) or anticipated concomitant immune modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day). <br/ >14. Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination. <br/ >15. Eczema or other significant skin lesion or infection at the site of vaccination. <br/ >16. Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit. <br/ >17. Bleeding diathesis or condition associated with prolonged bleeding. <br/ >18. Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate. <br/ >19. Any other condition which in the opinion of the Investigator may affect subjectâ??s safety or participation. <br/ > <br/ >Exclusion Criteria for Phase II: <br/ >1. Subject with a medical history of COVID-19 infection or who has received vaccine to prevent COVID-19 infection. <br/ >2. Any clinically significant laboratory values or illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiov