Created at Source Raw Value Validated value
June 30, 2022, 4:30 p.m. oms

1. Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within <br/ >4 weeks of enrolment <br/ >2. History or laboratory evidence of confirmed SARS-CoV-2 infection after primary <br/ >vaccination or RTPCR positive for COVID-19 at the time of screening <br/ >3. Subjects who have received one or two doses of any approved or experimental <br/ >COVID-19 vaccine other than Covaxin or Covishield in past. <br/ >4. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ >5. History of SARS/ MERS infection <br/ >6. Past history of hypersensitivity reaction or any serious adverse event after any <br/ >vaccination <br/ >7. Subjects with known history of thrombocytopenia or any coagulation disorder, or <br/ >subjects on anticoagulation therapy <br/ >8. Subjects with confirmed or suspected immunosuppressive or immunodeficiency <br/ >disorder, or subjects on any immunosuppressive or immunostimulant therapy <br/ >9. Clinically significant (uncontrolled) systemic disorder such as cardiovascular, <br/ >respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, <br/ >psychiatric or immunological disorder <br/ >10. Subjects administered blood, blood containing products or immunoglobulins within the <br/ >last 3 months or planned administration during the study <br/ >11. Any other vaccine administration within the last 30 days or planned to be administered <br/ >during 8 weeks after enrolment (upto day 56 of study) <br/ >12. Participation in another clinical trial in the past 3 months <br/ >13. Pregnant and lactating women <br/ >14. History of drug / alcohol abuse

1. Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within <br/ >4 weeks of enrolment <br/ >2. History or laboratory evidence of confirmed SARS-CoV-2 infection after primary <br/ >vaccination or RTPCR positive for COVID-19 at the time of screening <br/ >3. Subjects who have received one or two doses of any approved or experimental <br/ >COVID-19 vaccine other than Covaxin or Covishield in past. <br/ >4. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ >5. History of SARS/ MERS infection <br/ >6. Past history of hypersensitivity reaction or any serious adverse event after any <br/ >vaccination <br/ >7. Subjects with known history of thrombocytopenia or any coagulation disorder, or <br/ >subjects on anticoagulation therapy <br/ >8. Subjects with confirmed or suspected immunosuppressive or immunodeficiency <br/ >disorder, or subjects on any immunosuppressive or immunostimulant therapy <br/ >9. Clinically significant (uncontrolled) systemic disorder such as cardiovascular, <br/ >respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, <br/ >psychiatric or immunological disorder <br/ >10. Subjects administered blood, blood containing products or immunoglobulins within the <br/ >last 3 months or planned administration during the study <br/ >11. Any other vaccine administration within the last 30 days or planned to be administered <br/ >during 8 weeks after enrolment (upto day 56 of study) <br/ >12. Participation in another clinical trial in the past 3 months <br/ >13. Pregnant and lactating women <br/ >14. History of drug / alcohol abuse