Created at Source Raw Value Validated value
Feb. 25, 2022, noon oms

The following criteria should be checked at the time of study entry. If any of these apply at the time of study entry, the subject must not be included in the study: <br/ > 1. History of any of the following: <br/ > â?¢ Any investigational vaccine or a COVID vaccine that has got emergency use <br/ > authorization or <br/ > â?¢ Any product (investigational or off-label) for prevention of COVID-19 disease <br/ > â?¢ Inoculated with any subunit vaccine and inactivated vaccine within 14 days <br/ > before the first dose of study vaccination, <br/ > â?¢ Inoculated live attenuated vaccine within 30 days. <br/ > â?¢ Received influenza vaccination within 14 days prior to first study vaccination <br/ > 2. Have an acute or chronic illness, as determined by the site Principal Investigator (PI) or <br/ > sub-investigator, within 72 hours prior to study vaccination. <br/ > 3. Seropositive for HIV 1 and 2, HBsAg and HCV <br/ > 4. Have a history of severe allergies to any component of the research vaccine i.e. RLS <br/ > Protein Subunit Vaccine against SARS-CoV-2 Virus, including aluminum preparations, <br/ > such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, <br/ > thrombocytopenic purpura, local allergic necrosis (Arthus reaction), or any previous <br/ > History of serious side effects of vaccines or drugs, such as allergies, urticaria, skin <br/ > eczema, dyspnea, angioedema, etc . History of allergic disease or reactions likely to be <br/ > exacerbated by any component of the vaccines in study. <br/ > 5. Those with a history of SARS COVID-19 or current COVID-19 infection meeting any of <br/ > the following: <br/ > ï?? History of confirmed SARS-CoV 2 infection or symptomatic disease, <br/ > ï?? RTPCR test which is positive within 72 hours prior to enrollment. <br/ > ï?? Positive for SARS-CoV-2 IgG antibodies â?¥ 5 (Index value). <br/ > 6. Have taken antipyretics or analgesics within 24 hours before the first dose of vaccine. <br/ > 7. Suspected or known current alcohol abuse as defined by an alcohol intake of greater <br/ > than 42 units every week for at least one year, <br/ > 8. Chronic administration (defined as more than 14 days in total) of immunosuppressant <br/ > (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying <br/ > drugs (e.g. interferons) during the period starting six months prior to the first vaccine <br/ > dose including use of any blood products. For corticosteroids, this will mean prednisone <br/ > > 0.5 mg/kg/day, or its equivalent (Methylprednisolone 0.4 mg/kg/day, Betamethasone0.08 mg/kg/day, Dexamethasone 0.08 mg/kg/day). Inhaled and topical steroids are allowed, Subjects under immune suppression post-transplant. <br/ > 9. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on <br/ > medical history and physical examination (no laboratory testing required), <br/ > 10. Any medical condition that in the judgment of the investigator would make study <br/ > participation unsafe and/or can interfere with assessment or vaccine response. <br/ > 11. Have received blood or blood-related products, including immunoglobulin within 3 <br/ > months, or plan to use it during the study. <br/ > 12. Lactating women or pregnant women (as determined by serum beta HCG).

The following criteria should be checked at the time of study entry. If any of these apply at the time of study entry, the subject must not be included in the study: <br/ > 1. History of any of the following: <br/ > â?¢ Any investigational vaccine or a COVID vaccine that has got emergency use <br/ > authorization or <br/ > â?¢ Any product (investigational or off-label) for prevention of COVID-19 disease <br/ > â?¢ Inoculated with any subunit vaccine and inactivated vaccine within 14 days <br/ > before the first dose of study vaccination, <br/ > â?¢ Inoculated live attenuated vaccine within 30 days. <br/ > â?¢ Received influenza vaccination within 14 days prior to first study vaccination <br/ > 2. Have an acute or chronic illness, as determined by the site Principal Investigator (PI) or <br/ > sub-investigator, within 72 hours prior to study vaccination. <br/ > 3. Seropositive for HIV 1 and 2, HBsAg and HCV <br/ > 4. Have a history of severe allergies to any component of the research vaccine i.e. RLS <br/ > Protein Subunit Vaccine against SARS-CoV-2 Virus, including aluminum preparations, <br/ > such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, <br/ > thrombocytopenic purpura, local allergic necrosis (Arthus reaction), or any previous <br/ > History of serious side effects of vaccines or drugs, such as allergies, urticaria, skin <br/ > eczema, dyspnea, angioedema, etc . History of allergic disease or reactions likely to be <br/ > exacerbated by any component of the vaccines in study. <br/ > 5. Those with a history of SARS COVID-19 or current COVID-19 infection meeting any of <br/ > the following: <br/ > ï?? History of confirmed SARS-CoV 2 infection or symptomatic disease, <br/ > ï?? RTPCR test which is positive within 72 hours prior to enrollment. <br/ > ï?? Positive for SARS-CoV-2 IgG antibodies â?¥ 5 (Index value). <br/ > 6. Have taken antipyretics or analgesics within 24 hours before the first dose of vaccine. <br/ > 7. Suspected or known current alcohol abuse as defined by an alcohol intake of greater <br/ > than 42 units every week for at least one year, <br/ > 8. Chronic administration (defined as more than 14 days in total) of immunosuppressant <br/ > (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying <br/ > drugs (e.g. interferons) during the period starting six months prior to the first vaccine <br/ > dose including use of any blood products. For corticosteroids, this will mean prednisone <br/ > > 0.5 mg/kg/day, or its equivalent (Methylprednisolone 0.4 mg/kg/day, Betamethasone0.08 mg/kg/day, Dexamethasone 0.08 mg/kg/day). Inhaled and topical steroids are allowed, Subjects under immune suppression post-transplant. <br/ > 9. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on <br/ > medical history and physical examination (no laboratory testing required), <br/ > 10. Any medical condition that in the judgment of the investigator would make study <br/ > participation unsafe and/or can interfere with assessment or vaccine response. <br/ > 11. Have received blood or blood-related products, including immunoglobulin within 3 <br/ > months, or plan to use it during the study. <br/ > 12. Lactating women or pregnant women (as determined by serum beta HCG).