Created at Source Raw Value Validated value
Feb. 8, 2023, 4:24 a.m. irct

Positive pregnancy test either at screening or just prior to intervention administration Female subject who is breastfeeding or plans to breastfeed from the time of intervention through 60 days after Has any medical disease or condition that, in the opinion of the principal investigator, precludes study participation Presence of self-reported or medically documented significant medical (including respiratory, cardiovascular, neurological, autoimmune, Immunodeficiency, and kidney diseases...) or psychiatric condition Has an acute illness within 2 weeks prior to injection, with or without fever [temperature ≥38.0°C], runny nose or eyes, shortness of breath, cough, weakness, and diarrhea, that in the opinion of the principal investigator, precludes study participation Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 or 2 antibodies Has participated in another investigational study involving any investigational product (study drug, biologic, or device) within 60 days, or 5 half-lives, whichever is longer, before intervention administration Currently enrolled in or plans to participate in another clinical trial during the study period Has previously participated in an investigational study involving lipid nanoparticles (LNPs) Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any components of the study product, any previous licensed or investigational vaccines or medication, and to any food or cosmetics History of using any medication that, in the opinion of the principal investigator or the study pharmacotherapist, may be associated with impaired immune responsiveness Anticipating the need for immunosuppressive treatment within Within 6 months after study enrollment Received immunoglobulins and/or any blood or blood products within the 4 months before intervention administration or the possible need to use at any time during the study Has any blood dyscrasias or significant disorder of coagulation Has any chronic liver disease, including fatty liver Has a history of alcohol abuse or other recreational drug use within 6 months before intervention administration Has a positive test result for drugs of abuse at screening Has any abnormality or permanent body art (e.g., tattoo) that would interfere with the ability to observe local reactions at the injection site (deltoid region) Received or plans to receive a licensed, live vaccine within 4 weeks before or after intervention administration Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after intervention administration History of clinical or virological diagnosis of COVID-19 within 3 months before intervention administration Positive SARS-CoV-2 or influenza PCR test from nasopharyngeal swab at the screening visit, with a maximum time interval of 48 hours between taking the test and intervention administration History of receiving medication to prevent COVID-19 within 3 months before intervention administration On current treatment with investigational agents for prophylaxis of COVID-19 Current use of any prescription or over-the-counter medications within 7 days prior to intervention administration, unless approved by the investigator or necessary to manage a chronic condition Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection Plan to travel outside Iran from enrollment through 28 days after intervention administration Reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care Non-ambulatory Recent (within the last 12 months) use of a dermal filler History of thrombosis Vulnerable groups and foreigners

Positive pregnancy test either at screening or just prior to intervention administration Female subject who is breastfeeding or plans to breastfeed from the time of intervention through 60 days after Has any medical disease or condition that, in the opinion of the principal investigator, precludes study participation Presence of self-reported or medically documented significant medical (including respiratory, cardiovascular, neurological, autoimmune, Immunodeficiency, and kidney diseases...) or psychiatric condition Has an acute illness within 2 weeks prior to injection, with or without fever [temperature ≥38.0°C], runny nose or eyes, shortness of breath, cough, weakness, and diarrhea, that in the opinion of the principal investigator, precludes study participation Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 or 2 antibodies Has participated in another investigational study involving any investigational product (study drug, biologic, or device) within 60 days, or 5 half-lives, whichever is longer, before intervention administration Currently enrolled in or plans to participate in another clinical trial during the study period Has previously participated in an investigational study involving lipid nanoparticles (LNPs) Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any components of the study product, any previous licensed or investigational vaccines or medication, and to any food or cosmetics History of using any medication that, in the opinion of the principal investigator or the study pharmacotherapist, may be associated with impaired immune responsiveness Anticipating the need for immunosuppressive treatment within Within 6 months after study enrollment Received immunoglobulins and/or any blood or blood products within the 4 months before intervention administration or the possible need to use at any time during the study Has any blood dyscrasias or significant disorder of coagulation Has any chronic liver disease, including fatty liver Has a history of alcohol abuse or other recreational drug use within 6 months before intervention administration Has a positive test result for drugs of abuse at screening Has any abnormality or permanent body art (e.g., tattoo) that would interfere with the ability to observe local reactions at the injection site (deltoid region) Received or plans to receive a licensed, live vaccine within 4 weeks before or after intervention administration Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after intervention administration History of clinical or virological diagnosis of COVID-19 within 3 months before intervention administration Positive SARS-CoV-2 or influenza PCR test from nasopharyngeal swab at the screening visit, with a maximum time interval of 48 hours between taking the test and intervention administration History of receiving medication to prevent COVID-19 within 3 months before intervention administration On current treatment with investigational agents for prophylaxis of COVID-19 Current use of any prescription or over-the-counter medications within 7 days prior to intervention administration, unless approved by the investigator or necessary to manage a chronic condition Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection Plan to travel outside Iran from enrollment through 28 days after intervention administration Reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care Non-ambulatory Recent (within the last 12 months) use of a dermal filler History of thrombosis Vulnerable groups and foreigners