Created at Source Raw Value Validated value
April 6, 2022, 9 p.m. usa

None

None

Feb. 11, 2021, 12:31 a.m. usa

- female participant who is breastfeeding or intends to become pregnant from screening until at least 90 days after the 2nd vaccination. - history of any major (per investigator's discretion) cardiovascular, renal, neurological, metabolic, gastrointestinal, hepato-biliary, uncontrolled hypertension and diabetes, clinically significant chronic pulmonary disease, asthma (with the exception of history of resolved childhood asthma), immunological and autoimmune diseases or any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. - chronic use (more than 14 continuous days) of systemic corticosteroids within 30 days prior to screening. intra-articular, intra-bursal, or topical (skin or eyes) corticosteroids are permitted. - history of any haematological malignancy or active neoplastic disease (excluding non-melanoma skin cancer that was successfully treated). active is defined as having received treatment within the past 5 years. - history of demyelinating disease or guillain barre syndrome. - eczema or other significant skin lesion, infection or tattoo at the site of vaccination (left or right upper arm). - history of blood dyscrasia or significant disorder of coagulation that, in the opinion of the investigator, contraindicates im injection. - history of known or suspected hypersensitivity to kanamycin or any vaccine component, or any severe allergic reaction including anaphylaxis, generalized urticaria, angioedema, and other significant reaction. - presence of active viral or bacterial infection, with or without fever (tympanic temperature ≥38.0 °c) at screening or within 72 hours prior to each vaccination, if determined by the investigator to be of clinical significance (enrolment [provided screening period does not exceed 30 days] or dosing [see section 4.3.5.2] may be delayed for full recovery if acceptable to the investigator). - positive serological test for hepatitis b surface antigen (hbsag), hepatitis c antibody or hiv (type 1 or 2) antibody at screening. - known current or previous laboratory confirmed sars-cov-2 infection/covid-19, or positive for sars-cov-2 infection, either by sars-cov-2-specific igg antibody or rt-pcr, at screening. - suspected sars-cov-2 infection/covid-19, including individuals who are required to self-isolate. - individuals currently working in occupations with high risk of exposure to sarscov-2, e.g. healthcare workers in direct care of covid-19 patients, emergency responders or front-line workers. - receipt of any other sars-cov-2 or other experimental coronavirus vaccine at any time prior to the study or planned receipt of any other sars-cov-2 or other experimental vaccine within 57 days of receipt of the 1st study vaccination - participating in any other clinical study and have received any other investigational product (i.e. study vaccine, drug, biologic or device) within 30 days or 5 half-lives (whichever is longer) prior to screening, or are taking part in a non-medication study which, in the opinion of the investigator, would interfere with the interpretation of the assessments in this study - received or plans to receive a live-attenuated vaccine within 4 weeks before or after each study vaccination. - received or plans to receive an inactivated vaccine within 2 weeks before or after each study vaccination (including influenza vaccines). - received immunoglobulins and/or any blood or blood products within 3 months before the 1st vaccination or plans to receive any blood or blood products at any time during the study. - has a history of alcohol abuse, or other drug abuse assessed as a dependency problem by the investigator within 6 months before the 1st vaccination. - has any psychiatric or cognitive disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.

- female participant who is breastfeeding or intends to become pregnant from screening until at least 90 days after the 2nd vaccination. - history of any major (per investigator's discretion) cardiovascular, renal, neurological, metabolic, gastrointestinal, hepato-biliary, uncontrolled hypertension and diabetes, clinically significant chronic pulmonary disease, asthma (with the exception of history of resolved childhood asthma), immunological and autoimmune diseases or any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. - chronic use (more than 14 continuous days) of systemic corticosteroids within 30 days prior to screening. intra-articular, intra-bursal, or topical (skin or eyes) corticosteroids are permitted. - history of any haematological malignancy or active neoplastic disease (excluding non-melanoma skin cancer that was successfully treated). active is defined as having received treatment within the past 5 years. - history of demyelinating disease or guillain barre syndrome. - eczema or other significant skin lesion, infection or tattoo at the site of vaccination (left or right upper arm). - history of blood dyscrasia or significant disorder of coagulation that, in the opinion of the investigator, contraindicates im injection. - history of known or suspected hypersensitivity to kanamycin or any vaccine component, or any severe allergic reaction including anaphylaxis, generalized urticaria, angioedema, and other significant reaction. - presence of active viral or bacterial infection, with or without fever (tympanic temperature ≥38.0 °c) at screening or within 72 hours prior to each vaccination, if determined by the investigator to be of clinical significance (enrolment [provided screening period does not exceed 30 days] or dosing [see section 4.3.5.2] may be delayed for full recovery if acceptable to the investigator). - positive serological test for hepatitis b surface antigen (hbsag), hepatitis c antibody or hiv (type 1 or 2) antibody at screening. - known current or previous laboratory confirmed sars-cov-2 infection/covid-19, or positive for sars-cov-2 infection, either by sars-cov-2-specific igg antibody or rt-pcr, at screening. - suspected sars-cov-2 infection/covid-19, including individuals who are required to self-isolate. - individuals currently working in occupations with high risk of exposure to sarscov-2, e.g. healthcare workers in direct care of covid-19 patients, emergency responders or front-line workers. - receipt of any other sars-cov-2 or other experimental coronavirus vaccine at any time prior to the study or planned receipt of any other sars-cov-2 or other experimental vaccine within 57 days of receipt of the 1st study vaccination - participating in any other clinical study and have received any other investigational product (i.e. study vaccine, drug, biologic or device) within 30 days or 5 half-lives (whichever is longer) prior to screening, or are taking part in a non-medication study which, in the opinion of the investigator, would interfere with the interpretation of the assessments in this study - received or plans to receive a live-attenuated vaccine within 4 weeks before or after each study vaccination. - received or plans to receive an inactivated vaccine within 2 weeks before or after each study vaccination (including influenza vaccines). - received immunoglobulins and/or any blood or blood products within 3 months before the 1st vaccination or plans to receive any blood or blood products at any time during the study. - has a history of alcohol abuse, or other drug abuse assessed as a dependency problem by the investigator within 6 months before the 1st vaccination. - has any psychiatric or cognitive disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.