Created at Source Raw Value Validated value
Aug. 17, 2021, 6 p.m. usa

- pregnant or lactating or intending to become pregnant or plans to breastfeed during the study. - positive pregnancy test at screening or prior to each vaccination. - any medical disease (acute, subacute, intermittent or chronic) or condition that in the opinion of the investigator compromise the volunteer's safety, preclude vaccination or compromise interpretation of the results. - history of serious psychiatric condition likely to affect participation in the study (e-g- ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication). - history of respiratory disease (e.g., chronic obstructive pulmonary disease (copd) and asthma) requiring any daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years. - history of significant cardiovascular disease including hypertension (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult. - history of neurological or neurodevelopmental conditions (e.g., migraines, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, guillain-barré syndrome, encephalomyelitis or transverse myelitis). - ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed. - any confirmed or suspected immunosuppressive or immunodeficient state, including hiv infection; asplenia; recurrent severe infections. - any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital). - acute illness within 72 hours prior each vaccination that in the opinion of the investigator may interfere the evaluation of safety parameters. - usage of any investigational drug ≤ 90 days prior to study entry or plan to participate in another research involving an investigational product (drug/biologic/device) within 12 months after the first study vaccination. - history of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticarial, angioedema and other significant reactions related to food, drugs, vaccines or pharmaceutical agents. - history of allergic disease or reactions likely to be exacerbated by any component of the covid-19 vaccine hipra. - use of any immunosuppressant, glucocorticoids, or other immune-modifying drugs within 2 months prior to first study vaccination; or anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. - received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination. - known disturbance of coagulation (iatrogenic or congenital) or blood dyscrasias. - known bleeding disorder (e-g- factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venepuncture. - chronic liver disease. - positive test for hiv types 1 or 2 infection, hepatitis b surface antigen (hbsag), or hepatitis c virus antibodies (hcv abs) at screening. - suspected or known current alcohol abuse or any other substances abuse (except tobacco). - history of covid-19 infection. - receipt of medications intended to prevent covid-19. - ever received an experimental vaccine against covid-19. - close contact of anyone known to have sars-cov-2 infection within 15 days prior to screening visit. - being directly involved in the conduct of the study. - any condition and/or laboratory finding that at the investigator consideration would interfere with the study or put at risk the participant.

- pregnant or lactating or intending to become pregnant or plans to breastfeed during the study. - positive pregnancy test at screening or prior to each vaccination. - any medical disease (acute, subacute, intermittent or chronic) or condition that in the opinion of the investigator compromise the volunteer's safety, preclude vaccination or compromise interpretation of the results. - history of serious psychiatric condition likely to affect participation in the study (e-g- ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication). - history of respiratory disease (e.g., chronic obstructive pulmonary disease (copd) and asthma) requiring any daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years. - history of significant cardiovascular disease including hypertension (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult. - history of neurological or neurodevelopmental conditions (e.g., migraines, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, guillain-barré syndrome, encephalomyelitis or transverse myelitis). - ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed. - any confirmed or suspected immunosuppressive or immunodeficient state, including hiv infection; asplenia; recurrent severe infections. - any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital). - acute illness within 72 hours prior each vaccination that in the opinion of the investigator may interfere the evaluation of safety parameters. - usage of any investigational drug ≤ 90 days prior to study entry or plan to participate in another research involving an investigational product (drug/biologic/device) within 12 months after the first study vaccination. - history of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticarial, angioedema and other significant reactions related to food, drugs, vaccines or pharmaceutical agents. - history of allergic disease or reactions likely to be exacerbated by any component of the covid-19 vaccine hipra. - use of any immunosuppressant, glucocorticoids, or other immune-modifying drugs within 2 months prior to first study vaccination; or anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. - received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination. - known disturbance of coagulation (iatrogenic or congenital) or blood dyscrasias. - known bleeding disorder (e-g- factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venepuncture. - chronic liver disease. - positive test for hiv types 1 or 2 infection, hepatitis b surface antigen (hbsag), or hepatitis c virus antibodies (hcv abs) at screening. - suspected or known current alcohol abuse or any other substances abuse (except tobacco). - history of covid-19 infection. - receipt of medications intended to prevent covid-19. - ever received an experimental vaccine against covid-19. - close contact of anyone known to have sars-cov-2 infection within 15 days prior to screening visit. - being directly involved in the conduct of the study. - any condition and/or laboratory finding that at the investigator consideration would interfere with the study or put at risk the participant.