Created at Source Raw Value Validated value
June 25, 2024, noon usa

* women with a positive blood (β-hcg) pregnancy test * lactating women * history of covid-19 infection or showing covid-19 infection symptoms * having had contact to people with known covid-19 infection in the last 14 days * having fever (\> 37.4oc in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea. * positive real time rt-pcr covid-19 test. * leukemia or neoplasm in history. * persons with autoimmune diseases * allergic diathesis or any clinically significant allergic disease (i.e. asthma) * any condition that might impair the immune response * recent or current immunosuppressive medication * any other vaccine application 30 days before the first dose * presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological, psychiatric or other major diseases; * disruption of platelets or other blood clotting disorders, which may cause contraindications to intramuscular administration * clinically significant illness within 4 weeks before the start of the study. especially any acute or chronic illness seizures. * any regular intake or administration of any prescribed systemic or topical medication within 2 weeks prior to the start of the study; in the case of intake or administration of any prescribed systemic or topical medication within 4 weeks before the start of the study because of an insignificant illness, this should be stated in the crf. * intake or administration of otc medication (including herbal remedies) which may have an effect on the study according to the investigator within 2 weeks prior to the start of the study * volunteers who received antiviral drugs, immunoglobulins or blood transfusions or any other investigational drug within 4 weeks prior to the first study product administration * concomitant intake or administration of any systemic or topical drugs (including herbal remedies) on the application days * treatment with any investigational drug (i.e., drug not yet approved) in the last 4 weeks before beginning of the trial * medication with drugs known to alter organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 1 month (4 weeks) * donation of blood or plasma more than 450 ml within the last 2 months (8 weeks) or any amount within the last month (4 weeks) * supine blood pressure, after resting for 5 min, higher than 140/90 or lower than 100/60 mmhg * supine pulse rate, after resting for 5 min, outside the range of 50 - 100 beats/min * supine respiratory rate, after resting for 5 min, outside the range of 15 - 18 breathings / min * laboratory values (appendix 5) outside normal range with clinical relevance at entry examination * alcohol abuse i.e. regular use of more than 2 units of alcohol per day or a history of alcoholism or drug/chemical abuse (one unit of alcohol equals ½ l of beer, 200 ml wine or 50 ml of spirits) or recovered alcoholics * caffeine abuse i.e. regular use of more than 750 mg/day caffeine * alcoholic or methylxanthine-containing beverages or foods (coffee, tea, coke, chocolate) and fruit-juice from 24 hours prior to each application * smoking of more than 10 cigarettes or equivalent per day, no smoking before application * vegetarian or any special diet due to any reason * knowledge to have any type of parenterally transmitted hepatitis or carrier of the hbsag (hbsag test positive) * hiv-ab test positive * test on anti-hcv antibodies positive * legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study * evidence of an uncooperative attitude.

* women with a positive blood (β-hcg) pregnancy test * lactating women * history of covid-19 infection or showing covid-19 infection symptoms * having had contact to people with known covid-19 infection in the last 14 days * having fever (\> 37.4oc in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea. * positive real time rt-pcr covid-19 test. * leukemia or neoplasm in history. * persons with autoimmune diseases * allergic diathesis or any clinically significant allergic disease (i.e. asthma) * any condition that might impair the immune response * recent or current immunosuppressive medication * any other vaccine application 30 days before the first dose * presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological, psychiatric or other major diseases; * disruption of platelets or other blood clotting disorders, which may cause contraindications to intramuscular administration * clinically significant illness within 4 weeks before the start of the study. especially any acute or chronic illness seizures. * any regular intake or administration of any prescribed systemic or topical medication within 2 weeks prior to the start of the study; in the case of intake or administration of any prescribed systemic or topical medication within 4 weeks before the start of the study because of an insignificant illness, this should be stated in the crf. * intake or administration of otc medication (including herbal remedies) which may have an effect on the study according to the investigator within 2 weeks prior to the start of the study * volunteers who received antiviral drugs, immunoglobulins or blood transfusions or any other investigational drug within 4 weeks prior to the first study product administration * concomitant intake or administration of any systemic or topical drugs (including herbal remedies) on the application days * treatment with any investigational drug (i.e., drug not yet approved) in the last 4 weeks before beginning of the trial * medication with drugs known to alter organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 1 month (4 weeks) * donation of blood or plasma more than 450 ml within the last 2 months (8 weeks) or any amount within the last month (4 weeks) * supine blood pressure, after resting for 5 min, higher than 140/90 or lower than 100/60 mmhg * supine pulse rate, after resting for 5 min, outside the range of 50 - 100 beats/min * supine respiratory rate, after resting for 5 min, outside the range of 15 - 18 breathings / min * laboratory values (appendix 5) outside normal range with clinical relevance at entry examination * alcohol abuse i.e. regular use of more than 2 units of alcohol per day or a history of alcoholism or drug/chemical abuse (one unit of alcohol equals ½ l of beer, 200 ml wine or 50 ml of spirits) or recovered alcoholics * caffeine abuse i.e. regular use of more than 750 mg/day caffeine * alcoholic or methylxanthine-containing beverages or foods (coffee, tea, coke, chocolate) and fruit-juice from 24 hours prior to each application * smoking of more than 10 cigarettes or equivalent per day, no smoking before application * vegetarian or any special diet due to any reason * knowledge to have any type of parenterally transmitted hepatitis or carrier of the hbsag (hbsag test positive) * hiv-ab test positive * test on anti-hcv antibodies positive * legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study * evidence of an uncooperative attitude.

April 6, 2021, 12:31 a.m. usa

- women with a positive blood (β-hcg) pregnancy test - lactating women - history of covid-19 infection or showing covid-19 infection symptoms - having had contact to people with known covid-19 infection in the last 14 days - having fever (> 37.4oc in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea. - positive real time rt-pcr covid-19 test. - leukemia or neoplasm in history. - persons with autoimmune diseases - allergic diathesis or any clinically significant allergic disease (i.e. asthma) - any condition that might impair the immune response - recent or current immunosuppressive medication - any other vaccine application 30 days before the first dose - presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological, psychiatric or other major diseases; - disruption of platelets or other blood clotting disorders, which may cause contraindications to intramuscular administration - clinically significant illness within 4 weeks before the start of the study. especially any acute or chronic illness seizures. - any regular intake or administration of any prescribed systemic or topical medication within 2 weeks prior to the start of the study; in the case of intake or administration of any prescribed systemic or topical medication within 4 weeks before the start of the study because of an insignificant illness, this should be stated in the crf. - intake or administration of otc medication (including herbal remedies) which may have an effect on the study according to the investigator within 2 weeks prior to the start of the study - volunteers who received antiviral drugs, immunoglobulins or blood transfusions or any other investigational drug within 4 weeks prior to the first study product administration - concomitant intake or administration of any systemic or topical drugs (including herbal remedies) on the application days - treatment with any investigational drug (i.e., drug not yet approved) in the last 4 weeks before beginning of the trial - medication with drugs known to alter organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 1 month (4 weeks) - donation of blood or plasma more than 450 ml within the last 2 months (8 weeks) or any amount within the last month (4 weeks) - supine blood pressure, after resting for 5 min, higher than 140/90 or lower than 100/60 mmhg - supine pulse rate, after resting for 5 min, outside the range of 50 - 100 beats/min - supine respiratory rate, after resting for 5 min, outside the range of 15 - 18 breathings / min - laboratory values (appendix 5) outside normal range with clinical relevance at entry examination - alcohol abuse i.e. regular use of more than 2 units of alcohol per day or a history of alcoholism or drug/chemical abuse (one unit of alcohol equals ½ l of beer, 200 ml wine or 50 ml of spirits) or recovered alcoholics - caffeine abuse i.e. regular use of more than 750 mg/day caffeine - alcoholic or methylxanthine-containing beverages or foods (coffee, tea, coke, chocolate) and fruit-juice from 24 hours prior to each application - smoking of more than 10 cigarettes or equivalent per day, no smoking before application - vegetarian or any special diet due to any reason - knowledge to have any type of parenterally transmitted hepatitis or carrier of the hbsag (hbsag test positive) - hiv-ab test positive - test on anti-hcv antibodies positive - legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study - evidence of an uncooperative attitude.

- women with a positive blood (β-hcg) pregnancy test - lactating women - history of covid-19 infection or showing covid-19 infection symptoms - having had contact to people with known covid-19 infection in the last 14 days - having fever (> 37.4oc in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea. - positive real time rt-pcr covid-19 test. - leukemia or neoplasm in history. - persons with autoimmune diseases - allergic diathesis or any clinically significant allergic disease (i.e. asthma) - any condition that might impair the immune response - recent or current immunosuppressive medication - any other vaccine application 30 days before the first dose - presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological, psychiatric or other major diseases; - disruption of platelets or other blood clotting disorders, which may cause contraindications to intramuscular administration - clinically significant illness within 4 weeks before the start of the study. especially any acute or chronic illness seizures. - any regular intake or administration of any prescribed systemic or topical medication within 2 weeks prior to the start of the study; in the case of intake or administration of any prescribed systemic or topical medication within 4 weeks before the start of the study because of an insignificant illness, this should be stated in the crf. - intake or administration of otc medication (including herbal remedies) which may have an effect on the study according to the investigator within 2 weeks prior to the start of the study - volunteers who received antiviral drugs, immunoglobulins or blood transfusions or any other investigational drug within 4 weeks prior to the first study product administration - concomitant intake or administration of any systemic or topical drugs (including herbal remedies) on the application days - treatment with any investigational drug (i.e., drug not yet approved) in the last 4 weeks before beginning of the trial - medication with drugs known to alter organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 1 month (4 weeks) - donation of blood or plasma more than 450 ml within the last 2 months (8 weeks) or any amount within the last month (4 weeks) - supine blood pressure, after resting for 5 min, higher than 140/90 or lower than 100/60 mmhg - supine pulse rate, after resting for 5 min, outside the range of 50 - 100 beats/min - supine respiratory rate, after resting for 5 min, outside the range of 15 - 18 breathings / min - laboratory values (appendix 5) outside normal range with clinical relevance at entry examination - alcohol abuse i.e. regular use of more than 2 units of alcohol per day or a history of alcoholism or drug/chemical abuse (one unit of alcohol equals ½ l of beer, 200 ml wine or 50 ml of spirits) or recovered alcoholics - caffeine abuse i.e. regular use of more than 750 mg/day caffeine - alcoholic or methylxanthine-containing beverages or foods (coffee, tea, coke, chocolate) and fruit-juice from 24 hours prior to each application - smoking of more than 10 cigarettes or equivalent per day, no smoking before application - vegetarian or any special diet due to any reason - knowledge to have any type of parenterally transmitted hepatitis or carrier of the hbsag (hbsag test positive) - hiv-ab test positive - test on anti-hcv antibodies positive - legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study - evidence of an uncooperative attitude.