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

* history of covid 19 infection within the last 3 months before screening. * previous vaccination with a sars-cov-2 vaccine other than those mentioned in inclusion criterion #2. * positive test for sars-cov-2 infection at screening. * breastfeeding with intent to continue. * acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of the responses. * history of myocarditis or pericarditis. * history of or active autoimmune disease. history of guillain-barré syndrome or reye's syndrome. persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. * known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome. * history of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure. subjects with history of skin cancer must not be vaccinated at the previous tumor site. * laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase \[ast\], alanine amino transferase \[alt\], alkaline phosphokinase \[alp\], bilirubin, or creatinine values), pulse rate, or blood pressure outside normal range at screening and deemed clinically relevant by the investigator. * clinically significant mental disorder not adequately controlled by medical treatment. * active or recent history (within 6 months before screening) of chronic alcohol abuse, or illicit drug abuse. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * history of anaphylaxis or severe allergic reaction to any vaccine. * history of any vaccinations or plan to receive any vaccinations with a live vaccine within 30 days prior to or after trial vaccination. * history of any vaccinations or plan to receive any vaccinations with a non-live vaccine within 14 days prior to or after trial vaccination. * recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior to screening, or planned blood donations during the active phase of the trial. * chronic systemic administration (defined as more than 14 days) of \>5 mg prednisone (or equivalent)/day, or any other immune-modifying drugs during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. the use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed. * history of organ transplantation, whether or not accompanied by chronic immunosuppressive therapy. * administration or planned administration of immunoglobulins and/or any blood products during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. receipt of packed red blood cells given for an emergency indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells given in emergency during an elective surgery). * use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the administration of trial vaccine, or planned administration of such a drug or vaccine throughout the trial. * involvement in this trial as site personnel. * known bleeding disorder that, in the opinion of the investigator, would contraindicate intramuscular injection.

* history of covid 19 infection within the last 3 months before screening. * previous vaccination with a sars-cov-2 vaccine other than those mentioned in inclusion criterion #2. * positive test for sars-cov-2 infection at screening. * breastfeeding with intent to continue. * acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of the responses. * history of myocarditis or pericarditis. * history of or active autoimmune disease. history of guillain-barré syndrome or reye's syndrome. persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. * known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome. * history of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure. subjects with history of skin cancer must not be vaccinated at the previous tumor site. * laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase \[ast\], alanine amino transferase \[alt\], alkaline phosphokinase \[alp\], bilirubin, or creatinine values), pulse rate, or blood pressure outside normal range at screening and deemed clinically relevant by the investigator. * clinically significant mental disorder not adequately controlled by medical treatment. * active or recent history (within 6 months before screening) of chronic alcohol abuse, or illicit drug abuse. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * history of anaphylaxis or severe allergic reaction to any vaccine. * history of any vaccinations or plan to receive any vaccinations with a live vaccine within 30 days prior to or after trial vaccination. * history of any vaccinations or plan to receive any vaccinations with a non-live vaccine within 14 days prior to or after trial vaccination. * recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior to screening, or planned blood donations during the active phase of the trial. * chronic systemic administration (defined as more than 14 days) of \>5 mg prednisone (or equivalent)/day, or any other immune-modifying drugs during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. the use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed. * history of organ transplantation, whether or not accompanied by chronic immunosuppressive therapy. * administration or planned administration of immunoglobulins and/or any blood products during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. receipt of packed red blood cells given for an emergency indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells given in emergency during an elective surgery). * use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the administration of trial vaccine, or planned administration of such a drug or vaccine throughout the trial. * involvement in this trial as site personnel. * known bleeding disorder that, in the opinion of the investigator, would contraindicate intramuscular injection.

March 8, 2023, 4 a.m. usa

history of covid 19 infection within the last 3 months before screening. previous vaccination with a sars-cov-2 vaccine other than those mentioned in inclusion criterion #2. positive test for sars-cov-2 infection at screening. breastfeeding with intent to continue. acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of the responses. history of myocarditis or pericarditis. history of or active autoimmune disease. history of guillain-barré syndrome or reye's syndrome. persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome. history of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure. subjects with history of skin cancer must not be vaccinated at the previous tumor site. laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase [ast], alanine amino transferase [alt], alkaline phosphokinase [alp], bilirubin, or creatinine values), pulse rate, or blood pressure outside normal range at screening and deemed clinically relevant by the investigator. clinically significant mental disorder not adequately controlled by medical treatment. active or recent history (within 6 months before screening) of chronic alcohol abuse, or illicit drug abuse. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. history of anaphylaxis or severe allergic reaction to any vaccine. history of any vaccinations or plan to receive any vaccinations with a live vaccine within 30 days prior to or after trial vaccination. history of any vaccinations or plan to receive any vaccinations with a non-live vaccine within 14 days prior to or after trial vaccination. recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior to screening, or planned blood donations during the active phase of the trial. chronic systemic administration (defined as more than 14 days) of >5 mg prednisone (or equivalent)/day, or any other immune-modifying drugs during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. the use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed. history of organ transplantation, whether or not accompanied by chronic immunosuppressive therapy. administration or planned administration of immunoglobulins and/or any blood products during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. receipt of packed red blood cells given for an emergency indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells given in emergency during an elective surgery). use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the administration of trial vaccine, or planned administration of such a drug or vaccine throughout the trial. involvement in this trial as site personnel. known bleeding disorder that, in the opinion of the investigator, would contraindicate intramuscular injection.

history of covid 19 infection within the last 3 months before screening. previous vaccination with a sars-cov-2 vaccine other than those mentioned in inclusion criterion #2. positive test for sars-cov-2 infection at screening. breastfeeding with intent to continue. acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of the responses. history of myocarditis or pericarditis. history of or active autoimmune disease. history of guillain-barré syndrome or reye's syndrome. persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome. history of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure. subjects with history of skin cancer must not be vaccinated at the previous tumor site. laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase [ast], alanine amino transferase [alt], alkaline phosphokinase [alp], bilirubin, or creatinine values), pulse rate, or blood pressure outside normal range at screening and deemed clinically relevant by the investigator. clinically significant mental disorder not adequately controlled by medical treatment. active or recent history (within 6 months before screening) of chronic alcohol abuse, or illicit drug abuse. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. history of anaphylaxis or severe allergic reaction to any vaccine. history of any vaccinations or plan to receive any vaccinations with a live vaccine within 30 days prior to or after trial vaccination. history of any vaccinations or plan to receive any vaccinations with a non-live vaccine within 14 days prior to or after trial vaccination. recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior to screening, or planned blood donations during the active phase of the trial. chronic systemic administration (defined as more than 14 days) of >5 mg prednisone (or equivalent)/day, or any other immune-modifying drugs during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. the use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed. history of organ transplantation, whether or not accompanied by chronic immunosuppressive therapy. administration or planned administration of immunoglobulins and/or any blood products during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. receipt of packed red blood cells given for an emergency indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells given in emergency during an elective surgery). use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the administration of trial vaccine, or planned administration of such a drug or vaccine throughout the trial. involvement in this trial as site personnel. known bleeding disorder that, in the opinion of the investigator, would contraindicate intramuscular injection.

Aug. 13, 2022, 5:30 p.m. usa

history of covid 19 infection within the last 3 months before screening. previous vaccination with a sars-cov-2 vaccine other than those mentioned in inclusion criterion #2. positive test for sars-cov-2 infection at screening. breastfeeding with intent to continue. acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of the responses. history of myocarditis or pericarditis. history of or active autoimmune disease. history of guillain-barré syndrome or reye's syndrome. persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome. history of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure. subjects with history of skin cancer must not be vaccinated at the previous tumor site. laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase [ast], alanine amino transferase [alt], alkaline phosphokinase [alp], bilirubin, or creatinine values), pulse rate, or blood pressure outside normal range at screening and deemed clinically relevant by the investigator. clinically significant mental disorder not adequately controlled by medical treatment. active or recent history (within 6 months before screening) of chronic alcohol abuse, or illicit drug abuse. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. history of anaphylaxis or severe allergic reaction to any vaccine. history of any vaccinations or plan to receive any vaccinations with a live vaccine within 30 days prior to or after trial vaccination. history of any vaccinations or plan to receive any vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination. recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior to screening, or planned blood donations during the active phase of the trial. chronic systemic administration (defined as more than 14 days) of >5 mg prednisone (or equivalent)/day, or any other immune-modifying drugs during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. the use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed. history of organ transplantation, whether or not accompanied by chronic immunosuppressive therapy. administration or planned administration of immunoglobulins and/or any blood products during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. receipt of packed red blood cells given for an emergency indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells given in emergency during an elective surgery). use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the administration of trial vaccine, or planned administration of such a drug or vaccine throughout the trial. involvement in this trial as site personnel.

history of covid 19 infection within the last 3 months before screening. previous vaccination with a sars-cov-2 vaccine other than those mentioned in inclusion criterion #2. positive test for sars-cov-2 infection at screening. breastfeeding with intent to continue. acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of the responses. history of myocarditis or pericarditis. history of or active autoimmune disease. history of guillain-barré syndrome or reye's syndrome. persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome. history of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure. subjects with history of skin cancer must not be vaccinated at the previous tumor site. laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase [ast], alanine amino transferase [alt], alkaline phosphokinase [alp], bilirubin, or creatinine values), pulse rate, or blood pressure outside normal range at screening and deemed clinically relevant by the investigator. clinically significant mental disorder not adequately controlled by medical treatment. active or recent history (within 6 months before screening) of chronic alcohol abuse, or illicit drug abuse. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. history of anaphylaxis or severe allergic reaction to any vaccine. history of any vaccinations or plan to receive any vaccinations with a live vaccine within 30 days prior to or after trial vaccination. history of any vaccinations or plan to receive any vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination. recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior to screening, or planned blood donations during the active phase of the trial. chronic systemic administration (defined as more than 14 days) of >5 mg prednisone (or equivalent)/day, or any other immune-modifying drugs during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. the use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed. history of organ transplantation, whether or not accompanied by chronic immunosuppressive therapy. administration or planned administration of immunoglobulins and/or any blood products during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. receipt of packed red blood cells given for an emergency indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells given in emergency during an elective surgery). use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the administration of trial vaccine, or planned administration of such a drug or vaccine throughout the trial. involvement in this trial as site personnel.

June 24, 2022, 9 p.m. usa

history of covid 19 infection within the last 3 months before screening. previous vaccination with a sars-cov-2 vaccine other than those mentioned in inclusion criterion #2. positive test for sars-cov-2 infection at screening. breastfeeding with intent to continue. acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of the responses. history of or active autoimmune disease. history of guillain-barré syndrome or reye's syndrome. persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome. history of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure. subjects with history of skin cancer must not be vaccinated at the previous tumor site. laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase [ast], alanine amino transferase [alt], alkaline phosphokinase [alp], bilirubin, or creatinine values), pulse rate, or blood pressure outside normal range at screening and deemed clinically relevant by the investigator. clinically significant mental disorder not adequately controlled by medical treatment. active or recent history (within 6 months before screening) of chronic alcohol abuse, or illicit drug abuse. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. history of anaphylaxis or severe allergic reaction to any vaccine. history of any vaccinations or plan to receive any vaccinations with a live vaccine within 30 days prior to or after trial vaccination. history of any vaccinations or plan to receive any vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination. recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior to screening, or planned blood donations during the active phase of the trial. chronic systemic administration (defined as more than 14 days) of >5 mg prednisone (or equivalent)/day, or any other immune-modifying drugs during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. the use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed. history of organ transplantation, whether or not accompanied by chronic immunosuppressive therapy. administration or planned administration of immunoglobulins and/or any blood products during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. receipt of packed red blood cells given for an emergency indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells given in emergency during an elective surgery). use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the administration of trial vaccine, or planned administration of such a drug or vaccine throughout the trial. involvement in this trial as site personnel.

history of covid 19 infection within the last 3 months before screening. previous vaccination with a sars-cov-2 vaccine other than those mentioned in inclusion criterion #2. positive test for sars-cov-2 infection at screening. breastfeeding with intent to continue. acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of the responses. history of or active autoimmune disease. history of guillain-barré syndrome or reye's syndrome. persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome. history of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure. subjects with history of skin cancer must not be vaccinated at the previous tumor site. laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase [ast], alanine amino transferase [alt], alkaline phosphokinase [alp], bilirubin, or creatinine values), pulse rate, or blood pressure outside normal range at screening and deemed clinically relevant by the investigator. clinically significant mental disorder not adequately controlled by medical treatment. active or recent history (within 6 months before screening) of chronic alcohol abuse, or illicit drug abuse. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. history of anaphylaxis or severe allergic reaction to any vaccine. history of any vaccinations or plan to receive any vaccinations with a live vaccine within 30 days prior to or after trial vaccination. history of any vaccinations or plan to receive any vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination. recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior to screening, or planned blood donations during the active phase of the trial. chronic systemic administration (defined as more than 14 days) of >5 mg prednisone (or equivalent)/day, or any other immune-modifying drugs during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. the use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed. history of organ transplantation, whether or not accompanied by chronic immunosuppressive therapy. administration or planned administration of immunoglobulins and/or any blood products during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. receipt of packed red blood cells given for an emergency indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells given in emergency during an elective surgery). use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the administration of trial vaccine, or planned administration of such a drug or vaccine throughout the trial. involvement in this trial as site personnel.

April 15, 2022, 11:30 p.m. usa

history of covid-19 infection within the last 6 months (cohort 1) or within the last 3 months (cohorts 2 and 3) before screening. previous vaccination with a candidate sars-cov-2 vaccine, other than those mentioned in inclusion criterion. positive test for sars-cov-2 infection at screening. breastfeeding with intent to continue. acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of the responses. history of or active autoimmune disease. history of guillain-barré syndrome or reye's syndrome. persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome. history of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure. subjects with history of skin cancer must not be vaccinated at the previous tumor site. laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase [ast], alanine amino transferase [alt], alkaline phosphokinase [ap], bilirubin, or creatinine values), pulse rate, blood pressure, or electrocardiogram (ecg) outside normal range at screening and deemed clinically relevant by the investigator. clinically significant mental disorder not adequately controlled by medical treatment. active or recent history (within 6 months before screening) of chronic alcohol abuse, or illicit drug abuse. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. history of anaphylaxis or severe allergic reaction to any vaccine. history of any vaccinations or plan to receive any vaccinations with a live vaccine within 30 days prior to or after trial vaccination. history of any vaccinations or plan to receive any vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination. recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior to screening, or planned blood donations during the active phase of the trial. chronic systemic administration (defined as more than 14 days) of >5 mg prednisone (or equivalent)/day, or any other immune-modifying drugs during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. the use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed. history of organ transplantation, whether or not accompanied by chronic immunosuppressive therapy. administration or planned administration of immunoglobulins and/or any blood products during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. receipt of packed red blood cells given for an emergency indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells given in emergency during an elective surgery). use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the administration of trial vaccine, or planned administration of such a drug or vaccine throughout the trial. involvement in this trial as site personnel.

history of covid-19 infection within the last 6 months (cohort 1) or within the last 3 months (cohorts 2 and 3) before screening. previous vaccination with a candidate sars-cov-2 vaccine, other than those mentioned in inclusion criterion. positive test for sars-cov-2 infection at screening. breastfeeding with intent to continue. acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of the responses. history of or active autoimmune disease. history of guillain-barré syndrome or reye's syndrome. persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome. history of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure. subjects with history of skin cancer must not be vaccinated at the previous tumor site. laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase [ast], alanine amino transferase [alt], alkaline phosphokinase [ap], bilirubin, or creatinine values), pulse rate, blood pressure, or electrocardiogram (ecg) outside normal range at screening and deemed clinically relevant by the investigator. clinically significant mental disorder not adequately controlled by medical treatment. active or recent history (within 6 months before screening) of chronic alcohol abuse, or illicit drug abuse. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. history of anaphylaxis or severe allergic reaction to any vaccine. history of any vaccinations or plan to receive any vaccinations with a live vaccine within 30 days prior to or after trial vaccination. history of any vaccinations or plan to receive any vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination. recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior to screening, or planned blood donations during the active phase of the trial. chronic systemic administration (defined as more than 14 days) of >5 mg prednisone (or equivalent)/day, or any other immune-modifying drugs during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. the use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed. history of organ transplantation, whether or not accompanied by chronic immunosuppressive therapy. administration or planned administration of immunoglobulins and/or any blood products during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. receipt of packed red blood cells given for an emergency indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells given in emergency during an elective surgery). use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the administration of trial vaccine, or planned administration of such a drug or vaccine throughout the trial. involvement in this trial as site personnel.