Created at Source Raw Value Validated value
Jan. 5, 2025, 10:16 p.m. usa

* any existing condition which could have affected vaccine injection and/or assessment of local reactions assessment, e.g., tattoos, severe scars, etc. * any bleeding diathesis or condition associated with prolonged bleeding that could have, in the opinion of the investigator, contraindicated intramuscular injection. * any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that, in the investigator's judgment, made the participant inappropriate for the trial. * any current febrile illness (body temperature ≥38.0°c/≥100.4°f) or other acute illness within 48 h prior to day 1/imp injection in this trial. * any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias, unless such disease was not considered relevant for participation in this trial in the investigator's judgment. * history of covid-19 and/or clinical (based on covid-19 symptoms/signs alone, if a sars cov 2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars cov 2 naat result) evidence of prior infection with sars cov 2 at screening (visit 0). * note: not applicable for part c. * history of guillain-barré syndrome. * known or suspected immunodeficiency. * history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the trial imps. * history or known allergy, hypersensitivity, or intolerance to the trial imp including any excipients of the imps in this trial. * had received any sars cov 2 vaccination other than bnt162b2 (30 µg bnt162b2 given as a course of two doses approximately 21 days apart). * note: not applicable for part c. * had received a live or live attenuated vaccine within 28 days prior to day 1/imp injection. * had received any other vaccines within 14 days before or after any imp injection, e.g., influenza, tetanus, pneumococcal, hepatitis a or b. when possible standard of care vaccinations should been planned with the trial imp administrations in mind. * individuals who received treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids were administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids were permitted. * receipt of blood/plasma products or immunoglobulin, from 60 days before imp administration or planned receipt throughout this trial. * participation in other trials involving imp within 28 days or 5 half-lives (whichever was longer) prior to visit 1 and/or during trial participation, besides participation in trials with bnt162b2. * were pregnant or breastfeeding or are planning pregnancy within 28 days after last imp treatment. * were vulnerable individuals as per international conference on harmonisation (ich) e6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. * for part c, cohorts 7, 8, and 9: vaccination with other non-rna or unauthorized covid-19 vaccines. * for part c, cohorts 7, 8, and 9: vaccination with any covid-19 vaccine after sars-cov-2 infection from january 2022 onwards (and limited to a period when there was a high prevalence of sars-cov-2 omicron infections).

* any existing condition which could have affected vaccine injection and/or assessment of local reactions assessment, e.g., tattoos, severe scars, etc. * any bleeding diathesis or condition associated with prolonged bleeding that could have, in the opinion of the investigator, contraindicated intramuscular injection. * any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that, in the investigator's judgment, made the participant inappropriate for the trial. * any current febrile illness (body temperature ≥38.0°c/≥100.4°f) or other acute illness within 48 h prior to day 1/imp injection in this trial. * any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias, unless such disease was not considered relevant for participation in this trial in the investigator's judgment. * history of covid-19 and/or clinical (based on covid-19 symptoms/signs alone, if a sars cov 2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars cov 2 naat result) evidence of prior infection with sars cov 2 at screening (visit 0). * note: not applicable for part c. * history of guillain-barré syndrome. * known or suspected immunodeficiency. * history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the trial imps. * history or known allergy, hypersensitivity, or intolerance to the trial imp including any excipients of the imps in this trial. * had received any sars cov 2 vaccination other than bnt162b2 (30 µg bnt162b2 given as a course of two doses approximately 21 days apart). * note: not applicable for part c. * had received a live or live attenuated vaccine within 28 days prior to day 1/imp injection. * had received any other vaccines within 14 days before or after any imp injection, e.g., influenza, tetanus, pneumococcal, hepatitis a or b. when possible standard of care vaccinations should been planned with the trial imp administrations in mind. * individuals who received treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids were administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids were permitted. * receipt of blood/plasma products or immunoglobulin, from 60 days before imp administration or planned receipt throughout this trial. * participation in other trials involving imp within 28 days or 5 half-lives (whichever was longer) prior to visit 1 and/or during trial participation, besides participation in trials with bnt162b2. * were pregnant or breastfeeding or are planning pregnancy within 28 days after last imp treatment. * were vulnerable individuals as per international conference on harmonisation (ich) e6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. * for part c, cohorts 7, 8, and 9: vaccination with other non-rna or unauthorized covid-19 vaccines. * for part c, cohorts 7, 8, and 9: vaccination with any covid-19 vaccine after sars-cov-2 infection from january 2022 onwards (and limited to a period when there was a high prevalence of sars-cov-2 omicron infections).

June 25, 2024, noon usa

* any existing condition which may affect vaccine injection and/or assessment of local reactions assessment, e.g., tattoos, severe scars, etc. * any bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. * any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that, in the investigator's judgment, make the participant inappropriate for the trial. * any current febrile illness (body temperature ≥38.0°c/≥100.4°f) or other acute illness within 48 h prior to day 1/imp injection in this trial. * any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias, unless such disease is not considered relevant for participation in this trial in the investigator's judgment. * history of covid-19 and/or clinical (based on covid-19 symptoms/signs alone, if a sars cov 2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars cov 2 naat result) evidence of prior infection with sars cov 2 at screening (visit 0). * note: not applicable for part c. * history of guillain-barré syndrome. * known or suspected immunodeficiency. * history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the trial imps. * history or known allergy, hypersensitivity, or intolerance to the trial imp including any excipients of the imps in this trial. * have received any sars cov 2 vaccination other than bnt162b2 (30 µg bnt162b2 given as a course of two doses approximately 21 days apart). * note: not applicable for part c. * have received a live or live attenuated vaccine within 28 days prior to day 1/imp injection. * have received any other vaccines within 14 days before or after any imp injection, e.g., influenza, tetanus, pneumococcal, hepatitis a or b. when possible standard or care vaccinations should be planned with the trial imp administrations in mind. * individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. * receipt of blood/plasma products or immunoglobulin, from 60 days before imp administration or planned receipt throughout this trial. * participation in other trials involving imp within 28 days or 5 half-lives (whichever is longer) prior to visit 1 and/or during trial participation, besides participation in trials with bnt162b2. * are pregnant or breastfeeding or are planning pregnancy within 28 days after last imp treatment. * are vulnerable individuals as per international conference on harmonisation (ich) e6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. * for part c, cohorts 7, 8, and 9: vaccination with other non-rna or unauthorized covid-19 vaccines. * for part c, cohorts 7, 8, and 9: vaccination with any covid-19 vaccine after sars-cov-2 infection from january 2022 onwards (and limited to a period when there was a high prevalence of sars-cov-2 omicron infections).

* any existing condition which may affect vaccine injection and/or assessment of local reactions assessment, e.g., tattoos, severe scars, etc. * any bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. * any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that, in the investigator's judgment, make the participant inappropriate for the trial. * any current febrile illness (body temperature ≥38.0°c/≥100.4°f) or other acute illness within 48 h prior to day 1/imp injection in this trial. * any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias, unless such disease is not considered relevant for participation in this trial in the investigator's judgment. * history of covid-19 and/or clinical (based on covid-19 symptoms/signs alone, if a sars cov 2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars cov 2 naat result) evidence of prior infection with sars cov 2 at screening (visit 0). * note: not applicable for part c. * history of guillain-barré syndrome. * known or suspected immunodeficiency. * history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the trial imps. * history or known allergy, hypersensitivity, or intolerance to the trial imp including any excipients of the imps in this trial. * have received any sars cov 2 vaccination other than bnt162b2 (30 µg bnt162b2 given as a course of two doses approximately 21 days apart). * note: not applicable for part c. * have received a live or live attenuated vaccine within 28 days prior to day 1/imp injection. * have received any other vaccines within 14 days before or after any imp injection, e.g., influenza, tetanus, pneumococcal, hepatitis a or b. when possible standard or care vaccinations should be planned with the trial imp administrations in mind. * individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. * receipt of blood/plasma products or immunoglobulin, from 60 days before imp administration or planned receipt throughout this trial. * participation in other trials involving imp within 28 days or 5 half-lives (whichever is longer) prior to visit 1 and/or during trial participation, besides participation in trials with bnt162b2. * are pregnant or breastfeeding or are planning pregnancy within 28 days after last imp treatment. * are vulnerable individuals as per international conference on harmonisation (ich) e6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. * for part c, cohorts 7, 8, and 9: vaccination with other non-rna or unauthorized covid-19 vaccines. * for part c, cohorts 7, 8, and 9: vaccination with any covid-19 vaccine after sars-cov-2 infection from january 2022 onwards (and limited to a period when there was a high prevalence of sars-cov-2 omicron infections).

Nov. 19, 2023, noon usa

any existing condition which may affect vaccine injection and/or assessment of local reactions assessment, e.g., tattoos, severe scars, etc. any bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that, in the investigator's judgment, make the participant inappropriate for the trial. any current febrile illness (body temperature ≥38.0°c/≥100.4°f) or other acute illness within 48 h prior to day 1/imp injection in this trial. any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias, unless such disease is not considered relevant for participation in this trial in the investigator's judgment. history of covid-19 and/or clinical (based on covid-19 symptoms/signs alone, if a sars cov 2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars cov 2 naat result) evidence of prior infection with sars cov 2 at screening (visit 0). note: not applicable for part c. history of guillain-barré syndrome. known or suspected immunodeficiency. history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the trial imps. history or known allergy, hypersensitivity, or intolerance to the trial imp including any excipients of the imps in this trial. have received any sars cov 2 vaccination other than bnt162b2 (30 µg bnt162b2 given as a course of two doses approximately 21 days apart). note: not applicable for part c. have received a live or live attenuated vaccine within 28 days prior to day 1/imp injection. have received any other vaccines within 14 days before or after any imp injection, e.g., influenza, tetanus, pneumococcal, hepatitis a or b. when possible standard or care vaccinations should be planned with the trial imp administrations in mind. individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. receipt of blood/plasma products or immunoglobulin, from 60 days before imp administration or planned receipt throughout this trial. participation in other trials involving imp within 28 days or 5 half-lives (whichever is longer) prior to visit 1 and/or during trial participation, besides participation in trials with bnt162b2. are pregnant or breastfeeding or are planning pregnancy within 28 days after last imp treatment. are vulnerable individuals as per international conference on harmonisation (ich) e6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. for part c, cohorts 7, 8, and 9: vaccination with other non-rna or unauthorized covid-19 vaccines. for part c, cohorts 7, 8, and 9: vaccination with any covid-19 vaccine after sars-cov-2 infection from january 2022 onwards (and limited to a period when there was a high prevalence of sars-cov-2 omicron infections).

any existing condition which may affect vaccine injection and/or assessment of local reactions assessment, e.g., tattoos, severe scars, etc. any bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that, in the investigator's judgment, make the participant inappropriate for the trial. any current febrile illness (body temperature ≥38.0°c/≥100.4°f) or other acute illness within 48 h prior to day 1/imp injection in this trial. any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias, unless such disease is not considered relevant for participation in this trial in the investigator's judgment. history of covid-19 and/or clinical (based on covid-19 symptoms/signs alone, if a sars cov 2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars cov 2 naat result) evidence of prior infection with sars cov 2 at screening (visit 0). note: not applicable for part c. history of guillain-barré syndrome. known or suspected immunodeficiency. history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the trial imps. history or known allergy, hypersensitivity, or intolerance to the trial imp including any excipients of the imps in this trial. have received any sars cov 2 vaccination other than bnt162b2 (30 µg bnt162b2 given as a course of two doses approximately 21 days apart). note: not applicable for part c. have received a live or live attenuated vaccine within 28 days prior to day 1/imp injection. have received any other vaccines within 14 days before or after any imp injection, e.g., influenza, tetanus, pneumococcal, hepatitis a or b. when possible standard or care vaccinations should be planned with the trial imp administrations in mind. individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. receipt of blood/plasma products or immunoglobulin, from 60 days before imp administration or planned receipt throughout this trial. participation in other trials involving imp within 28 days or 5 half-lives (whichever is longer) prior to visit 1 and/or during trial participation, besides participation in trials with bnt162b2. are pregnant or breastfeeding or are planning pregnancy within 28 days after last imp treatment. are vulnerable individuals as per international conference on harmonisation (ich) e6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. for part c, cohorts 7, 8, and 9: vaccination with other non-rna or unauthorized covid-19 vaccines. for part c, cohorts 7, 8, and 9: vaccination with any covid-19 vaccine after sars-cov-2 infection from january 2022 onwards (and limited to a period when there was a high prevalence of sars-cov-2 omicron infections).

Sept. 23, 2022, 4 a.m. usa

any existing condition which may affect vaccine injection and/or assessment of local reactions assessment, e.g., tattoos, severe scars, etc. any bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that, in the investigator's judgment, make the participant inappropriate for the trial. any current febrile illness (body temperature ≥38.0°c/≥100.4°f) or other acute illness within 48 h prior to day 1/imp injection in this trial. any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias. history of covid-19 and/or clinical (based on covid-19 symptoms/signs alone, if a sars cov 2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars cov 2 naat result) evidence of prior infection with sars cov 2 at screening (visit 0). note: not applicable for part c. history of guillain-barré syndrome. known or suspected immunodeficiency. history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the trial imps. history or known allergy, hypersensitivity, or intolerance to the trial imp including any excipients of the imps in this trial. have received any sars cov 2 vaccination other than bnt162b2 (30 µg bnt162b2 given as a course of two doses approximately 21 days apart). note: not applicable for part c. have received a live or live attenuated vaccine within 28 days prior to day 1/imp injection. have received any other vaccines within 14 days before or after any imp injection, e.g., influenza, tetanus, pneumococcal, hepatitis a or b. when possible standard or care vaccinations should be planned with the trial imp administrations in mind. individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. receipt of blood/plasma products or immunoglobulin, from 60 days before imp administration or planned receipt throughout this trial. participation in other trials involving imp within 28 days or 5 half-lives (whichever is longer) prior to visit 1 and/or during trial participation, besides participation in trials with bnt162b2. are pregnant or breastfeeding or are planning pregnancy within 28 days after last imp treatment. are vulnerable individuals as per international conference on harmonisation (ich) e6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. for part c, cohorts 7, 8, and 9: vaccination with other non-rna or unauthorized covid-19 vaccines. for part c, cohorts 7, 8, and 9: vaccination with any covid-19 vaccine after sars-cov-2 infection from january 2022 onwards (and limited to a period when there was a high prevalence of sars-cov-2 omicron infections).

any existing condition which may affect vaccine injection and/or assessment of local reactions assessment, e.g., tattoos, severe scars, etc. any bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that, in the investigator's judgment, make the participant inappropriate for the trial. any current febrile illness (body temperature ≥38.0°c/≥100.4°f) or other acute illness within 48 h prior to day 1/imp injection in this trial. any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias. history of covid-19 and/or clinical (based on covid-19 symptoms/signs alone, if a sars cov 2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars cov 2 naat result) evidence of prior infection with sars cov 2 at screening (visit 0). note: not applicable for part c. history of guillain-barré syndrome. known or suspected immunodeficiency. history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the trial imps. history or known allergy, hypersensitivity, or intolerance to the trial imp including any excipients of the imps in this trial. have received any sars cov 2 vaccination other than bnt162b2 (30 µg bnt162b2 given as a course of two doses approximately 21 days apart). note: not applicable for part c. have received a live or live attenuated vaccine within 28 days prior to day 1/imp injection. have received any other vaccines within 14 days before or after any imp injection, e.g., influenza, tetanus, pneumococcal, hepatitis a or b. when possible standard or care vaccinations should be planned with the trial imp administrations in mind. individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. receipt of blood/plasma products or immunoglobulin, from 60 days before imp administration or planned receipt throughout this trial. participation in other trials involving imp within 28 days or 5 half-lives (whichever is longer) prior to visit 1 and/or during trial participation, besides participation in trials with bnt162b2. are pregnant or breastfeeding or are planning pregnancy within 28 days after last imp treatment. are vulnerable individuals as per international conference on harmonisation (ich) e6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. for part c, cohorts 7, 8, and 9: vaccination with other non-rna or unauthorized covid-19 vaccines. for part c, cohorts 7, 8, and 9: vaccination with any covid-19 vaccine after sars-cov-2 infection from january 2022 onwards (and limited to a period when there was a high prevalence of sars-cov-2 omicron infections).

April 23, 2022, 1:30 a.m. usa

any existing condition which may affect vaccine injection and/or assessment of local reactions assessment, e.g., tattoos, severe scars, etc. any bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that, in the investigator's judgment, make the participant inappropriate for the trial. any current febrile illness (body temperature ≥38.0°c/≥100.4°f) or other acute illness within 48 h prior to day 1/imp injection in this trial. any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias. history of covid-19 and/or clinical (based on covid-19 symptoms/signs alone, if a sars cov 2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars cov 2 naat result) evidence of prior infection with sars cov 2 at screening (visit 0). note: not applicable for part c. history of guillain-barré syndrome. known or suspected immunodeficiency. history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the trial imps. history or known allergy, hypersensitivity, or intolerance to the trial imp including any excipients of the imps in this trial. have received any sars cov 2 vaccination other than bnt162b2 (30 µg bnt162b2 given as a course of two doses approximately 21 days apart). note: not applicable for part c. have received a live or live attenuated vaccine within 28 days prior to day 1/imp injection. have received any other vaccines within 14 days before or after any imp injection, e.g., influenza, tetanus, pneumococcal, hepatitis a or b. when possible standard or care vaccinations should be planned with the trial imp administrations in mind. individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. receipt of blood/plasma products or immunoglobulin, from 60 days before imp administration or planned receipt throughout this trial. participation in other trials involving imp within 28 days or 5 half-lives (whichever is longer) prior to visit 1 and/or during trial participation, besides participation in trials with bnt162b2. are pregnant or breastfeeding or are planning pregnancy within 28 days after last imp treatment. are vulnerable individuals as per international conference on harmonisation (ich) e6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. for part c, cohorts 7, 8, and 9: vaccination with other non-rna or unauthorized covid-19 vaccines and/or vaccination with any covid-19 vaccine after sars-cov-2 infection from january 2022 on (and limited to a period when there was a high prevalence of sars-cov-2 omicron infections).

any existing condition which may affect vaccine injection and/or assessment of local reactions assessment, e.g., tattoos, severe scars, etc. any bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that, in the investigator's judgment, make the participant inappropriate for the trial. any current febrile illness (body temperature ≥38.0°c/≥100.4°f) or other acute illness within 48 h prior to day 1/imp injection in this trial. any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias. history of covid-19 and/or clinical (based on covid-19 symptoms/signs alone, if a sars cov 2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars cov 2 naat result) evidence of prior infection with sars cov 2 at screening (visit 0). note: not applicable for part c. history of guillain-barré syndrome. known or suspected immunodeficiency. history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the trial imps. history or known allergy, hypersensitivity, or intolerance to the trial imp including any excipients of the imps in this trial. have received any sars cov 2 vaccination other than bnt162b2 (30 µg bnt162b2 given as a course of two doses approximately 21 days apart). note: not applicable for part c. have received a live or live attenuated vaccine within 28 days prior to day 1/imp injection. have received any other vaccines within 14 days before or after any imp injection, e.g., influenza, tetanus, pneumococcal, hepatitis a or b. when possible standard or care vaccinations should be planned with the trial imp administrations in mind. individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. receipt of blood/plasma products or immunoglobulin, from 60 days before imp administration or planned receipt throughout this trial. participation in other trials involving imp within 28 days or 5 half-lives (whichever is longer) prior to visit 1 and/or during trial participation, besides participation in trials with bnt162b2. are pregnant or breastfeeding or are planning pregnancy within 28 days after last imp treatment. are vulnerable individuals as per international conference on harmonisation (ich) e6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. for part c, cohorts 7, 8, and 9: vaccination with other non-rna or unauthorized covid-19 vaccines and/or vaccination with any covid-19 vaccine after sars-cov-2 infection from january 2022 on (and limited to a period when there was a high prevalence of sars-cov-2 omicron infections).

Aug. 14, 2021, 5 p.m. usa

- any existing condition which may affect vaccine injection and/or assessment of local reactions assessment, e.g., tattoos, severe scars, etc. - any bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. - any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that, in the investigator's judgment, make the participant inappropriate for the trial. - any current febrile illness (body temperature ≥38.0°c/≥100.4°f) or other acute illness within 48 h prior to day 1/imp injection in this trial. - any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias. - history of covid-19 and/or clinical (based on covid-19 symptoms/signs alone, if a sars cov 2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars cov 2 naat result) evidence of prior infection with sars cov 2 at screening (visit 0). - history of guillain-barré syndrome. - known or suspected immunodeficiency. - history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the trial imps. - history or known allergy, hypersensitivity, or intolerance to the trial imp including any excipients of the imps in this trial. - have received any sars cov 2 vaccination other than bnt162b2 (30 µg bnt162b2 given as a course of two doses at least 21 days apart). - have received a live or live attenuated vaccine within 28 days prior to day 1/imp injection. - have received any other vaccines within 14 days before or after any imp injection, e.g., influenza, tetanus, pneumococcal, hepatitis a or b. when possible standard or care vaccinations should be planned with the trial imp administrations in mind. - individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. - receipt of blood/plasma products or immunoglobulin, from 60 days before imp administration or planned receipt throughout this trial. - participation in other trials involving imp within 28 days or 5 half-lives (whichever is longer) prior to visit 1 and/or during trial participation, besides participation in trials with bnt162b2. - are pregnant or breastfeeding or are planning pregnancy during this trial. - are vulnerable individuals as per international conference on harmonisation (ich) e6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.

- any existing condition which may affect vaccine injection and/or assessment of local reactions assessment, e.g., tattoos, severe scars, etc. - any bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. - any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that, in the investigator's judgment, make the participant inappropriate for the trial. - any current febrile illness (body temperature ≥38.0°c/≥100.4°f) or other acute illness within 48 h prior to day 1/imp injection in this trial. - any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias. - history of covid-19 and/or clinical (based on covid-19 symptoms/signs alone, if a sars cov 2 naat result was not available) or microbiological (based on covid-19 symptoms/signs and a positive sars cov 2 naat result) evidence of prior infection with sars cov 2 at screening (visit 0). - history of guillain-barré syndrome. - known or suspected immunodeficiency. - history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the trial imps. - history or known allergy, hypersensitivity, or intolerance to the trial imp including any excipients of the imps in this trial. - have received any sars cov 2 vaccination other than bnt162b2 (30 µg bnt162b2 given as a course of two doses at least 21 days apart). - have received a live or live attenuated vaccine within 28 days prior to day 1/imp injection. - have received any other vaccines within 14 days before or after any imp injection, e.g., influenza, tetanus, pneumococcal, hepatitis a or b. when possible standard or care vaccinations should be planned with the trial imp administrations in mind. - individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. - receipt of blood/plasma products or immunoglobulin, from 60 days before imp administration or planned receipt throughout this trial. - participation in other trials involving imp within 28 days or 5 half-lives (whichever is longer) prior to visit 1 and/or during trial participation, besides participation in trials with bnt162b2. - are pregnant or breastfeeding or are planning pregnancy during this trial. - are vulnerable individuals as per international conference on harmonisation (ich) e6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.