-known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on investigator or designee's judgment. self-reported thrombocytopenia, contraindicating intramuscular (im) vaccination based on investigator's judgment. bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating im vaccination based on investigator's judgment. unstable acute or chronic illness that in the opinion of the investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures. receipt of solid-organ or bone marrow transplants in the past 180 days. receipt of anti-cancer chemotherapy in the last 90 days. receipt of immunoglobulins, blood, or blood-derived products in the past 3 months. moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°c \[≥ 100.4°f\]). a prospective participant should not be included in the trial until the condition has resolved or the febrile event has subsided. receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention. applicable to original phase ii cohort, supplemental cohort 1 and cohort 2 comparator group: prior administration of a coronavirus vaccine (sars-cov-2, sars-cov, middle east respiratory syndrome \[mers-cov\]). participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study trial period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. exclusion criterion for the supplemental cohort 1 and cohort 2 comparator group: positive rapid diagnostic test for sars-cov-2 antibodies at time of enrollment. exclusion criterion for participants in supplemental cohort 2 who were primed as participant in the original phase ii cohort of the present study: receipt of authorized/conditionally approved covid-19 vaccine after enrollment in original phase 2 cohort. exclusion criterion for all booster groups: documented virologically-confirmed sars-cov-2 infection (by naat) after first dose of primary immunization.

-known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on investigator or designee's judgment. self-reported thrombocytopenia, contraindicating intramuscular (im) vaccination based on investigator's judgment. bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating im vaccination based on investigator's judgment. unstable acute or chronic illness that in the opinion of the investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures. receipt of solid-organ or bone marrow transplants in the past 180 days. receipt of anti-cancer chemotherapy in the last 90 days. receipt of immunoglobulins, blood, or blood-derived products in the past 3 months. moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°c \[≥ 100.4°f\]). a prospective participant should not be included in the trial until the condition has resolved or the febrile event has subsided. receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention. applicable to original phase ii cohort, supplemental cohort 1 and cohort 2 comparator group: prior administration of a coronavirus vaccine (sars-cov-2, sars-cov, middle east respiratory syndrome \[mers-cov\]). participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study trial period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. exclusion criterion for the supplemental cohort 1 and cohort 2 comparator group: positive rapid diagnostic test for sars-cov-2 antibodies at time of enrollment. exclusion criterion for participants in supplemental cohort 2 who were primed as participant in the original phase ii cohort of the present study: receipt of authorized/conditionally approved covid-19 vaccine after enrollment in original phase 2 cohort. exclusion criterion for all booster groups: documented virologically-confirmed sars-cov-2 infection (by naat) after first dose of primary immunization.

-known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on investigator or designee's judgment. self-reported thrombocytopenia, contraindicating intramuscular (im) vaccination based on investigator's judgment. bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating im vaccination based on investigator's judgment. unstable acute or chronic illness that in the opinion of the investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures. receipt of solid-organ or bone marrow transplants in the past 180 days. receipt of anti-cancer chemotherapy in the last 90 days. receipt of immunoglobulins, blood, or blood-derived products in the past 3 months. moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°c [≥ 100.4°f]). a prospective participant should not be included in the trial until the condition has resolved or the febrile event has subsided. receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention. applicable to original phase ii cohort, supplemental cohort 1 and cohort 2 comparator group: prior administration of a coronavirus vaccine (sars-cov-2, sars-cov, middle east respiratory syndrome [mers-cov]). participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study trial period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. exclusion criterion for the supplemental cohort 1 and cohort 2 comparator group: positive rapid diagnostic test for sars-cov-2 antibodies at time of enrollment. exclusion criterion for participants in supplemental cohort 2 who were primed as participant in the original phase ii cohort of the present study: receipt of authorized/conditionally approved covid-19 vaccine after enrollment in original phase 2 cohort. exclusion criterion for all booster groups: documented virologically-confirmed sars-cov-2 infection (by naat) after first dose of primary immunization.

-known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on investigator or designee's judgment. self-reported thrombocytopenia, contraindicating intramuscular (im) vaccination based on investigator's judgment. bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating im vaccination based on investigator's judgment. unstable acute or chronic illness that in the opinion of the investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures. receipt of solid-organ or bone marrow transplants in the past 180 days. receipt of anti-cancer chemotherapy in the last 90 days. receipt of immunoglobulins, blood, or blood-derived products in the past 3 months. moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°c [≥ 100.4°f]). a prospective participant should not be included in the trial until the condition has resolved or the febrile event has subsided. receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention. applicable to original phase ii cohort, supplemental cohort 1 and cohort 2 comparator group: prior administration of a coronavirus vaccine (sars-cov-2, sars-cov, middle east respiratory syndrome [mers-cov]). participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study trial period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. exclusion criterion for the supplemental cohort 1 and cohort 2 comparator group: positive rapid diagnostic test for sars-cov-2 antibodies at time of enrollment. exclusion criterion for participants in supplemental cohort 2 who were primed as participant in the original phase ii cohort of the present study: receipt of authorized/conditionally approved covid-19 vaccine after enrollment in original phase 2 cohort. exclusion criterion for all booster groups: documented virologically-confirmed sars-cov-2 infection (by naat) after first dose of primary immunization.

known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on investigator or designee's judgment. self-reported thrombocytopenia, contraindicating intramuscular (im) vaccination based on investigator's judgment. bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating im vaccination based on investigator's judgment. unstable acute or chronic illness that in the opinion of the investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures. receipt of solid-organ or bone marrow transplants in the past 180 days. receipt of anti-cancer chemotherapy in the last 90 days. receipt of immunoglobulins, blood, or blood-derived products in the past 3 months. moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°c [≥ 100.4°f]). a prospective participant should not be included in the trial until the condition has resolved or the febrile event has subsided. receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention. applicable to original phase ii cohort, supplemental cohort 1 and cohort 2 comparator group, and supplemental variant prime cohort 3 groups: prior administration of a coronavirus vaccine (sars-cov-2, sars-cov, middle east respiratory syndrome [mers-cov]). participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. exclusion criterion for the supplemental cohort 1 and cohort 2 comparator group and for the 3 supplemental variant prime cohort 3 groups: positive rapid diagnostic test for sars-cov-2 antibodies at time of enrollment. exclusion criterion for participants in supplemental cohort 2 who were primed as participant in the original phase ii cohort of the present study): receipt of authorized/conditionally approved covid-19 vaccine after enrollment in original phase 2 cohort. exclusion criterion for all booster groups: documented virologically-confirmed sars-cov-2 infection (by naat) after first dose of primary immunization.

known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on investigator or designee's judgment. self-reported thrombocytopenia, contraindicating intramuscular (im) vaccination based on investigator's judgment. bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating im vaccination based on investigator's judgment. unstable acute or chronic illness that in the opinion of the investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures. receipt of solid-organ or bone marrow transplants in the past 180 days. receipt of anti-cancer chemotherapy in the last 90 days. receipt of immunoglobulins, blood, or blood-derived products in the past 3 months. moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°c [≥ 100.4°f]). a prospective participant should not be included in the trial until the condition has resolved or the febrile event has subsided. receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention. applicable to original phase ii cohort, supplemental cohort 1 and cohort 2 comparator group, and supplemental variant prime cohort 3 groups: prior administration of a coronavirus vaccine (sars-cov-2, sars-cov, middle east respiratory syndrome [mers-cov]). participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. exclusion criterion for the supplemental cohort 1 and cohort 2 comparator group and for the 3 supplemental variant prime cohort 3 groups: positive rapid diagnostic test for sars-cov-2 antibodies at time of enrollment. exclusion criterion for participants in supplemental cohort 2 who were primed as participant in the original phase ii cohort of the present study): receipt of authorized/conditionally approved covid-19 vaccine after enrollment in original phase 2 cohort. exclusion criterion for all booster groups: documented virologically-confirmed sars-cov-2 infection (by naat) after first dose of primary immunization.

- known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. - dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on investigator or designee's judgment. - self-reported thrombocytopenia, contraindicating intramuscular (im) vaccination based on investigator's judgment. - bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating im vaccination based on investigator's judgment. - unstable acute or chronic illness that in the opinion of the investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures. - receipt of solid-organ or bone marrow transplants in the past 180 days. - receipt of anti-cancer chemotherapy in the last 90 days. - moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°c [≥ 100.4°f]). a prospective participant should not be included in the trial until the condition has resolved or the febrile event has subsided. - receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention. - applicable to original phase ii cohort, supplemental cohort 1 and cohort 2 comparator group, and supplemental variant prime cohort 3 groups: prior administration of a coronavirus vaccine (sars-cov-2, sars-cov, middle east respiratory syndrome [mers-cov]). - participation at the time of trial enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. - exclusion criterion for the supplemental cohort 1 and cohort 2 comparator group and for the 3 supplemental variant prime cohort 3 groups: positive rapid diagnostic test for sars-cov-2 antibodies at time of enrollment. - exclusion criterion for participants in supplemental cohort 2 who were primed as participant in the original phase ii cohort of the present study): receipt of authorized/conditionally approved covid-19 vaccine after enrollment in original phase 2 cohort. - exclusion criterion for all booster groups: documented virologically-confirmed sars-cov-2 infection (by naat) after first dose of primary immunization. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

- known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. - dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on investigator or designee's judgment. - self-reported thrombocytopenia, contraindicating intramuscular (im) vaccination based on investigator's judgment. - bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating im vaccination based on investigator's judgment. - unstable acute or chronic illness that in the opinion of the investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures. - receipt of solid-organ or bone marrow transplants in the past 180 days. - receipt of anti-cancer chemotherapy in the last 90 days. - moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°c [≥ 100.4°f]). a prospective participant should not be included in the trial until the condition has resolved or the febrile event has subsided. - receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention. - applicable to original phase ii cohort, supplemental cohort 1 and cohort 2 comparator group, and supplemental variant prime cohort 3 groups: prior administration of a coronavirus vaccine (sars-cov-2, sars-cov, middle east respiratory syndrome [mers-cov]). - participation at the time of trial enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. - exclusion criterion for the supplemental cohort 1 and cohort 2 comparator group and for the 3 supplemental variant prime cohort 3 groups: positive rapid diagnostic test for sars-cov-2 antibodies at time of enrollment. - exclusion criterion for participants in supplemental cohort 2 who were primed as participant in the original phase ii cohort of the present study): receipt of authorized/conditionally approved covid-19 vaccine after enrollment in original phase 2 cohort. - exclusion criterion for all booster groups: documented virologically-confirmed sars-cov-2 infection (by naat) after first dose of primary immunization. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

- known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. - dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on investigator or designee's judgment. - self-reported thrombocytopenia, contraindicating intramuscular (im) vaccination based on investigator or designee's judgment. - bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating im vaccination based on investigator or designee's judgment. - unstable acute or chronic illness that in the opinion of the investigator or designee poses additional risk as a result of participation or that could interfere with the trial procedures. - receipt of solid-organ or bone marrow transplants in the past 180 days. - receipt of anti-cancer chemotherapy in the last 90 days. - moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°c [≥ 100.4°f]). a prospective participant should not be included in the trial until the condition has resolved or the febrile event has subsided. - receipt of any vaccine in the 30 days preceding or on the day of the first trial vaccination or planned receipt of any vaccine in the 30 days following the second trial vaccination except for influenza vaccination, which may be received at any time in relation to trial intervention. - prior administration of a coronavirus vaccine (sars-cov-2, sars-cov, middle east respiratory syndrome [mers-cov]). - participation at the time of trial enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

- known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. - dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on investigator or designee's judgment. - self-reported thrombocytopenia, contraindicating intramuscular (im) vaccination based on investigator or designee's judgment. - bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating im vaccination based on investigator or designee's judgment. - unstable acute or chronic illness that in the opinion of the investigator or designee poses additional risk as a result of participation or that could interfere with the trial procedures. - receipt of solid-organ or bone marrow transplants in the past 180 days. - receipt of anti-cancer chemotherapy in the last 90 days. - moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°c [≥ 100.4°f]). a prospective participant should not be included in the trial until the condition has resolved or the febrile event has subsided. - receipt of any vaccine in the 30 days preceding or on the day of the first trial vaccination or planned receipt of any vaccine in the 30 days following the second trial vaccination except for influenza vaccination, which may be received at any time in relation to trial intervention. - prior administration of a coronavirus vaccine (sars-cov-2, sars-cov, middle east respiratory syndrome [mers-cov]). - participation at the time of trial enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.