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

1. participant is ill or febrile (body temperature ≥ 38.0°c) within 72 prior hours or and/or symptoms suggestive of covid-19 or being contact subject within the past 14 days at enrolment visit. (ill or febrile participants may be re-scheduled within the trial inclusion period when no longer presenting symptoms, except if condition is covid19) 2. participants with positive pcr, antigenic test or chest tdm or serology to sars-cov-2 at the enrolment visit, only for the group1. 3. participants who already received another anti-sars-cov-2-vaccine 4. participants who received bcg given within the last year. 5. use of immunosuppressive drugs like e.g. corticosteroids at a dosage \> 10mg equivalent prednisone /day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies 6. received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion. 7. received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine within 4 weeks after the last injection. 8. history of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, laryngeal oedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-sars-cov-2-vaccine. 9. history of severe allergic event 10. known hiv, active hcv or hbv infection 11. any pathological condition, such as cancer, which may be susceptible of reducing immunity response 12. any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy 13. the use of investigational ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study 14. any condition which in the opinion of the investigator may interfere with the aim of the study 15. pregnant or breastfeeding or positive pregnancy blood test at enrolment visit. 16. an immediate family member or household member of study staff. 17. participation in another investigational clinical study (jardé 1 or jardé 2) within 4 weeks before the enrolment visit or still in an exclusion period from another clinical trial or participation in another investigational clinical study planned before the study completion. 18. people under legal protection measure (tutorship, curatorship or safeguard measures)

1. participant is ill or febrile (body temperature ≥ 38.0°c) within 72 prior hours or and/or symptoms suggestive of covid-19 or being contact subject within the past 14 days at enrolment visit. (ill or febrile participants may be re-scheduled within the trial inclusion period when no longer presenting symptoms, except if condition is covid19) 2. participants with positive pcr, antigenic test or chest tdm or serology to sars-cov-2 at the enrolment visit, only for the group1. 3. participants who already received another anti-sars-cov-2-vaccine 4. participants who received bcg given within the last year. 5. use of immunosuppressive drugs like e.g. corticosteroids at a dosage \> 10mg equivalent prednisone /day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies 6. received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion. 7. received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine within 4 weeks after the last injection. 8. history of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, laryngeal oedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-sars-cov-2-vaccine. 9. history of severe allergic event 10. known hiv, active hcv or hbv infection 11. any pathological condition, such as cancer, which may be susceptible of reducing immunity response 12. any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy 13. the use of investigational ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study 14. any condition which in the opinion of the investigator may interfere with the aim of the study 15. pregnant or breastfeeding or positive pregnancy blood test at enrolment visit. 16. an immediate family member or household member of study staff. 17. participation in another investigational clinical study (jardé 1 or jardé 2) within 4 weeks before the enrolment visit or still in an exclusion period from another clinical trial or participation in another investigational clinical study planned before the study completion. 18. people under legal protection measure (tutorship, curatorship or safeguard measures)

Nov. 16, 2021, 6:30 p.m. usa

participant is ill or febrile (body temperature ≥ 38.0°c) within 72 prior hours or and/or symptoms suggestive of covid-19 or being contact subject within the past 14 days at enrolment visit. (ill or febrile participants may be re-scheduled within the trial inclusion period when no longer presenting symptoms, except if condition is covid19) participants with positive pcr, antigenic test or chest tdm or serology to sars-cov-2 at the enrolment visit, only for the group1. participants who already received another anti-sars-cov-2-vaccine participants who received bcg given within the last year. use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg equivalent prednisone /day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion. received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine within 4 weeks after the last injection. history of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, laryngeal oedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-sars-cov-2-vaccine. history of severe allergic event known hiv, active hcv or hbv infection any pathological condition, such as cancer, which may be susceptible of reducing immunity response any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy the use of investigational ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study any condition which in the opinion of the investigator may interfere with the aim of the study pregnant or breastfeeding or positive pregnancy blood test at enrolment visit. an immediate family member or household member of study staff. participation in another investigational clinical study (jardé 1 or jardé 2) within 4 weeks before the enrolment visit or still in an exclusion period from another clinical trial or participation in another investigational clinical study planned before the study completion. people under legal protection measure (tutorship, curatorship or safeguard measures)

participant is ill or febrile (body temperature ≥ 38.0°c) within 72 prior hours or and/or symptoms suggestive of covid-19 or being contact subject within the past 14 days at enrolment visit. (ill or febrile participants may be re-scheduled within the trial inclusion period when no longer presenting symptoms, except if condition is covid19) participants with positive pcr, antigenic test or chest tdm or serology to sars-cov-2 at the enrolment visit, only for the group1. participants who already received another anti-sars-cov-2-vaccine participants who received bcg given within the last year. use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg equivalent prednisone /day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion. received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine within 4 weeks after the last injection. history of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, laryngeal oedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-sars-cov-2-vaccine. history of severe allergic event known hiv, active hcv or hbv infection any pathological condition, such as cancer, which may be susceptible of reducing immunity response any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy the use of investigational ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study any condition which in the opinion of the investigator may interfere with the aim of the study pregnant or breastfeeding or positive pregnancy blood test at enrolment visit. an immediate family member or household member of study staff. participation in another investigational clinical study (jardé 1 or jardé 2) within 4 weeks before the enrolment visit or still in an exclusion period from another clinical trial or participation in another investigational clinical study planned before the study completion. people under legal protection measure (tutorship, curatorship or safeguard measures)

Aug. 10, 2021, 3:30 p.m. usa

1. participant is ill or febrile (body temperature ≥ 38.0°c) within 72 prior hours or and/or symptoms suggestive of covid-19 or being contact subject within the past 14 days at enrolment visit. (ill or febrile participants may be re-scheduled within the trial inclusion period when no longer presenting symptoms, except if condition is covid19) 2. participants with positive pcr, antigenic test or chest tdm or serology to sars-cov-2 at the enrolment visit, only for the group1. 3. participants who already received another anti-sars-cov-2-vaccine 4. participants who received bcg given within the last year. 5. use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg equivalent prednisone /day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies 6. received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion. 7. received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine within 4 weeks after the last injection. 8. history of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, laryngeal oedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-sars-cov-2-vaccine. 9. history of severe allergic event 10. known hiv, active hcv or hbv infection 11. any pathological condition, such as cancer, which may be susceptible of reducing immunity response 12. any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy 13. the use of investigational ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study 14. any condition which in the opinion of the investigator may interfere with the aim of the study 15. pregnant or breastfeeding or positive pregnancy blood test at enrolment visit. 16. an immediate family member or household member of study staff. 17. participation in another investigational clinical study (jardé 1 or jardé 2) within 4 weeks before the enrolment visit or still in an exclusion period from another clinical trial or participation in another investigational clinical study planned before the study completion. 18. people under legal protection measure (tutorship, curatorship or safeguard measures)

1. participant is ill or febrile (body temperature ≥ 38.0°c) within 72 prior hours or and/or symptoms suggestive of covid-19 or being contact subject within the past 14 days at enrolment visit. (ill or febrile participants may be re-scheduled within the trial inclusion period when no longer presenting symptoms, except if condition is covid19) 2. participants with positive pcr, antigenic test or chest tdm or serology to sars-cov-2 at the enrolment visit, only for the group1. 3. participants who already received another anti-sars-cov-2-vaccine 4. participants who received bcg given within the last year. 5. use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg equivalent prednisone /day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies 6. received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion. 7. received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine within 4 weeks after the last injection. 8. history of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, laryngeal oedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-sars-cov-2-vaccine. 9. history of severe allergic event 10. known hiv, active hcv or hbv infection 11. any pathological condition, such as cancer, which may be susceptible of reducing immunity response 12. any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy 13. the use of investigational ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study 14. any condition which in the opinion of the investigator may interfere with the aim of the study 15. pregnant or breastfeeding or positive pregnancy blood test at enrolment visit. 16. an immediate family member or household member of study staff. 17. participation in another investigational clinical study (jardé 1 or jardé 2) within 4 weeks before the enrolment visit or still in an exclusion period from another clinical trial or participation in another investigational clinical study planned before the study completion. 18. people under legal protection measure (tutorship, curatorship or safeguard measures)

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

1. participant is ill or febrile (body temperature ≥ 38.0°c) within 72 prior hours or and/or symptoms suggestive of covid-19 or being contact subject within the past 14 days at enrolment visit. (ill or febrile participants may be re-scheduled within the trial inclusion period when no longer presenting symptoms, except if condition is covid19) 2. participants with positive pcr, antigenic test or chest tdm or serology to sars-cov-2 at the enrolment visit, only for the group1. 3. participants who already received another anti-sars-cov-2-vaccine 4. participants who received bcg given within the last year. 5. use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg equivalent prednisone /day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies 6. received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion. 7. received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine 4 weeks after the last injection. 8. history of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, laryngeal oedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-sars-cov-2-vaccine. 9. history of severe allergic event 10. known hiv, active hcv or hbv infection 11. any pathological condition, such as cancer, which may be susceptible of reducing immunity response 12. any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy 13. the use of investigational ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study 14. any condition which in the opinion of the investigator may interfere with the aim of the study 15. pregnant or breastfeeding or positive pregnancy blood test at enrolment visit. 16. an immediate family member or household member of study staff. 17. participation in another investigational clinical study (jardé 1 or jardé 2) within 4 weeks before the enrolment visit or still in an exclusion period from another clinical trial or participation in another investigational clinical study planned before the study completion. 18. people under legal protection measure (tutorship, curatorship or safeguard measures)

1. participant is ill or febrile (body temperature ≥ 38.0°c) within 72 prior hours or and/or symptoms suggestive of covid-19 or being contact subject within the past 14 days at enrolment visit. (ill or febrile participants may be re-scheduled within the trial inclusion period when no longer presenting symptoms, except if condition is covid19) 2. participants with positive pcr, antigenic test or chest tdm or serology to sars-cov-2 at the enrolment visit, only for the group1. 3. participants who already received another anti-sars-cov-2-vaccine 4. participants who received bcg given within the last year. 5. use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg equivalent prednisone /day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies 6. received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion. 7. received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine 4 weeks after the last injection. 8. history of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, laryngeal oedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-sars-cov-2-vaccine. 9. history of severe allergic event 10. known hiv, active hcv or hbv infection 11. any pathological condition, such as cancer, which may be susceptible of reducing immunity response 12. any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy 13. the use of investigational ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study 14. any condition which in the opinion of the investigator may interfere with the aim of the study 15. pregnant or breastfeeding or positive pregnancy blood test at enrolment visit. 16. an immediate family member or household member of study staff. 17. participation in another investigational clinical study (jardé 1 or jardé 2) within 4 weeks before the enrolment visit or still in an exclusion period from another clinical trial or participation in another investigational clinical study planned before the study completion. 18. people under legal protection measure (tutorship, curatorship or safeguard measures)