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

1. participant is pregnant or planning to become pregnant within 3 months after study vaccine administration. 2. history of allergy to any component of the vaccine or its excipients. 3. prior history of allergic or anaphylactic reaction after previous dose of a meningococcal capsular 12 polysaccharide-, diphtheria toxoid- or crm197-containing vaccine, or to any component of menactra. 4. significant infection (e.g., positive sars-cov-2 rt-pcr) or other acute illness, including fever \>100.4 °f (\>38.0 °c) within 2 weeks prior to administration of vaccine. 5. a medical or psychiatric condition that, according to the investigator's judgment, may pose additional risk as a result of participation, interfere with study assessments, interfere with interpretation of results or compromise participant safety. 6. participants with history of multisystemic-inflammatory syndrome in children (mis-c). 7. participated in an interventional clinical study within 28 days prior to day 1. 8. received any non-study vaccine within 28 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is permitted within 14 days before or after any dose of vaccine). 9. thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection. 10. severe and uncontrolled ongoing autoimmune or inflammatory disease, history of guillain-barre syndrome, or any other demyelinating condition prior/concomitant therapy: 11. receipt of immunoglobulin or another blood product within the 3 months before expected day of randomization (visit 1) in this study or those who expect to receive immunoglobulin or another blood product during this study, 12. immunosuppressive treatment during the course of the study (unless such treatment has to be administered in an emergency situation). note: specifically, treatment that can be expected to influence immune response. such treatment includes, but is not limited to, systemic or high dose inhaled (\>800 μg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs. use of inhaled (low dose), intranasal or topical steroids is permitted * glucocorticoids at a dose ≥20 mg/day of prednisone or equivalent given daily or on alternate days for ≥14 consecutive days between randomization and the participant´s schedule * other systemically administered drugs with significant immunosuppressive activity, such as azathioprine, tacrolimus, cyclosporine, methotrexate, or cytotoxic chemotherapy between randomization and the participant´s schedule 13. prior administration of an investigational or approved cov vaccine (such as, sars-cov-2, sars cov, middle east respiratory syndrome cov) or planned use during the trial. 14. treatment with investigational or approved agents for prophylaxis against covid 19 (such as, receipt of sars-cov-2 monoclonal antibodies or oral covid 19 anti-viral agents) within 6 months prior to enrolment. 15. receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine, within 28 days prior to the expected day of randomization (visit 1). others: 16. any member of the study team or sponsor. 17. an immediate family member or household member of the study's personnel.

1. participant is pregnant or planning to become pregnant within 3 months after study vaccine administration. 2. history of allergy to any component of the vaccine or its excipients. 3. prior history of allergic or anaphylactic reaction after previous dose of a meningococcal capsular 12 polysaccharide-, diphtheria toxoid- or crm197-containing vaccine, or to any component of menactra. 4. significant infection (e.g., positive sars-cov-2 rt-pcr) or other acute illness, including fever \>100.4 °f (\>38.0 °c) within 2 weeks prior to administration of vaccine. 5. a medical or psychiatric condition that, according to the investigator's judgment, may pose additional risk as a result of participation, interfere with study assessments, interfere with interpretation of results or compromise participant safety. 6. participants with history of multisystemic-inflammatory syndrome in children (mis-c). 7. participated in an interventional clinical study within 28 days prior to day 1. 8. received any non-study vaccine within 28 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is permitted within 14 days before or after any dose of vaccine). 9. thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection. 10. severe and uncontrolled ongoing autoimmune or inflammatory disease, history of guillain-barre syndrome, or any other demyelinating condition prior/concomitant therapy: 11. receipt of immunoglobulin or another blood product within the 3 months before expected day of randomization (visit 1) in this study or those who expect to receive immunoglobulin or another blood product during this study, 12. immunosuppressive treatment during the course of the study (unless such treatment has to be administered in an emergency situation). note: specifically, treatment that can be expected to influence immune response. such treatment includes, but is not limited to, systemic or high dose inhaled (\>800 μg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs. use of inhaled (low dose), intranasal or topical steroids is permitted * glucocorticoids at a dose ≥20 mg/day of prednisone or equivalent given daily or on alternate days for ≥14 consecutive days between randomization and the participant´s schedule * other systemically administered drugs with significant immunosuppressive activity, such as azathioprine, tacrolimus, cyclosporine, methotrexate, or cytotoxic chemotherapy between randomization and the participant´s schedule 13. prior administration of an investigational or approved cov vaccine (such as, sars-cov-2, sars cov, middle east respiratory syndrome cov) or planned use during the trial. 14. treatment with investigational or approved agents for prophylaxis against covid 19 (such as, receipt of sars-cov-2 monoclonal antibodies or oral covid 19 anti-viral agents) within 6 months prior to enrolment. 15. receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine, within 28 days prior to the expected day of randomization (visit 1). others: 16. any member of the study team or sponsor. 17. an immediate family member or household member of the study's personnel.

March 29, 2022, 2:30 p.m. usa

participant is pregnant or planning to become pregnant within 3 months after study vaccine administration. history of allergy to any component of the vaccine or its excipients. prior history of allergic or anaphylactic reaction after previous dose of a meningococcal capsular 12 polysaccharide-, diphtheria toxoid- or crm197-containing vaccine, or to any component of menactra. significant infection (e.g., positive sars-cov-2 rt-pcr) or other acute illness, including fever >100.4 °f (>38.0 °c) within 2 weeks prior to administration of vaccine. a medical or psychiatric condition that, according to the investigator's judgment, may pose additional risk as a result of participation, interfere with study assessments, interfere with interpretation of results or compromise participant safety. participants with history of multisystemic-inflammatory syndrome in children (mis-c). participated in an interventional clinical study within 28 days prior to day 1. received any non-study vaccine within 28 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is permitted within 14 days before or after any dose of vaccine). thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection. severe and uncontrolled ongoing autoimmune or inflammatory disease, history of guillain-barre syndrome, or any other demyelinating condition prior/concomitant therapy: receipt of immunoglobulin or another blood product within the 3 months before expected day of randomization (visit 1) in this study or those who expect to receive immunoglobulin or another blood product during this study, immunosuppressive treatment during the course of the study (unless such treatment has to be administered in an emergency situation). note: specifically, treatment that can be expected to influence immune response. such treatment includes, but is not limited to, systemic or high dose inhaled (>800 μg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs. use of inhaled (low dose), intranasal or topical steroids is permitted glucocorticoids at a dose ≥20 mg/day of prednisone or equivalent given daily or on alternate days for ≥14 consecutive days between randomization and the participant´s schedule other systemically administered drugs with significant immunosuppressive activity, such as azathioprine, tacrolimus, cyclosporine, methotrexate, or cytotoxic chemotherapy between randomization and the participant´s schedule prior administration of an investigational or approved cov vaccine (such as, sars-cov-2, sars cov, middle east respiratory syndrome cov) or planned use during the trial. treatment with investigational or approved agents for prophylaxis against covid 19 (such as, receipt of sars-cov-2 monoclonal antibodies or oral covid 19 anti-viral agents) within 6 months prior to enrolment. receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine, within 28 days prior to the expected day of randomization (visit 1). others: any member of the study team or sponsor. an immediate family member or household member of the study's personnel.

participant is pregnant or planning to become pregnant within 3 months after study vaccine administration. history of allergy to any component of the vaccine or its excipients. prior history of allergic or anaphylactic reaction after previous dose of a meningococcal capsular 12 polysaccharide-, diphtheria toxoid- or crm197-containing vaccine, or to any component of menactra. significant infection (e.g., positive sars-cov-2 rt-pcr) or other acute illness, including fever >100.4 °f (>38.0 °c) within 2 weeks prior to administration of vaccine. a medical or psychiatric condition that, according to the investigator's judgment, may pose additional risk as a result of participation, interfere with study assessments, interfere with interpretation of results or compromise participant safety. participants with history of multisystemic-inflammatory syndrome in children (mis-c). participated in an interventional clinical study within 28 days prior to day 1. received any non-study vaccine within 28 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is permitted within 14 days before or after any dose of vaccine). thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection. severe and uncontrolled ongoing autoimmune or inflammatory disease, history of guillain-barre syndrome, or any other demyelinating condition prior/concomitant therapy: receipt of immunoglobulin or another blood product within the 3 months before expected day of randomization (visit 1) in this study or those who expect to receive immunoglobulin or another blood product during this study, immunosuppressive treatment during the course of the study (unless such treatment has to be administered in an emergency situation). note: specifically, treatment that can be expected to influence immune response. such treatment includes, but is not limited to, systemic or high dose inhaled (>800 μg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs. use of inhaled (low dose), intranasal or topical steroids is permitted glucocorticoids at a dose ≥20 mg/day of prednisone or equivalent given daily or on alternate days for ≥14 consecutive days between randomization and the participant´s schedule other systemically administered drugs with significant immunosuppressive activity, such as azathioprine, tacrolimus, cyclosporine, methotrexate, or cytotoxic chemotherapy between randomization and the participant´s schedule prior administration of an investigational or approved cov vaccine (such as, sars-cov-2, sars cov, middle east respiratory syndrome cov) or planned use during the trial. treatment with investigational or approved agents for prophylaxis against covid 19 (such as, receipt of sars-cov-2 monoclonal antibodies or oral covid 19 anti-viral agents) within 6 months prior to enrolment. receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine, within 28 days prior to the expected day of randomization (visit 1). others: any member of the study team or sponsor. an immediate family member or household member of the study's personnel.