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

1. clinical and/or laboratory evidence indicative of covid-19 infection. 2. demonstrates a strong covid-19 positive antibody serology (\>12500 au/ml per chemiluminescent microparticle immunoassay (including advisedx sars-cov-2 igg ii)) or a negative covid-19 serology on screening against sars-cov-2 spike protein. 3. history of hypersensitivity to egg products. 4. history of severe reactions to vaccinations. 5. potential for prior ndv exposures (i.e., experience as a bird-handler, poultry farmer, or scientist conducting research with ndv). 6. history of an immunocompromising medical condition (such as primary immunodeficiencies, aids, or neutropenia). 7. current or recent use of immunosuppressive medications (i.e., any systemic corticosteroids, chemotherapeutics, immunoglobulin therapies, etc.) based on the assessment of their half-life by the investigator. 8. any history of hiv, hepatitis c, hepatitis b (by laboratory testing and/or history), guillain-barré syndrome, and/or recent receipt of immunoglobulins and/or blood products. 9. pregnancy or actively breastfeeding. 10. other medical condition or abnormal laboratory values which may place participant at increased risk for harm due to participation in the study as determined by the investigator. 11. in the opinion of the investigator that it would be unwise to allow the participant to be randomized into the study, including those persons who the investigator would consider as high risk of sars-cov-2 exposure, including healthcare workers with direct patient care and laboratory workers who handle sars-cov-2. 12. participants at higher risk of severe covid-19, as defined by cdc guidance (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html), where severity of risk and eligibility will be determined by the investigator. this guidance includes details regarding older adults, people with specific medical conditions, and pregnant and recently pregnant people. 13. participants with fever or signs of acute infection, including symptoms that could indicate sars-cov-2 infection. 14. participants with a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration. 15. participants who prepare food in the food industry and childcare workers who have direct contact with children 5 years of age or younger. 16. participants who have close or household high-risk contacts including but not limited to: * persons more than or equal to 65 years of age * children less than or equal to 5 years of age. * residents of nursing homes. * persons of any age with significant chronic medical conditions as well as immunosuppression or cancer. women who are pregnant, trying to become pregnant, or breastfeeding. 17. participants who are students, post-doctoral candidates, or trainees of the study site, or are members of the research staff. 18. participants with a history of myocarditis or pericarditis and individuals with an abnormal troponin or abnormal ecg as determined by the investigator. participants with a screening 12-lead ecg that shows an average qtc interval \>500 msec, complete left bundle branch block, st-t interval changes suggestive of myocardial ischemia, second- or third-degree av block, or serious bradyarrhythmias or tachyarrhythmias should be excluded from study participation.

1. clinical and/or laboratory evidence indicative of covid-19 infection. 2. demonstrates a strong covid-19 positive antibody serology (\>12500 au/ml per chemiluminescent microparticle immunoassay (including advisedx sars-cov-2 igg ii)) or a negative covid-19 serology on screening against sars-cov-2 spike protein. 3. history of hypersensitivity to egg products. 4. history of severe reactions to vaccinations. 5. potential for prior ndv exposures (i.e., experience as a bird-handler, poultry farmer, or scientist conducting research with ndv). 6. history of an immunocompromising medical condition (such as primary immunodeficiencies, aids, or neutropenia). 7. current or recent use of immunosuppressive medications (i.e., any systemic corticosteroids, chemotherapeutics, immunoglobulin therapies, etc.) based on the assessment of their half-life by the investigator. 8. any history of hiv, hepatitis c, hepatitis b (by laboratory testing and/or history), guillain-barré syndrome, and/or recent receipt of immunoglobulins and/or blood products. 9. pregnancy or actively breastfeeding. 10. other medical condition or abnormal laboratory values which may place participant at increased risk for harm due to participation in the study as determined by the investigator. 11. in the opinion of the investigator that it would be unwise to allow the participant to be randomized into the study, including those persons who the investigator would consider as high risk of sars-cov-2 exposure, including healthcare workers with direct patient care and laboratory workers who handle sars-cov-2. 12. participants at higher risk of severe covid-19, as defined by cdc guidance (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html), where severity of risk and eligibility will be determined by the investigator. this guidance includes details regarding older adults, people with specific medical conditions, and pregnant and recently pregnant people. 13. participants with fever or signs of acute infection, including symptoms that could indicate sars-cov-2 infection. 14. participants with a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration. 15. participants who prepare food in the food industry and childcare workers who have direct contact with children 5 years of age or younger. 16. participants who have close or household high-risk contacts including but not limited to: * persons more than or equal to 65 years of age * children less than or equal to 5 years of age. * residents of nursing homes. * persons of any age with significant chronic medical conditions as well as immunosuppression or cancer. women who are pregnant, trying to become pregnant, or breastfeeding. 17. participants who are students, post-doctoral candidates, or trainees of the study site, or are members of the research staff. 18. participants with a history of myocarditis or pericarditis and individuals with an abnormal troponin or abnormal ecg as determined by the investigator. participants with a screening 12-lead ecg that shows an average qtc interval \>500 msec, complete left bundle branch block, st-t interval changes suggestive of myocardial ischemia, second- or third-degree av block, or serious bradyarrhythmias or tachyarrhythmias should be excluded from study participation.

March 31, 2023, 4 a.m. usa

clinical and/or laboratory evidence indicative of covid-19 infection. demonstrates a strong covid-19 positive antibody serology (>12500 au/ml per chemiluminescent microparticle immunoassay (including advisedx sars-cov-2 igg ii)) or a negative covid-19 serology on screening against sars-cov-2 spike protein. history of hypersensitivity to egg products. history of severe reactions to vaccinations. potential for prior ndv exposures (i.e., experience as a bird-handler, poultry farmer, or scientist conducting research with ndv). history of an immunocompromising medical condition (such as primary immunodeficiencies, aids, or neutropenia). current or recent use of immunosuppressive medications (i.e., any systemic corticosteroids, chemotherapeutics, immunoglobulin therapies, etc.) based on the assessment of their half-life by the investigator. any history of hiv, hepatitis c, hepatitis b (by laboratory testing and/or history), guillain-barré syndrome, and/or recent receipt of immunoglobulins and/or blood products. pregnancy or actively breastfeeding. other medical condition or abnormal laboratory values which may place participant at increased risk for harm due to participation in the study as determined by the investigator. in the opinion of the investigator that it would be unwise to allow the participant to be randomized into the study, including those persons who the investigator would consider as high risk of sars-cov-2 exposure, including healthcare workers with direct patient care and laboratory workers who handle sars-cov-2. participants at higher risk of severe covid-19, as defined by cdc guidance (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html), where severity of risk and eligibility will be determined by the investigator. this guidance includes details regarding older adults, people with specific medical conditions, and pregnant and recently pregnant people. participants with fever or signs of acute infection, including symptoms that could indicate sars-cov-2 infection. participants with a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration. participants who prepare food in the food industry and childcare workers who have direct contact with children 5 years of age or younger. participants who have close or household high-risk contacts including but not limited to: persons more than or equal to 65 years of age children less than or equal to 5 years of age. residents of nursing homes. persons of any age with significant chronic medical conditions as well as immunosuppression or cancer. women who are pregnant, trying to become pregnant, or breastfeeding. participants who are students, post-doctoral candidates, or trainees of the study site, or are members of the research staff. participants with a history of myocarditis or pericarditis and individuals with an abnormal troponin or abnormal ecg as determined by the investigator. participants with a screening 12-lead ecg that shows an average qtc interval >500 msec, complete left bundle branch block, st-t interval changes suggestive of myocardial ischemia, second- or third-degree av block, or serious bradyarrhythmias or tachyarrhythmias should be excluded from study participation.

clinical and/or laboratory evidence indicative of covid-19 infection. demonstrates a strong covid-19 positive antibody serology (>12500 au/ml per chemiluminescent microparticle immunoassay (including advisedx sars-cov-2 igg ii)) or a negative covid-19 serology on screening against sars-cov-2 spike protein. history of hypersensitivity to egg products. history of severe reactions to vaccinations. potential for prior ndv exposures (i.e., experience as a bird-handler, poultry farmer, or scientist conducting research with ndv). history of an immunocompromising medical condition (such as primary immunodeficiencies, aids, or neutropenia). current or recent use of immunosuppressive medications (i.e., any systemic corticosteroids, chemotherapeutics, immunoglobulin therapies, etc.) based on the assessment of their half-life by the investigator. any history of hiv, hepatitis c, hepatitis b (by laboratory testing and/or history), guillain-barré syndrome, and/or recent receipt of immunoglobulins and/or blood products. pregnancy or actively breastfeeding. other medical condition or abnormal laboratory values which may place participant at increased risk for harm due to participation in the study as determined by the investigator. in the opinion of the investigator that it would be unwise to allow the participant to be randomized into the study, including those persons who the investigator would consider as high risk of sars-cov-2 exposure, including healthcare workers with direct patient care and laboratory workers who handle sars-cov-2. participants at higher risk of severe covid-19, as defined by cdc guidance (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html), where severity of risk and eligibility will be determined by the investigator. this guidance includes details regarding older adults, people with specific medical conditions, and pregnant and recently pregnant people. participants with fever or signs of acute infection, including symptoms that could indicate sars-cov-2 infection. participants with a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration. participants who prepare food in the food industry and childcare workers who have direct contact with children 5 years of age or younger. participants who have close or household high-risk contacts including but not limited to: persons more than or equal to 65 years of age children less than or equal to 5 years of age. residents of nursing homes. persons of any age with significant chronic medical conditions as well as immunosuppression or cancer. women who are pregnant, trying to become pregnant, or breastfeeding. participants who are students, post-doctoral candidates, or trainees of the study site, or are members of the research staff. participants with a history of myocarditis or pericarditis and individuals with an abnormal troponin or abnormal ecg as determined by the investigator. participants with a screening 12-lead ecg that shows an average qtc interval >500 msec, complete left bundle branch block, st-t interval changes suggestive of myocardial ischemia, second- or third-degree av block, or serious bradyarrhythmias or tachyarrhythmias should be excluded from study participation.

July 7, 2022, midnight usa

clinical and/or laboratory evidence indicative of covid-19 infection. demonstrates a strong covid-19 positive antibody serology (>12500 au/ml per chemiluminescent microparticle immunoassay (including advisedx sars-cov-2 igg ii)) or a negative covid-19 serology on screening against sars-cov-2 spike protein. history of hypersensitivity to egg products. history of severe reactions to vaccinations. potential for prior ndv exposures (i.e., experience as a bird-handler, poultry farmer, or scientist conducting research with ndv). history of an immunocompromising medical condition (such as primary immunodeficiencies, aids, or neutropenia). current or recent use of immunosuppressive medications (i.e. any systemic corticosteroids, chemotherapeutics, immunoglobulin therapies, etc.) based on the assessment of their half-life by the investigator. any history of hiv, hepatitis c, hepatitis b (by laboratory testing and/or history), guillain-barré syndrome, and/or recent receipt of immunoglobulins and/or blood products. pregnancy or actively breastfeeding. other medical condition which may place subject at increased risk for harm due to participation in the study as determined by the investigator. in the opinion of the investigator that it would be unwise to allow the participant to be randomized into the study, including those persons who the investigator would consider as high risk of sars-cov-2 exposure, including healthcare workers with direct patient care and laboratory workers who handle sars-cov-2. participants at higher risk of severe covid-19, as defined by cdc guidance (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html), where severity of risk and eligibility will be determined by the investigator. this guidance includes details regarding older adults, people with specific medical conditions, and pregnant and recently pregnant people. participants with fever or signs of acute infection, including symptoms that could indicate sars-cov-2 infection. participants with a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration. participants who prepare food in the food industry and childcare workers who have direct contact with children 5 years of age or younger. participants who have close or household high-risk contacts including but not limited to: persons more than or equal to 65 years of age children less than or equal to 5 years of age. residents of nursing homes. persons of any age with significant chronic medical conditions as well as immunosuppression or cancer. women who are pregnant, trying to become pregnant, or breastfeeding. participants who are students, post-doctoral candidates, or trainees of the study site, or are members of the research staff.

clinical and/or laboratory evidence indicative of covid-19 infection. demonstrates a strong covid-19 positive antibody serology (>12500 au/ml per chemiluminescent microparticle immunoassay (including advisedx sars-cov-2 igg ii)) or a negative covid-19 serology on screening against sars-cov-2 spike protein. history of hypersensitivity to egg products. history of severe reactions to vaccinations. potential for prior ndv exposures (i.e., experience as a bird-handler, poultry farmer, or scientist conducting research with ndv). history of an immunocompromising medical condition (such as primary immunodeficiencies, aids, or neutropenia). current or recent use of immunosuppressive medications (i.e. any systemic corticosteroids, chemotherapeutics, immunoglobulin therapies, etc.) based on the assessment of their half-life by the investigator. any history of hiv, hepatitis c, hepatitis b (by laboratory testing and/or history), guillain-barré syndrome, and/or recent receipt of immunoglobulins and/or blood products. pregnancy or actively breastfeeding. other medical condition which may place subject at increased risk for harm due to participation in the study as determined by the investigator. in the opinion of the investigator that it would be unwise to allow the participant to be randomized into the study, including those persons who the investigator would consider as high risk of sars-cov-2 exposure, including healthcare workers with direct patient care and laboratory workers who handle sars-cov-2. participants at higher risk of severe covid-19, as defined by cdc guidance (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html), where severity of risk and eligibility will be determined by the investigator. this guidance includes details regarding older adults, people with specific medical conditions, and pregnant and recently pregnant people. participants with fever or signs of acute infection, including symptoms that could indicate sars-cov-2 infection. participants with a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration. participants who prepare food in the food industry and childcare workers who have direct contact with children 5 years of age or younger. participants who have close or household high-risk contacts including but not limited to: persons more than or equal to 65 years of age children less than or equal to 5 years of age. residents of nursing homes. persons of any age with significant chronic medical conditions as well as immunosuppression or cancer. women who are pregnant, trying to become pregnant, or breastfeeding. participants who are students, post-doctoral candidates, or trainees of the study site, or are members of the research staff.

May 21, 2022, 9:30 a.m. usa

clinical and/or laboratory evidence indicative of covid-19 infection. demonstrates a strong covid-19 positive antibody serology (≥ 40 au/ml) or a negative covid-19 serology on screening against sars-cov-2 spike protein. history of hypersensitivity to egg products. history of severe reactions to vaccinations. potential for prior ndv exposures (i.e., experience as a bird-handler, poultry farmer, or scientist conducting research with ndv). history of an immunocompromising medical condition (such as primary immunodeficiencies, aids, or neutropenia). current or recent use of immunosuppressive medications (i.e. any systemic corticosteroids, chemotherapeutics, immunoglobulin therapies, etc.) based on the assessment of their half-life by the investigator. any history of hiv, hepatitis c, hepatitis b (by laboratory testing and/or history), guillain-barré syndrome, and/or recent receipt of immunoglobulins and/or blood products. pregnancy or actively breastfeeding. other medical condition which may place subject at increased risk for harm due to participation in the study as determined by the investigator. in the opinion of the investigator that it would be unwise to allow the participant to be randomized into the study, including those persons who the investigator would consider as high risk of sars-cov-2 exposure, including healthcare workers with direct patient care and laboratory workers who handle sars-cov-2. participants at higher risk of severe covid-19, as defined by cdc guidance (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html). this guidance includes details regarding older adults, people with specific medical conditions, and pregnant and recently pregnant people. participants with fever or signs of acute infection, including symptoms that could indicate sars-cov-2 infection. participants with a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration. participants who prepare food in the food industry and childcare workers who have direct contact with children 5 years of age or younger. participants who have close or household high-risk contacts including but not limited to: persons more than or equal to 65 years of age children less than or equal to 5 years of age. residents of nursing homes. persons of any age with significant chronic medical conditions as well as immunosuppression or cancer. women who are pregnant, trying to become pregnant, or breastfeeding. participants who are students, post-doctoral candidates, or trainees of the study site, or are members of the research staff.

clinical and/or laboratory evidence indicative of covid-19 infection. demonstrates a strong covid-19 positive antibody serology (≥ 40 au/ml) or a negative covid-19 serology on screening against sars-cov-2 spike protein. history of hypersensitivity to egg products. history of severe reactions to vaccinations. potential for prior ndv exposures (i.e., experience as a bird-handler, poultry farmer, or scientist conducting research with ndv). history of an immunocompromising medical condition (such as primary immunodeficiencies, aids, or neutropenia). current or recent use of immunosuppressive medications (i.e. any systemic corticosteroids, chemotherapeutics, immunoglobulin therapies, etc.) based on the assessment of their half-life by the investigator. any history of hiv, hepatitis c, hepatitis b (by laboratory testing and/or history), guillain-barré syndrome, and/or recent receipt of immunoglobulins and/or blood products. pregnancy or actively breastfeeding. other medical condition which may place subject at increased risk for harm due to participation in the study as determined by the investigator. in the opinion of the investigator that it would be unwise to allow the participant to be randomized into the study, including those persons who the investigator would consider as high risk of sars-cov-2 exposure, including healthcare workers with direct patient care and laboratory workers who handle sars-cov-2. participants at higher risk of severe covid-19, as defined by cdc guidance (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html). this guidance includes details regarding older adults, people with specific medical conditions, and pregnant and recently pregnant people. participants with fever or signs of acute infection, including symptoms that could indicate sars-cov-2 infection. participants with a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration. participants who prepare food in the food industry and childcare workers who have direct contact with children 5 years of age or younger. participants who have close or household high-risk contacts including but not limited to: persons more than or equal to 65 years of age children less than or equal to 5 years of age. residents of nursing homes. persons of any age with significant chronic medical conditions as well as immunosuppression or cancer. women who are pregnant, trying to become pregnant, or breastfeeding. participants who are students, post-doctoral candidates, or trainees of the study site, or are members of the research staff.

Jan. 8, 2022, 8 a.m. usa

clinical and/or laboratory evidence indicative of covid-19 infection. demonstrates a strong covid-19 positive antibody serology (≥ 40 au/ml) or a negative covid-19 serology on screening. history of hypersensitivity to egg products. history of severe reactions to vaccinations. potential for prior ndv exposures (i.e., experience as a bird-handler, poultry farmer, or scientist conducting research with ndv). history of an immunocompromising medical condition (such as primary immunodeficiencies, aids, or neutropenia). current or recent use of immunosuppressive medications (i.e. any systemic corticosteroids, chemotherapeutics, immunoglobulin therapies, etc.) based on the assessment of their half-life by the investigator. any history of hiv, hepatitis c, hepatitis b (by laboratory testing and/or history), guillain-barré syndrome, and/or recent receipt of immunoglobulins and/or blood products. pregnancy or actively breastfeeding. other medical condition which may place subject at increased risk for harm due to participation in the study as determined by the investigator. in the opinion of the investigator that it would be unwise to allow the participant to be randomized into the study, including those persons who the investigator would consider as high risk of sars-cov-2 exposure, including healthcare workers with direct patient care and laboratory workers who handle sars-cov-2. participants at higher risk of severe covid-19, as defined by cdc guidance (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html). this guidance includes details regarding older adults, people with specific medical conditions, and pregnant and recently pregnant people. participants with fever or signs of acute infection, including symptoms that could indicate sars-cov-2 infection. participants with a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration. participants who prepare food in the food industry and childcare workers who have direct contact with children 5 years of age or younger. participants who have close or household high-risk contacts including but not limited to: persons more than or equal to 65 years of age children less than or equal to 5 years of age. residents of nursing homes. persons of any age with significant chronic medical conditions as well as immunosuppression or cancer. women who are pregnant, trying to become pregnant, or breastfeeding. participants who are students, post-doctoral candidates, or trainees of the study site, or are members of the research staff.

clinical and/or laboratory evidence indicative of covid-19 infection. demonstrates a strong covid-19 positive antibody serology (≥ 40 au/ml) or a negative covid-19 serology on screening. history of hypersensitivity to egg products. history of severe reactions to vaccinations. potential for prior ndv exposures (i.e., experience as a bird-handler, poultry farmer, or scientist conducting research with ndv). history of an immunocompromising medical condition (such as primary immunodeficiencies, aids, or neutropenia). current or recent use of immunosuppressive medications (i.e. any systemic corticosteroids, chemotherapeutics, immunoglobulin therapies, etc.) based on the assessment of their half-life by the investigator. any history of hiv, hepatitis c, hepatitis b (by laboratory testing and/or history), guillain-barré syndrome, and/or recent receipt of immunoglobulins and/or blood products. pregnancy or actively breastfeeding. other medical condition which may place subject at increased risk for harm due to participation in the study as determined by the investigator. in the opinion of the investigator that it would be unwise to allow the participant to be randomized into the study, including those persons who the investigator would consider as high risk of sars-cov-2 exposure, including healthcare workers with direct patient care and laboratory workers who handle sars-cov-2. participants at higher risk of severe covid-19, as defined by cdc guidance (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html). this guidance includes details regarding older adults, people with specific medical conditions, and pregnant and recently pregnant people. participants with fever or signs of acute infection, including symptoms that could indicate sars-cov-2 infection. participants with a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration. participants who prepare food in the food industry and childcare workers who have direct contact with children 5 years of age or younger. participants who have close or household high-risk contacts including but not limited to: persons more than or equal to 65 years of age children less than or equal to 5 years of age. residents of nursing homes. persons of any age with significant chronic medical conditions as well as immunosuppression or cancer. women who are pregnant, trying to become pregnant, or breastfeeding. participants who are students, post-doctoral candidates, or trainees of the study site, or are members of the research staff.