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

inclusion criteria: 1. capable of giving signed informed consent as described in appendix a which includes compliance with the requirements and restrictions listed in the icf and in this protocol. for pediatric participants: informed assent is to be provided by the participant; informed consent must be provided by the participant's legal guardian 2. ensure that participants who are considered by the investigator clinically unable to consent at screening and who are entered into the study by the consent of a legally acceptable representative show evidence of assent, as applicable in accordance with local regulations. 3. participant must be an adult (≥ 18 years of age) or pediatric individual (≥ 12 to \< 18 years of age weighing ≥ 40 kg) at the time of signing the icf or assent (for pediatric participants). 4. individuals with medical conditions or treatments that may result in moderate to severe immune compromise or an inadequate immune response to covid-19 vaccination include but are not limited to: 1. active treatment for solid tumor and hematologic malignancies. 2. receipt of solid-organ transplant and taking immunosuppressive therapy. 3. receipt of chimeric antigen receptor t-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy). 4. moderate or severe primary immunodeficiency (eg, digeorge syndrome, wiskott-aldrich syndrome). 5. advanced or untreated hiv infection (people with hiv and history of cd4 cellcounts \< 200/mm3, history of an aids-defining illness without immune reconstitution, or clinical manifestations of symptomatic hiv). 6. active treatment with systemic high-dose corticosteroids (ie, ≥ 20 mg prednisone or equivalent per day when administered for ≥ 2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor blockers, and other biologic agents that are immunosuppressive or immunomodulatory (eg, b-cell depleting agents). 5 documented negative sars-cov-2 rt-pcr test from an np specimen collected ≤ 3 days prior to day 1 or a negative sars-cov-2 rapid antigen test from an np specimen at screening.

inclusion criteria: 1. capable of giving signed informed consent as described in appendix a which includes compliance with the requirements and restrictions listed in the icf and in this protocol. for pediatric participants: informed assent is to be provided by the participant; informed consent must be provided by the participant's legal guardian 2. ensure that participants who are considered by the investigator clinically unable to consent at screening and who are entered into the study by the consent of a legally acceptable representative show evidence of assent, as applicable in accordance with local regulations. 3. participant must be an adult (≥ 18 years of age) or pediatric individual (≥ 12 to \< 18 years of age weighing ≥ 40 kg) at the time of signing the icf or assent (for pediatric participants). 4. individuals with medical conditions or treatments that may result in moderate to severe immune compromise or an inadequate immune response to covid-19 vaccination include but are not limited to: 1. active treatment for solid tumor and hematologic malignancies. 2. receipt of solid-organ transplant and taking immunosuppressive therapy. 3. receipt of chimeric antigen receptor t-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy). 4. moderate or severe primary immunodeficiency (eg, digeorge syndrome, wiskott-aldrich syndrome). 5. advanced or untreated hiv infection (people with hiv and history of cd4 cellcounts \< 200/mm3, history of an aids-defining illness without immune reconstitution, or clinical manifestations of symptomatic hiv). 6. active treatment with systemic high-dose corticosteroids (ie, ≥ 20 mg prednisone or equivalent per day when administered for ≥ 2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor blockers, and other biologic agents that are immunosuppressive or immunomodulatory (eg, b-cell depleting agents). 5 documented negative sars-cov-2 rt-pcr test from an np specimen collected ≤ 3 days prior to day 1 or a negative sars-cov-2 rapid antigen test from an np specimen at screening.

March 1, 2023, 9:56 a.m. usa

inclusion criteria: 1. capable of giving signed informed consent as described in appendix a which includes compliance with the requirements and restrictions listed in the icf and in this protocol. for pediatric participants: informed assent is to be provided by the participant; informed consent must be provided by the participant's legal guardian 2. ensure that participants who are considered by the investigator clinically unable to consent at screening and who are entered into the study by the consent of a legally acceptable representative show evidence of assent, as applicable in accordance with local regulations. 3. participant must be an adult (≥ 18 years of age) or pediatric individual (≥ 12 to < 18 years of age weighing ≥ 40 kg) at the time of signing the icf or assent (for pediatric participants). 4. individuals with medical conditions or treatments that may result in moderate to severe immune compromise or an inadequate immune response to covid-19 vaccination include but are not limited to: active treatment for solid tumor and hematologic malignancies. receipt of solid-organ transplant and taking immunosuppressive therapy. receipt of chimeric antigen receptor t-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy). moderate or severe primary immunodeficiency (eg, digeorge syndrome, wiskott-aldrich syndrome). advanced or untreated hiv infection (people with hiv and history of cd4 cellcounts < 200/mm3, history of an aids-defining illness without immune reconstitution, or clinical manifestations of symptomatic hiv). active treatment with systemic high-dose corticosteroids (ie, ≥ 20 mg prednisone or equivalent per day when administered for ≥ 2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor blockers, and other biologic agents that are immunosuppressive or immunomodulatory (eg, b-cell depleting agents). 5 documented negative sars-cov-2 rt-pcr test from an np specimen collected ≤ 3 days prior to day 1 or a negative sars-cov-2 rapid antigen test from an np specimen at screening.

inclusion criteria: 1. capable of giving signed informed consent as described in appendix a which includes compliance with the requirements and restrictions listed in the icf and in this protocol. for pediatric participants: informed assent is to be provided by the participant; informed consent must be provided by the participant's legal guardian 2. ensure that participants who are considered by the investigator clinically unable to consent at screening and who are entered into the study by the consent of a legally acceptable representative show evidence of assent, as applicable in accordance with local regulations. 3. participant must be an adult (≥ 18 years of age) or pediatric individual (≥ 12 to < 18 years of age weighing ≥ 40 kg) at the time of signing the icf or assent (for pediatric participants). 4. individuals with medical conditions or treatments that may result in moderate to severe immune compromise or an inadequate immune response to covid-19 vaccination include but are not limited to: active treatment for solid tumor and hematologic malignancies. receipt of solid-organ transplant and taking immunosuppressive therapy. receipt of chimeric antigen receptor t-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy). moderate or severe primary immunodeficiency (eg, digeorge syndrome, wiskott-aldrich syndrome). advanced or untreated hiv infection (people with hiv and history of cd4 cellcounts < 200/mm3, history of an aids-defining illness without immune reconstitution, or clinical manifestations of symptomatic hiv). active treatment with systemic high-dose corticosteroids (ie, ≥ 20 mg prednisone or equivalent per day when administered for ≥ 2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor blockers, and other biologic agents that are immunosuppressive or immunomodulatory (eg, b-cell depleting agents). 5 documented negative sars-cov-2 rt-pcr test from an np specimen collected ≤ 3 days prior to day 1 or a negative sars-cov-2 rapid antigen test from an np specimen at screening.

May 19, 2022, 8:39 a.m. usa

inclusion criteria: capable of giving signed informed consent as described in appendix a which includes compliance with the requirements and restrictions listed in the icf and in this protocol. for pediatric participants: informed assent is to be provided by the participant; informed consent must be provided by the participant's legal guardian ensure that participants who are considered by the investigator clinically unable to consent at screening and who are entered into the study by the consent of a legally acceptable representative show evidence of assent, as applicable in accordance with local regulations. participant must be an adult (≥ 18 years of age) or pediatric individual (≥ 12 to < 18 years of age weighing ≥ 40 kg) at the time of signing the icf or assent (for pediatric participants).

inclusion criteria: capable of giving signed informed consent as described in appendix a which includes compliance with the requirements and restrictions listed in the icf and in this protocol. for pediatric participants: informed assent is to be provided by the participant; informed consent must be provided by the participant's legal guardian ensure that participants who are considered by the investigator clinically unable to consent at screening and who are entered into the study by the consent of a legally acceptable representative show evidence of assent, as applicable in accordance with local regulations. participant must be an adult (≥ 18 years of age) or pediatric individual (≥ 12 to < 18 years of age weighing ≥ 40 kg) at the time of signing the icf or assent (for pediatric participants).