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

inclusion criteria: 1. male or female participants who are ≥2 years of age at the time of enrollment (visit 1). 2. participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3. life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (visit 1). 4. participants or participant's parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period. 5. female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. 6. participants who are immunocompromised by virtue of the following: * having known non-small cell lung cancer (nsclc) and is ≥18 years of age with at least 1 of the following: * who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or * receiving checkpoint inhibitor treatment (programmed cell death protein 1 (pd-1)/ programmed death-ligand 1 (pd-l1) inhibitor, cytotoxic t-lymphocyte-associated protein 4 (ctla-4) inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or * receiving targeted drug therapy treatment (epidermal growth factor receptor (egfr), anaplastic lymphoma kinase (alk), proto-oncogene tyrosine-protein kinase (ros1), v-raf murine sarcoma viral oncogene homolog b1 (braf),rearranged during transfection (ret),hepatocyte growth factor receptor (met), neurotrophic tyrosine kinase (ntrk) inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or * having known chronic lymphocytic leukemia (cll) and is ≥18 years of age with at least 1 of the following: * has asymptomatic disease (eg, rai stage \<3, binet stage a or b) and is undergoing observation and does not receive any treatment for cll; or * receiving b-cell inhibitory monoclonal antibody treatment (anti-cd20) and has received at least 3 cycles prior to enrollment; and/or * receives a bruton tyrosine kinase (btk) inhibitor, phosphoinositide 3-kinase (pi3k) inhibitor, or b-cell lymphoma-2 (bcl-2) inhibitor; or * is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age; or * is on active immunomodulator therapy (eg, tumor necrosis factor alpha (tnfα) inhibitor, or tofacitinib or methotrexate) for an autoimmune or inflammatory disease disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel disease, such as ulcerative colitis and crohn's disease) at a stable\* dose \*stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to visit 1; or * receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (visit 1), and is ≥2 to \<18 years of age; or * has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to \<18 years of age 7. the participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), which includes compliance with the requirements and restrictions listed in the icd and in this protocol. the investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian before any study-specific activity is performed. all parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. the investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

inclusion criteria: 1. male or female participants who are ≥2 years of age at the time of enrollment (visit 1). 2. participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3. life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (visit 1). 4. participants or participant's parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period. 5. female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. 6. participants who are immunocompromised by virtue of the following: * having known non-small cell lung cancer (nsclc) and is ≥18 years of age with at least 1 of the following: * who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or * receiving checkpoint inhibitor treatment (programmed cell death protein 1 (pd-1)/ programmed death-ligand 1 (pd-l1) inhibitor, cytotoxic t-lymphocyte-associated protein 4 (ctla-4) inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or * receiving targeted drug therapy treatment (epidermal growth factor receptor (egfr), anaplastic lymphoma kinase (alk), proto-oncogene tyrosine-protein kinase (ros1), v-raf murine sarcoma viral oncogene homolog b1 (braf),rearranged during transfection (ret),hepatocyte growth factor receptor (met), neurotrophic tyrosine kinase (ntrk) inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or * having known chronic lymphocytic leukemia (cll) and is ≥18 years of age with at least 1 of the following: * has asymptomatic disease (eg, rai stage \<3, binet stage a or b) and is undergoing observation and does not receive any treatment for cll; or * receiving b-cell inhibitory monoclonal antibody treatment (anti-cd20) and has received at least 3 cycles prior to enrollment; and/or * receives a bruton tyrosine kinase (btk) inhibitor, phosphoinositide 3-kinase (pi3k) inhibitor, or b-cell lymphoma-2 (bcl-2) inhibitor; or * is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age; or * is on active immunomodulator therapy (eg, tumor necrosis factor alpha (tnfα) inhibitor, or tofacitinib or methotrexate) for an autoimmune or inflammatory disease disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel disease, such as ulcerative colitis and crohn's disease) at a stable\* dose \*stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to visit 1; or * receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (visit 1), and is ≥2 to \<18 years of age; or * has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to \<18 years of age 7. the participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), which includes compliance with the requirements and restrictions listed in the icd and in this protocol. the investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian before any study-specific activity is performed. all parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. the investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

Aug. 31, 2023, noon usa

inclusion criteria: male or female participants who are ≥2 years of age at the time of enrollment (visit 1). participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (visit 1). participants or participant's parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period. female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. participants who are immunocompromised by virtue of the following: having known non-small cell lung cancer (nsclc) and is ≥18 years of age with at least 1 of the following: who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or receiving checkpoint inhibitor treatment (programmed cell death protein 1 (pd-1)/ programmed death-ligand 1 (pd-l1) inhibitor, cytotoxic t-lymphocyte-associated protein 4 (ctla-4) inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or receiving targeted drug therapy treatment (epidermal growth factor receptor (egfr), anaplastic lymphoma kinase (alk), proto-oncogene tyrosine-protein kinase (ros1), v-raf murine sarcoma viral oncogene homolog b1 (braf),rearranged during transfection (ret),hepatocyte growth factor receptor (met), neurotrophic tyrosine kinase (ntrk) inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or having known chronic lymphocytic leukemia (cll) and is ≥18 years of age with at least 1 of the following: has asymptomatic disease (eg, rai stage <3, binet stage a or b) and is undergoing observation and does not receive any treatment for cll; or receiving b-cell inhibitory monoclonal antibody treatment (anti-cd20) and has received at least 3 cycles prior to enrollment; and/or receives a bruton tyrosine kinase (btk) inhibitor, phosphoinositide 3-kinase (pi3k) inhibitor, or b-cell lymphoma-2 (bcl-2) inhibitor; or is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age; or is on active immunomodulator therapy (eg, tumor necrosis factor alpha (tnfα) inhibitor, or tofacitinib or methotrexate) for an autoimmune or inflammatory disease disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel disease, such as ulcerative colitis and crohn's disease) at a stable* dose *stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to visit 1; or receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (visit 1), and is ≥2 to <18 years of age; or has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to <18 years of age the participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), which includes compliance with the requirements and restrictions listed in the icd and in this protocol. the investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian before any study-specific activity is performed. all parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. the investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

inclusion criteria: male or female participants who are ≥2 years of age at the time of enrollment (visit 1). participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (visit 1). participants or participant's parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period. female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. participants who are immunocompromised by virtue of the following: having known non-small cell lung cancer (nsclc) and is ≥18 years of age with at least 1 of the following: who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or receiving checkpoint inhibitor treatment (programmed cell death protein 1 (pd-1)/ programmed death-ligand 1 (pd-l1) inhibitor, cytotoxic t-lymphocyte-associated protein 4 (ctla-4) inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or receiving targeted drug therapy treatment (epidermal growth factor receptor (egfr), anaplastic lymphoma kinase (alk), proto-oncogene tyrosine-protein kinase (ros1), v-raf murine sarcoma viral oncogene homolog b1 (braf),rearranged during transfection (ret),hepatocyte growth factor receptor (met), neurotrophic tyrosine kinase (ntrk) inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or having known chronic lymphocytic leukemia (cll) and is ≥18 years of age with at least 1 of the following: has asymptomatic disease (eg, rai stage <3, binet stage a or b) and is undergoing observation and does not receive any treatment for cll; or receiving b-cell inhibitory monoclonal antibody treatment (anti-cd20) and has received at least 3 cycles prior to enrollment; and/or receives a bruton tyrosine kinase (btk) inhibitor, phosphoinositide 3-kinase (pi3k) inhibitor, or b-cell lymphoma-2 (bcl-2) inhibitor; or is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age; or is on active immunomodulator therapy (eg, tumor necrosis factor alpha (tnfα) inhibitor, or tofacitinib or methotrexate) for an autoimmune or inflammatory disease disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel disease, such as ulcerative colitis and crohn's disease) at a stable* dose *stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to visit 1; or receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (visit 1), and is ≥2 to <18 years of age; or has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to <18 years of age the participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), which includes compliance with the requirements and restrictions listed in the icd and in this protocol. the investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian before any study-specific activity is performed. all parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. the investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

May 2, 2023, 8 p.m. usa

inclusion criteria: male or female participants who are ≥2 years of age at the time of enrollment (visit 1). participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (visit 1). participants or participant's parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period. female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. participants who are immunocompromised by virtue of the following: having known nsclc and is ≥18 years of age with at least 1 of the following: who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or receiving checkpoint inhibitor treatment (pd-1/pd-l1 inhibitor, ctla-4 inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or receiving targeted drug therapy treatment (egfr, alk, ros1, braf, ret, met, ntrk inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or having known cll and is ≥18 years of age with at least 1 of the following: has asymptomatic disease (eg, rai stage <3, binet stage a or b) and is undergoing observation and does not receive any treatment for cll; or receiving b-cell inhibitory monoclonal antibody treatment (anti-cd20) and has received at least 3 cycles prior to enrollment; and/or receives a btk inhibitor, pi3k inhibitor, or bcl-2 inhibitor or is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age or is on active immunomodulator therapy (eg, tnfα inhibitor, or tofacitinib or methotrexate) for an autoimmune or inflammatory disease disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel disease, such as ulcerative colitis and crohn's disease) at a stable* dose (*stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to visit 1) or receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (visit 1), and is ≥2 to <18 years of age or has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to <18 years of age the participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), as described in appendix 1, which includes compliance with the requirements and restrictions listed in the icd and in this protocol. the investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian (as defined in appendix 1) before any study-specific activity is performed. all parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. the investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

inclusion criteria: male or female participants who are ≥2 years of age at the time of enrollment (visit 1). participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (visit 1). participants or participant's parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period. female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. participants who are immunocompromised by virtue of the following: having known nsclc and is ≥18 years of age with at least 1 of the following: who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or receiving checkpoint inhibitor treatment (pd-1/pd-l1 inhibitor, ctla-4 inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or receiving targeted drug therapy treatment (egfr, alk, ros1, braf, ret, met, ntrk inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or having known cll and is ≥18 years of age with at least 1 of the following: has asymptomatic disease (eg, rai stage <3, binet stage a or b) and is undergoing observation and does not receive any treatment for cll; or receiving b-cell inhibitory monoclonal antibody treatment (anti-cd20) and has received at least 3 cycles prior to enrollment; and/or receives a btk inhibitor, pi3k inhibitor, or bcl-2 inhibitor or is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age or is on active immunomodulator therapy (eg, tnfα inhibitor, or tofacitinib or methotrexate) for an autoimmune or inflammatory disease disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel disease, such as ulcerative colitis and crohn's disease) at a stable* dose (*stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to visit 1) or receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (visit 1), and is ≥2 to <18 years of age or has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to <18 years of age the participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), as described in appendix 1, which includes compliance with the requirements and restrictions listed in the icd and in this protocol. the investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian (as defined in appendix 1) before any study-specific activity is performed. all parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. the investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

Aug. 23, 2021, 7 p.m. usa

inclusion criteria: - 1. male or female participants who are ≥2 years of age at the time of enrollment (visit 1). 2. participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3. life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (visit 1). 4. participants or participant's parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period. 5. female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. 6. participants who are immunocompromised by virtue of the following: - having known nsclc and is ≥18 years of age with at least 1 of the following: - who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or - receiving checkpoint inhibitor treatment (pd-1/pd-l1 inhibitor, ctla-4 inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or - receiving targeted drug therapy treatment (egfr, alk, ros1, braf, ret, met, ntrk inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or - having known cll and is ≥18 years of age with at least 1 of the following: - has asymptomatic disease (eg, rai stage <3, binet stage a or b) and is undergoing observation and does not receive any treatment for cll; or - receiving b-cell inhibitory monoclonal antibody treatment (anti-cd20) and has received at least 3 cycles prior to enrollment; and/or - receives a btk inhibitor, pi3k inhibitor, or bcl-2 inhibitor or - is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age or - is on active immunomodulator therapy (eg, tnfα inhibitor, or tofacitinib or methotrexate) for an autoimmune or inflammatory disease disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel disease, such as ulcerative colitis and crohn's disease) at a stable* dose - stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to visit 1. or - receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (visit 1), and is ≥2 to <18 years of age or - has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to <18 years of age 7. the participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), as described in appendix 1, which includes compliance with the requirements and restrictions listed in the icd and in this protocol. the investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian (as defined in appendix 1) before any study-specific activity is performed. all parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. the investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

inclusion criteria: - 1. male or female participants who are ≥2 years of age at the time of enrollment (visit 1). 2. participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3. life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (visit 1). 4. participants or participant's parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period. 5. female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. 6. participants who are immunocompromised by virtue of the following: - having known nsclc and is ≥18 years of age with at least 1 of the following: - who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or - receiving checkpoint inhibitor treatment (pd-1/pd-l1 inhibitor, ctla-4 inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or - receiving targeted drug therapy treatment (egfr, alk, ros1, braf, ret, met, ntrk inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or - having known cll and is ≥18 years of age with at least 1 of the following: - has asymptomatic disease (eg, rai stage <3, binet stage a or b) and is undergoing observation and does not receive any treatment for cll; or - receiving b-cell inhibitory monoclonal antibody treatment (anti-cd20) and has received at least 3 cycles prior to enrollment; and/or - receives a btk inhibitor, pi3k inhibitor, or bcl-2 inhibitor or - is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age or - is on active immunomodulator therapy (eg, tnfα inhibitor, or tofacitinib or methotrexate) for an autoimmune or inflammatory disease disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel disease, such as ulcerative colitis and crohn's disease) at a stable* dose - stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to visit 1. or - receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (visit 1), and is ≥2 to <18 years of age or - has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to <18 years of age 7. the participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), as described in appendix 1, which includes compliance with the requirements and restrictions listed in the icd and in this protocol. the investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian (as defined in appendix 1) before any study-specific activity is performed. all parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. the investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

Aug. 14, 2021, 5 p.m. usa

inclusion criteria: - 1. male or female participants who are ≥2 years of age at the time of enrollment (visit 1). 2. participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3. life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (visit 1). 4. ability to be contacted by telephone throughout the study period. 5. female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. 6. participants who are immunocompromised by virtue of the following: • having known nsclc and is ≥18 years of age with at least 1 of the following: - who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or - receiving checkpoint inhibitor treatment (pd-1/pd-l1 inhibitor, ctla-4 inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or - receiving targeted drug therapy treatment (egfr, alk, ros1, braf, ret, met, ntrk inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or - having known cll and is ≥18 years of age with at least 1 of the following: - has asymptomatic disease (eg, rai stage <3, binet stage a or b) and is undergoing observation and does not receive any treatment for cll; or - receiving b-cell inhibitory monoclonal antibody treatment (anti-cd20) and has received at least 3 cycles prior to enrollment; and/or - receives a btk inhibitor, pi3k inhibitor, or bcl-2 inhibitor or - is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age or - is on active immunomodulator therapy (eg,tnfα inhibitor or tofacitinib) for an autoimmune or inflammatory disease at a stable* dose and is ≥2 to <18 years of age * stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to visit 1. or - receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (visit 1), and is ≥2 to <18 years of age or - has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to <18 years of age 7. the participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), as described in appendix 1, which includes compliance with the requirements and restrictions listed in the icd and in this protocol. the investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian (as defined in appendix 1) before any study-specific activity is performed. all parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. the investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

inclusion criteria: - 1. male or female participants who are ≥2 years of age at the time of enrollment (visit 1). 2. participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3. life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (visit 1). 4. ability to be contacted by telephone throughout the study period. 5. female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. 6. participants who are immunocompromised by virtue of the following: • having known nsclc and is ≥18 years of age with at least 1 of the following: - who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or - receiving checkpoint inhibitor treatment (pd-1/pd-l1 inhibitor, ctla-4 inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or - receiving targeted drug therapy treatment (egfr, alk, ros1, braf, ret, met, ntrk inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or - having known cll and is ≥18 years of age with at least 1 of the following: - has asymptomatic disease (eg, rai stage <3, binet stage a or b) and is undergoing observation and does not receive any treatment for cll; or - receiving b-cell inhibitory monoclonal antibody treatment (anti-cd20) and has received at least 3 cycles prior to enrollment; and/or - receives a btk inhibitor, pi3k inhibitor, or bcl-2 inhibitor or - is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age or - is on active immunomodulator therapy (eg,tnfα inhibitor or tofacitinib) for an autoimmune or inflammatory disease at a stable* dose and is ≥2 to <18 years of age * stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to visit 1. or - receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (visit 1), and is ≥2 to <18 years of age or - has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to <18 years of age 7. the participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), as described in appendix 1, which includes compliance with the requirements and restrictions listed in the icd and in this protocol. the investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian (as defined in appendix 1) before any study-specific activity is performed. all parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. the investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

May 25, 2021, 12:32 a.m. usa

inclusion criteria: - 1. male or female participants who are ≥2 years of age at the time of enrollment (visit 1). 2. participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3. life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (visit 1). 4. ability to be contacted by telephone throughout the study period. 5. female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. 6. participants who are immunocompromised by virtue of the following: - having known nsclc and is ≥18 years of age with at least 1 of the following: - who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or - receiving checkpoint inhibitor treatment (pd-1/pd-l1 inhibitor, ctla-4 inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or - receiving targeted drug therapy treatment (egfr, alk, ros1, braf, ret, met, ntrk inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or - having known cll and is ≥18 years of age with at least 1 of the following: - has asymptomatic disease (eg, rai stage <3, binet stage a or b) and is undergoing observation and does not receive any treatment for cll; or - receiving b-cell inhibitory monoclonal antibody treatment (anti-cd20) and has received at least 3 cycles prior to enrollment; and/or - receives a btk inhibitor, pi3k inhibitor, or bcl-2 inhibitor or - is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age or - is on active immunomodulator therapy (eg,tnfα inhibitor or tofacitinib) for an autoimmune or inflammatory disease at a stable* dose and is ≥2 to <18 years of age * stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to visit 1. or - receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (visit 1), and is ≥2 to <18 years of age or - has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to <18 years of age 7. the participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), as described in appendix 1, which includes compliance with the requirements and restrictions listed in the icd and in this protocol. the investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian (as defined in appendix 1) before any study-specific activity is performed. all parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. the investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

inclusion criteria: - 1. male or female participants who are ≥2 years of age at the time of enrollment (visit 1). 2. participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3. life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (visit 1). 4. ability to be contacted by telephone throughout the study period. 5. female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. 6. participants who are immunocompromised by virtue of the following: - having known nsclc and is ≥18 years of age with at least 1 of the following: - who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or - receiving checkpoint inhibitor treatment (pd-1/pd-l1 inhibitor, ctla-4 inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or - receiving targeted drug therapy treatment (egfr, alk, ros1, braf, ret, met, ntrk inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at visit 1); or - having known cll and is ≥18 years of age with at least 1 of the following: - has asymptomatic disease (eg, rai stage <3, binet stage a or b) and is undergoing observation and does not receive any treatment for cll; or - receiving b-cell inhibitory monoclonal antibody treatment (anti-cd20) and has received at least 3 cycles prior to enrollment; and/or - receives a btk inhibitor, pi3k inhibitor, or bcl-2 inhibitor or - is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age or - is on active immunomodulator therapy (eg,tnfα inhibitor or tofacitinib) for an autoimmune or inflammatory disease at a stable* dose and is ≥2 to <18 years of age * stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to visit 1. or - receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (visit 1), and is ≥2 to <18 years of age or - has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to <18 years of age 7. the participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), as described in appendix 1, which includes compliance with the requirements and restrictions listed in the icd and in this protocol. the investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian (as defined in appendix 1) before any study-specific activity is performed. all parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. the investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).