Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: male or female greater than or equal to (>=) 18 years of age. participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures. participants are willing and able to give an informed consent, prior to screening. participants should be in generally good health except for the following chronic immune-mediated diseases: ra who received chronic ([>=] 3 months) immunosuppressive therapy with immunomodulators (such as methotrexate and abatacept), tnf-alpha inhibitors (such as etanercept, adalimumab, certolizumab, golimumab or infliximab), janus kinase (jak) inhibitors (such as tofacitinib or baricitinib), or interleukin-6 (il-6) receptor inhibitors (such as tocilizumab). ibd: (crohn's disease, ulcerative colitis or indeterminate colitis) who received chronic ([>=] 3 months) immunosuppressive therapy with tnf-alpha inhibitors (such as infliximab or adalimumab), immunomodulators (such as 6- mercaptopurine, azathioprine, or methotrexate), corticosteroids (such as prednisone, prednisolone, or methylprednisolone), or tacrolimus. rrms who received chronic ([>=] 6 months) stable disease modifying therapy (dmt) with platform therapeutics (beta-interferons, glatirameracetate, teriflunomide, dimethylfumarate), sphingosine-1-phosphate receptor (s1pr) modulators (fingolimod, ozanimod, siponimod) or monoclonals (natalizumab). participants should be in remission (ra, ibd), or have low disease activity (ra) or stable disease (rrms) without modification of immunosuppressive therapy (i.e. no dose change, no medication change, no rescue therapy) for at least 3 months (6 months for rrms) prior to enrollment and not anticipated to undergo a change in immunosuppressive therapy for 1 month after dose 2. female participant are eligible to participate in the study if not pregnant and breastfeeding. male participants must agree to employ acceptable contraception from the day of first dose of the study vaccine and during the entire study period and also refrain from donating sperm during this period.

inclusion criteria: male or female greater than or equal to (>=) 18 years of age. participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures. participants are willing and able to give an informed consent, prior to screening. participants should be in generally good health except for the following chronic immune-mediated diseases: ra who received chronic ([>=] 3 months) immunosuppressive therapy with immunomodulators (such as methotrexate and abatacept), tnf-alpha inhibitors (such as etanercept, adalimumab, certolizumab, golimumab or infliximab), janus kinase (jak) inhibitors (such as tofacitinib or baricitinib), or interleukin-6 (il-6) receptor inhibitors (such as tocilizumab). ibd: (crohn's disease, ulcerative colitis or indeterminate colitis) who received chronic ([>=] 3 months) immunosuppressive therapy with tnf-alpha inhibitors (such as infliximab or adalimumab), immunomodulators (such as 6- mercaptopurine, azathioprine, or methotrexate), corticosteroids (such as prednisone, prednisolone, or methylprednisolone), or tacrolimus. rrms who received chronic ([>=] 6 months) stable disease modifying therapy (dmt) with platform therapeutics (beta-interferons, glatirameracetate, teriflunomide, dimethylfumarate), sphingosine-1-phosphate receptor (s1pr) modulators (fingolimod, ozanimod, siponimod) or monoclonals (natalizumab). participants should be in remission (ra, ibd), or have low disease activity (ra) or stable disease (rrms) without modification of immunosuppressive therapy (i.e. no dose change, no medication change, no rescue therapy) for at least 3 months (6 months for rrms) prior to enrollment and not anticipated to undergo a change in immunosuppressive therapy for 1 month after dose 2. female participant are eligible to participate in the study if not pregnant and breastfeeding. male participants must agree to employ acceptable contraception from the day of first dose of the study vaccine and during the entire study period and also refrain from donating sperm during this period.

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

inclusion criteria: 1. male or female greater than or equal to (>=) 18 years of age. 2. participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures. 3. participants are willing and able to give an informed consent, prior to screening. 4. participants should be in generally good health except for the following chronic immune-mediated diseases: - ra who received chronic ([>=] 3 months) immunosuppressive therapy with immunomodulators (such as methotrexate and abatacept), tnf-alpha inhibitors (such as etanercept, adalimumab, certolizumab, golimumab or infliximab), janus kinase (jak) inhibitors (such as tofacitinib or baricitinib), or interleukin-6 (il-6) receptor inhibitors (such as tocilizumab). - ibd: (crohn's disease, ulcerative colitis or indeterminate colitis) who received chronic ([>=] 3 months) immunosuppressive therapy with tnf-alpha inhibitors (such as infliximab or adalimumab), immunomodulators (such as 6- mercaptopurine, azathioprine, or methotrexate), corticosteroids (such as prednisone, prednisolone, or methylprednisolone), or tacrolimus. - rrms who received chronic ([>=] 6 months) stable disease modifying therapy (dmt) with platform therapeutics (beta-interferons, glatirameracetate, teriflunomide, dimethylfumarate), sphingosine-1-phosphate receptor (s1pr) modulators (fingolimod, ozanimod, siponimod) or monoclonals (natalizumab). 5. participants should be in remission (ra, ibd), or have low disease activity (ra) or stable disease (rrms) without modification of immunosuppressive therapy (i.e. no dose change, no medication change, no rescue therapy) for at least 3 months (6 months for rrms) prior to enrollment and not anticipated to undergo a change in immunosuppressive therapy for 1 month after dose 2. 6. female participant are eligible to participate in the study if not pregnant and breastfeeding. 7. male participants must agree to employ acceptable contraception from the day of first dose of the study vaccine and during the entire study period and also refrain from donating sperm during this period.

inclusion criteria: 1. male or female greater than or equal to (>=) 18 years of age. 2. participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures. 3. participants are willing and able to give an informed consent, prior to screening. 4. participants should be in generally good health except for the following chronic immune-mediated diseases: - ra who received chronic ([>=] 3 months) immunosuppressive therapy with immunomodulators (such as methotrexate and abatacept), tnf-alpha inhibitors (such as etanercept, adalimumab, certolizumab, golimumab or infliximab), janus kinase (jak) inhibitors (such as tofacitinib or baricitinib), or interleukin-6 (il-6) receptor inhibitors (such as tocilizumab). - ibd: (crohn's disease, ulcerative colitis or indeterminate colitis) who received chronic ([>=] 3 months) immunosuppressive therapy with tnf-alpha inhibitors (such as infliximab or adalimumab), immunomodulators (such as 6- mercaptopurine, azathioprine, or methotrexate), corticosteroids (such as prednisone, prednisolone, or methylprednisolone), or tacrolimus. - rrms who received chronic ([>=] 6 months) stable disease modifying therapy (dmt) with platform therapeutics (beta-interferons, glatirameracetate, teriflunomide, dimethylfumarate), sphingosine-1-phosphate receptor (s1pr) modulators (fingolimod, ozanimod, siponimod) or monoclonals (natalizumab). 5. participants should be in remission (ra, ibd), or have low disease activity (ra) or stable disease (rrms) without modification of immunosuppressive therapy (i.e. no dose change, no medication change, no rescue therapy) for at least 3 months (6 months for rrms) prior to enrollment and not anticipated to undergo a change in immunosuppressive therapy for 1 month after dose 2. 6. female participant are eligible to participate in the study if not pregnant and breastfeeding. 7. male participants must agree to employ acceptable contraception from the day of first dose of the study vaccine and during the entire study period and also refrain from donating sperm during this period.