Last updated: September 8, 2023
Sponsor: AstraZeneca
Overall Status: Active - Recruiting
Phase
3
Condition
Vaccines
Treatment
N/AClinical Study ID
TX316745
Ages 12-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participant must be 12 years of age or older at the time of signing the informed consent.
- Weight ≥ 40 kg at screening.
Participants must satisfy at least 1 of the following risk factors at enrollment:
- Have solid tumor cancer and be on active immunosuppressive treatment
- Have hematologic malignancy
Transplant participants must satisfy at least one of the following:
- Have had a solid organ transplant within 2 years and / or
- Had a hematopoietic stem cell transplant within 2 years and / or
- Who have chronic graft-versus-host disease
- Participants who previously had a solid organ transplant or hematopoietic stem cell transplant more than 2 years prior to Visit 1 may also be eligible based on the inclusion criterion for immunosuppressive treatment
- Are actively taking immunosuppressive medicines (eg, are using corticosteroids [ie, ≥ 20 mg prednisone or equivalent per day when administered for ≥ 2 weeks], high dose alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive [eg, Bruton's tyrosine kinase inhibitors], tumor-necrosis blockers, or other immunosuppressive or immunomodulatory biologic agents (eg, for rheumatic diseases)
- Received chimeric antigen receptor T cell therapy
- Within 1 year of receiving B-cell depleting therapies (eg, rituximab, ocrelizumab, ofatumumab, alemtuzumab)
- Have a moderate or severe primary (eg, DiGeorge syndrome) or secondary (eg, hemodialysis) immunodeficiency
- Advanced or untreated HIV infection (people with HIV and CD4 cell counts < 200/mm3 within 6 months of Visit 1, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
Exclusion
Exclusion Criteria:
- Receipt of convalescent COVID-19 plasma treatment within 6 months prior to Visit 1.
- Previous receipt of a mAb against SARS-CoV-2 within 6 months prior to Visit 1.
- Receipt of a COVID-19 vaccine within 3 months prior to Visit 1.
- Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1.
- COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test [including at home testing]).
Study Design
Study Start date:
Estimated Completion Date:
Study Description
Connect with a study center
AMR Kansas City (formerly Center for Pharmaceutical Research)
Kansas City, Missouri 64114
United StatesActive - Recruiting
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