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Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults

RecruitingPhase 1Ages 60 Years - 85 YearsAllClover Biopharmaceuticals USA, LLC
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In plain words

What the trial is, and whether it could suit you

CLO-SCB-1019-002 is the first study of SCB-1019T vaccine for revaccination in older adults who were previously vaccinated with AREXVY. The safety, tolerability and immunogenicity of SCB-1019T are assessed.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male and female participants 60-85 years of age at the screening visit and who received AREXVY before. 2. Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures. 3. Individuals willing and able to give an informed consent, prior to screening. 4. Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included (a stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment). Please refer to Protocol for full list of Inclusion and Exclusion criteria. Exclusion Criteria: 1. Acute disease or fever (โ‰ฅ38ยฐC) at time of vaccination. Participants with a minor illness (mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled within the allowed time-window. 2. Recurrent or un-controlled neurological disorders or seizures. 3. Serious or unstable chronic illnesses 4. Any history of dementia or any medical condition that moderately or severely impairs cognition 5. History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines. Please refer to Protocol for full list of Inclusion and Exclusion criteria.
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What it tests

  • Candidate vaccine, SCB-1019T
  • AREXVY
  • placebo
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Where

5 sites
AMR Phoenix
Phoenix, United States
AMR Fort Myers
Fort Myers, United States
AMR Lexington
Lexington, United States
AMR Kansas City
Kansas City, United States
Knoxville
Knoxville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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