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Active Not Recruiting
NCT06984094
Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
Conditions: RSV Infection, Human Metapneumovirus Infection, Parainfluenza Infection
Sex: All
Ages: 60 Years – 85 Years
Healthy volunteers: Yes
Phase: PHASE1, PHASE2
Enrollment: 612
Sponsor: Clover Biopharmaceuticals AUS Pty
Location: Fusion Clinical Research Adelaide Southern Australia
Summary
This phase 1/2 study will evaluate the safety, reactogenicity and immunogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Parts 1 and 2) or Placebo (Part 3).
Eligibility Criteria
Inclusion Criteria:
* Male and female participants 60 to 85 years of age at the screening visit.
* Individuals willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
* Individuals willing and able to give an informed consent, prior to screening.
* 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.
Please refer to Protocol for full list of Inclusion and Exclusion criteria.
Exclusion Criteria:
* Pregnancy or potential to become pregnant during the study.
* Acute disease or fever (≥38°C) at time of vaccination.
* History of Guillain-Barré Syndrome (GBS).
* Recurrent or un-controlled neurological disorders or seizures.
* Serious or unstable chronic illnesses. Please refer to Protocol for full list of Inclusion and Exclusion criteria.
Source: ClinicalTrials.gov (NCT06984094). StuddyBuddy aggregates publicly available trial information.
