Status:
COMPLETED
First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults
Lead Sponsor:
Clover Biopharmaceuticals AUS Pty
Conditions:
Respiratory Syncytial Virus Vaccination
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults
Detailed Description
A Phase 1, placebo-controlled, randomized, observer-blind, First-in-human Study to describe the Safety, reactogenicity and immunogenicity of a bivalent recombinant RSV vaccines (SCB-1019 and SCB-1019T...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Acute disease or fever (≥38°C) at time of vaccination.
- History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.
- Any progressive unstable or uncontrolled clinical conditions.
- Any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome.
- Please refer to Protocol for full list of Inclusion and Exclusion criteria.
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06194318
Start Date
December 13 2023
End Date
May 7 2025
Last Update
June 6 2025
Active Locations (2)
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1
Fusion Clinical Research
Adelaide, Southern Australia, Australia, 5067
2
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009