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Recruiting Phase 1 NCT06984094

First-in-human Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults

Phase 1 – testing safety in a small group of people
Conditions: Respiratory Syncytial Virus Vaccination Human Metapneumovirus Vaccination Parainfluenza Vaccination

Sponsor: Clover Biopharmaceuticals AUS Pty

trial.available_in: БГ
Overview
This phase 1 study will evaluate the safety, reactogenicity, and immunogenicity of 3 different dose levels of SCB-1022 and SCB-1033 in healthy adults aged 60-85 years.
Description
The study will descriptively evaluate three dose levels of SCB-1022 and SCB-1033. The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 study. The study will be overseen by a safety monitoring committee.
Who can participate
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.
Locations 1
Australia (1)
Fusion Clinical Research
Adelaide , Southern Australia
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
65 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
18.06.2025
Completion date
30.06.2026
Registry ID
NCT06984094
Source
anzctr
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