drugset / Trial / NCT04681833
Safety and Efficacy of BARS13 in the Elderly
RandomizedParallel-groupDouble-blindPrevention
Summary
Advaccine Clinical Research are developing a vaccine called BARS13 for the active immunisation of infants (aged 6 months to 5 years old) and the elderly (aged 60-80 years old) for the seasonal prevention of Respiratory Syncytial Virus (RSV) infection. A total of 125 volunteers aged 60 - 80 years (inclusive) will be enrolled in this study, and will be divided into 3 groups (or 'cohorts') of 40 people (cohort 1 and 2) and 45 people (cohort 3). The aim of the study is to evaluate the safety and tolerability of BARS13 in this age group.
Timeline
- Start
- 2021-05-24
- Primary completion
- 2024-01-26
- Completion
- 2024-04-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BARS13 | Vaccine | 10 ug | Intramuscular |