drugset / Trial / NCT04681833

Safety and Efficacy of BARS13 in the Elderly

NCT04681833 ↗

Phase 2 Completed 125 enrolled Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Subject BARS13 Vaccine 10 ug Intramuscular