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Safety and Efficacy of BARS13 in the Elderly

NCT04681833 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-09-20

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

DRUG

Recombinant Respiratory Syncytial Virus Vaccine (BARS13) /placebo

Low Repeat Dose

DRUG

Recombinant Respiratory Syncytial Virus Vaccine (BARS13)

High Repeat Dose/High Repeat Multiple Dose

DRUG

Placebo

Liquid diluent/Lyophilised Powder

Sponsors & Collaborators

  • Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Natasha Martin, MBBS · CMAX Clinical Research Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-24
Primary Completion
2024-01-26
Completion
2024-04-02

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04681833 on ClinicalTrials.gov