drugset / Trial / NCT05655182

A Study of BLB-201 RSV Vaccine in Infants and Children

NCT05655182 ↗

Phase 1/2 Recruiting 137 enrolled Blue Lake Biotechnology Inc.
RandomizedSequentialQuadruple-blindPrevention

Summary

This Phase 1/2a trial is a randomized, placebo-controlled trial to evaluate the safety, tolerability and immunogenicity of two ascending doses (10\^6 PFU and 10\^7 PFU) of intranasal BLB-201 (a recombinant parainfluenza virus type 5) administered in infants (8-24 months of age) and children (18-59 months of age) who may or may not have had prior respiratory syncytial virus (RSV) infection.

Timeline

Start
2023-03-09
Primary completion
2028-12-30
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject BLB-201 Vaccine 1e+06 unknown Intranasal
Subject BLB-201 Vaccine 1e+07 unknown Intranasal