drugset / Trial / NCT05655182
A Study of BLB-201 RSV Vaccine in Infants and Children
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BLB-201 | Vaccine | 1e+06 unknown | Intranasal |
| Subject | BLB-201 | Vaccine | 1e+07 unknown | Intranasal |