A Study of BLB-201 RSV Vaccine in Infants and Children
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-5
SponsorBlue Lake Biotechnology Inc.
About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
None
Trial design
Treatments tested in this trial
- PIV5-vectored RSV Vaccine (BLB-201) Low Dose
- PIV5-vectored RSV Vaccine (BLB-201) High Dose
- Placebo
Treatment groups
137 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Locations
15California
Paradigm Clinical Research91942, La Mesa United States
Paradigm Clinical Research - Modesto95355, Modesto United States
Colorado
Paradigm Clinical Research Centers, LLC - Colorado, 1550 South Potomac Street, Suite 34080012, Aurora United States
Idaho
Velocity Clinical Research, Boise83642, Meridian United States
Sponsors and collaborators
Blue Lake Biotechnology Inc.
Lead sponsor
Source ClinicalTrials.gov