clinical trial · NCT06720038
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants
Pneumococcal Vaccines0.5 mL of the low dose VAX-310.5 mL of the mid dose VAX-310.5 mL of the high dose VAX-310.5 mL dose of PCV200.5 mL of the High-PFS dose VAX-31
brief summary
The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll approximately 352 subjects. Stage 3 of the study will enroll approximately 500 subjects.
started
Nov 25, 2024
primary completion
Dec 1, 2027
completion
Dec 1, 2027
last updated
Jan 26, 2026
official title
A Phase 2, Randomized, Double-Blind, Active-Controlled, Dose-Finding Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age Concomitantly With Routine Pediatric Vaccines
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol