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.
Protocol Amendment History
9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2024-12-02; most recent amendment 2026-05-12.
Status change: Recruiting → Active, Not Recruiting2026-01-22