clinical trial · NCT05844423
Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants
Pneumococcal Vaccines0.5 ml dose of 1.1 mcg VAX-240.5 ml dose of PCV200.5 ml dose of 2.2 mcg VAX-240.5 ml dose of 2.2/4.4 mcg VAX-24
brief summary
The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 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 the remainder of the sample size.
started
Mar 29, 2023
primary completion
Aug 25, 2025
completion
Aug 25, 2025
last updated
Sep 11, 2025
official title
Randomized, Observer-Blind, Active-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of 24-Valent PCV (VAX-24) in Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age With Pediatric Vaccines
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol