No participant recruited; trial initiation postponed to an unspecified future time while Valneva assesses potential pathways to address regulatory requests. Evaluation is ongoing to ensure alignment with regulatory expectations and obligations.
Summary
VLA1553-322 is a multicenter, prospective, randomized, double-blind, phase 3 clinical trial evaluating VLA1553 in comparison to a comparator (Nimenrix®) for each stratum (age group). At least 3,000 male and female healthy children aged 1 to 11 years will be enrolled and randomized 3:1 to either VLA1553 (n=2,250) or comparator (Nimenrix®) (n=750).
Protocol Amendment History
3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-08-13; most recent amendment 2025-12-23.
Status change: Not Yet Recruiting → Withdrawn2025-12-23