(CercleFinance.com) – Valneva announces the success of the pivotal phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553, with its positive final analysis including six-month follow-up data confirming the initial results of last August.
The VLA1553-301 trial, which enrolled 4,115 adults in the United States, met all primary and secondary endpoints, including seroprotection in 98.9% of participants at one month and 96.3% at six months , and confirmed a good safety and tolerance profile.
Valneva now expects to begin the regulatory pre-submission process with the US FDA in the second quarter of 2022. Its chikungunya program received Breakthrough Therapy status from the FDA in July 2021.