Valneva says IXCHIQ ‘well tolerated’ by children ages 1-11 years

Valneva (VALN) announced six-month antibody persistence and safety data for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ, in 304 children. Partially funded by the Coalition for Epidemic Preparedness Innovations, with support from the European Union, the trial is intended to support a pivotal Phase 3 study in children, which the company expects to initiate in the first quarter of 2026, with the objective of extending the product label to this age group. Trial VLA1553-221’s six-month results were in line with the initial data the company reported for this trial in January 20251. A full dose elicited a more robust immune response in children aged one to eleven years at Day 15 and Day 180 post vaccination compared to a half dose, the company said. Overall, the immunological response profile was in line with what was previously observed inadults and adolescents. The strong immune response was confirmed in CHIKV-naive children with a 96.5% seroresponse rate at Day 180. VLA1553 was well tolerated in children aged one to eleven years regardless of the dose or previous CHIKV infection. No safety concerns were identified. The comparability of the VLA1553 doses tested in terms of safety and tolerability, along with the more pronounced immune response of the full dose observed for all age groups tested in children up to Day 180 post-vaccination, support the selection of the full dose for use in this population, Valneva said.