VALN - Valneva completes lot-to-lot consistency trial for one-shot chikungunya vaccine
Valneva (NASDAQ:VALN) said it successfully completed a lot-to-lot phase 3 trial of its single-shot chikungunya vaccine VLA1553. The company said the final analysis included six-month follow-up data and confirmed the results reported in December 2021, where the trial met its main goal. "We are extremely pleased that the final lot-to lot data confirmed the previously reported topline results. We have now all necessary clinical data to support submission with the US Food and Drug Administration (FDA), which we plan to start later this year," said Valneva's Chief Medical Officer Juan Carlos Jaramillo. The VLA1553-302 study met its main goal, showing that three consecutively manufactured vaccine lots generated equivalent immune responses measured by neutralizing antibody titer on Day 29 after vaccination. The company said the the immunogenicity profile from study VLA1553-301 was also confirmed, with a 96% seroprotection rate at Day 180. The trial included 408 people aged 18 years to 45 years. The safety
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Valneva completes lot-to-lot consistency trial for one-shot chikungunya vaccine