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14.03.2021
Valneva: Valneva, a specialty vaccine company focused on prevention of diseases with major unmet needs, and Pfizer today announced initiation of study VLA15-221. The VLA15-221 study builds on previous positive Phase 2 studies, incorporates new dose regimens and is anticipated to be the final Phase 2 study readout before a decision to progress into pivotal Phase 3 studies. As announced in December 2020, VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study. It will be the first VLA15 study to include a pediatric population (aged 5-17 years). Overall, the study will enroll approximately 600 healthy participants (aged 5-65 years) who will receive VLA15 or placebo. It will compare the three-dose vaccination schedule (Month 0-2-6) with a two-dose schedule (Month 0-6). Juan Carlos Jaramillo, Chief Medical Officer of Valneva commented, “This trial initiation marks an important step in the development of VLA15 toward a potential licensure. Including a pe