Pfizer: phase 3 study with Valneva in Lyme disease
(CercleFinance.com) - Pfizer and Valneva have announced the start of a Phase 3 clinical study entitled VALOR (NCT05477524), to evaluate the efficacy, safety and immunogenicity of their investigational Lyme disease vaccine candidate, VLA15.
The study, which is randomised and placebo-controlled, is expected to enrol approximately 6,000 participants aged five years and above at up to 50 sites in disease-endemic regions, including Northern and Central Europe and the United States.
If successfully completed, Pfizer could submit marketing authorisation applications to the US FDA and the European Medicines Agency in 2025.
Under the terms of the agreement between Pfizer and Valneva, the US pharmaceutical giant will pay the French vaccine company a 25 million dollar milestone payment when the study begins.
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