(News Bulletin 247) – Pfizer and Valneva today announce that Pfizer, as sponsor of the study, has decided to discontinue a significant percentage of participants in the United States who had been enrolled in the clinical phase 3 VALOR. The study focuses on the efficacy, safety and immunogenicity of an experimental Lyme disease vaccine candidate, VLA15.
These study participants are being discontinued as a result of Good Clinical Practice (GCP) violations at certain clinical trial sites operated by a third-party clinical trial site operator. The dropout of these participants is not due to safety issues related to the experimental vaccine.
As soon as Pfizer became aware of the potential GCP violations, it conducted a thorough review of operations and data collection at third-party managed clinical trial sites and followed standard safeguards to determine the path to follow.
The clinical trial continues at other sites and Pfizer continues to recruit new participants. The two companies aim for Pfizer to submit a biologics license application to the US FDA and a marketing authorization (MA) application to the European Medicines Agency in 2025.
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