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Pfizer, Valneva Initiate Phase 3 Study Of Lyme Disease Vaccine Candidate VLA15

Pfizer Inc. (PFE) and Valneva SE (VALN) said that they have initiated a phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (NCT05477524), to investigate the efficacy, safety and immunogenicity of their investigational Lyme disease vaccine candidate, VLA15.

The phase 3 VALOR study is planned to enroll about 6,000 participants 5 years of age and older. The study is being conducted at up to 50 sites located in areas where Lyme disease is highly endemic, including Finland, Germany, the Netherlands, Poland, Sweden and the United States. Participants will receive three doses of VLA15 180 mircogram or saline placebo as a primary vaccination series followed by one booster dose of VLA15 or saline placebo (1:1 ratio).

According to the companies, data from the Phase 2 studies continue to demonstrate strong immunogenicity in adults as well as in children, with acceptable safety and tolerability profiles in both study populations.

Pending successful completion of the Phase 3 study, Pfizer could potentially submit a Biologics License Application to the U.S. Food and Drug Administration and Marketing Authorisation Application to the European Medicines Agency in 2025.

As per the terms of the collaboration agreement between Pfizer and Valneva, Pfizer will make a $25 million milestone payment to Valneva upon initiation of the Phase 3 study.

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