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A PHASE 3, MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, IMMUNOGENICITY, AND LOT CONSISTENCY OF A 6 VALENT OspA-BASED LYME DISEASE VACCINE IN HEALTHY PARTICIPANTS ≥5 YEARS OF AGE

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Trial Profile

A PHASE 3, MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, IMMUNOGENICITY, AND LOT CONSISTENCY OF A 6 VALENT OspA-BASED LYME DISEASE VACCINE IN HEALTHY PARTICIPANTS ≥5 YEARS OF AGE

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Mar 2025

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At a glance

  • Drugs VLA 15 (Primary)
  • Indications Lyme disease
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Acronyms VALOR
  • Sponsors Pfizer; Valneva

Most Recent Events

  • 03 Oct 2024 According to a Valneva media release, the company announced that it will host an investor day at the Lotte New York Palace Hotel in New York, NY on Thursday, October 10, 2024 at 10:00 AM ET (4:00 pm CET). The event will focus on this study.
  • 17 Jul 2024 According to a Valneva media release, Pfizer plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026, subject to positive data.
  • 17 Jul 2024 According to a Valneva media release, the participants of the Phase 3 trial (VALOR) have completed the primary vaccination series (three doses) of Lyme disease vaccine candidate VLA15. Participants will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025. Primary vaccination series to be followed by a booster approximately one year after completion.

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