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21st Austria weekly - Valneva (05/06/2024)

09.06.2024

Valneva: Valneva, a French/Austrian specialty vaccine company, today announced that the results of two Phase 2 clinical trials of Lyme disease vaccine candidate, VLA15, were published in the peer-reviewed medical journal, The Lancet Infectious Diseases. These trials, as well as a third Phase 2 trial in pediatric participants, supported the design of the current pivotal Phase 3 trial, ‘Vaccine Against Lyme for Outdoor Recreationists’ (VALOR). The Phase 3 clinical trial, VALOR, is currently ongoing to investigate the efficacy, safety and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the United States, Canada and Europe. Enrollment of 9,437 participants for the trial was completed in December 2023. Subject to positive data, Pfizer aims to submit a Biologic License Application to the Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency in 2026.

 

(From the 21st Austria weekly https://www.boerse-social.com/21staustria (05/06/2024)


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21st Austria weekly - Valneva (05/06/2024)


09.06.2024, 1041 Zeichen



Valneva: Valneva, a French/Austrian specialty vaccine company, today announced that the results of two Phase 2 clinical trials of Lyme disease vaccine candidate, VLA15, were published in the peer-reviewed medical journal, The Lancet Infectious Diseases. These trials, as well as a third Phase 2 trial in pediatric participants, supported the design of the current pivotal Phase 3 trial, ‘Vaccine Against Lyme for Outdoor Recreationists’ (VALOR). The Phase 3 clinical trial, VALOR, is currently ongoing to investigate the efficacy, safety and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the United States, Canada and Europe. Enrollment of 9,437 participants for the trial was completed in December 2023. Subject to positive data, Pfizer aims to submit a Biologic License Application to the Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency in 2026.

 

(From the 21st Austria weekly https://www.boerse-social.com/21staustria (05/06/2024)



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