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A Multicenter, Randomized, Controlled, Double Blinded Pivotal Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Virus Vaccine Candidate (VLA1553) in Adolescents Aged 12 Years to <18 Years

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Trial Profile

A Multicenter, Randomized, Controlled, Double Blinded Pivotal Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Virus Vaccine Candidate (VLA1553) in Adolescents Aged 12 Years to <18 Years

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Apr 2025

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At a glance

  • Drugs VLA 1553 (Primary)
  • Indications Chikungunya virus infections
  • Focus Pharmacodynamics; Registrational

Most Recent Events

  • 01 Apr 2025 According to a Valneva media release, company announced that the European Commission (EC) has granted marketing authorization in Europe for Valnevas single-dose vaccine, IXCHIQ, for the prevention of disease caused by the chikungunya virus in individuals 12 years of age and older.
  • 01 Apr 2025 According to a Valneva media release, company announced that it has submitted a label extension application to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) to potentially expand the use of its chikungunya vaccine, IXCHIQ, currently approved in adults1, to adolescents aged 12 to 17 years in the UK based on this trial
  • 28 Feb 2025 According to a Valneva media release, announced that the CHMP of the EMA has adopted a positive opinion recommending authorization of a label extension for IXCHIQ, Valneva single-dose vaccine for the prevention of disease caused by the chikungunya virus, to individuals 12 years of age and older. The European Commission (EC) will now review the CHMP recommendation, and a decision on the label extension application of IXCHIQ in the European Union (EU), Norway, Liechtenstein and Iceland is expected

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