Bavarian Nordic has commenced a Phase III trial of its chikungunya vaccine, CHIKV VLP, targeting the paediatric population aged two to 11 years old.
This marks the first study of the single-dose, virus-like particle (VLP) for children.
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Under the brand name Vimkunya, the vaccine is currently available for individuals aged 12 years and above in the EU, the US, and the UK.
Sponsored by the company, the double-blind, placebo-controlled, global, randomised trial will assess the vaccine’s immunogenicity and safety in 720 subjects over a period of two years.
Primary outcomes from the trial are expected in the first half of 2028.
As a non-infectious vaccine, Vimkunya is available in a prefilled syringe and is suitable for a wide range of recipients, offering an advantage in disease prevention efforts.
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By GlobalDataThe vaccine is formulated to trigger a strong immune response, with the body beginning to build protective immunity potentially within one week following the administration of the dose.
Bavarian Nordic CEO and president Paul Chaplin said: “Upon the successful approvals earlier this year of our chikungunya vaccine for persons aged 12 and older, we are pleased to initiate this Phase III study in children for whom there are currently no vaccines available to prevent against chikungunya.
“This study represents a significant part of our commitment to the further development of the vaccine to help ensure access for people of all ages.”
The vaccine received approval from the US Food and Drug Administration (FDA) and the European Commission in February, followed by the UK in May 2025.
These approvals were based on outcomes from two Phase III trials involving over 3,500 healthy participants aged 12 years and above.
The trials showed that 97.8% of the vaccinated individuals aged 12 to 64 developed neutralising antibodies induced by the vaccine within 21 days, with a seroresponse rate of 46.6% at day eight and 96.8% at day 15.
The vaccine was found to be well tolerated, with most adverse events being mild or moderate.
Last year, Bavarian Nordic’s mpox vaccine induced an antibody response in adolescents, equivalent to that of adults, in a clinical trial by the US National Institutes of Health (NIH).
