Trial Profile
A Phase 3 Safety, Immunogenicity, and Lot-Consistency Trial of the VLP-Based Chikungunya Vaccine PXVX0317 in Healthy Adults and Adolescents
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 11 Mar 2024
Price :
$35
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At a glance
- Drugs VRC-CHKVLP059-00-VP (Primary) ; Adjuvants
- Indications Chikungunya virus infections
- Focus Adverse reactions; Pharmacodynamics; Registrational
- Acronyms CHIKV VLP
- Sponsors Bavarian Nordic; Emergent BioSolutions
- 06 Mar 2024 According to a Bavarian Nordic media release, in Feb 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment for the upcoming Marketing Authorisation Application (MAA) for CHIKV VLP.
- 23 Feb 2024 According to a Bavarian Nordic media release, company is on track and plans to submit its MAA for CHIKV VLP to the EMA during H1 2024. Company also plans to submit our biologics license application (BLA) for vaccine candidate to the U.S. Food and Drug Administration later this year.
- 06 Aug 2023 According to a Bavarian Nordic media release, the study met all the co-primary endpoints.