A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-ranging Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccine Administered Orally to Healthy Volunteers Aged Greater Than or Equal to 18 Years and Less Than or Equal to 80 Years Old
Latest Information Update: 18 Apr 2025
At a glance
- Drugs Bivalent Norovirus vaccine-Vaxart (Primary)
- Indications Norovirus infections
- Focus Adverse reactions; Pharmacodynamics
- Sponsors Vaxart
Most Recent Events
- 15 Apr 2025 Status changed from active, no longer recruiting to completed.
- 15 Oct 2024 According to Vaxart media release, data from this trial will be presented at IDWeek 2024.
- 17 Jun 2024 According to a Vaxart media release, the company is on track to receive feedback from FDA in mid-2024 on potential correlates of protection for norovirus, which will inform potential next steps, such as conducting a Phase 2b study and potentially a GII.4 challenge study.