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NCT05626803 · ClinicalTrials.gov registry record · Phase 2
A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers
A Phase 2 study, sponsored by Vaxart.
- Completed
- Registry status
- Phase 2
- Development phase
- 135
- Enrollment target
NCT05626803: Completed Phase 2 study, sponsored by Vaxart.
NCT05626803 is a Phase 2 study that has completed, run by Vaxart. The registered enrollment target is 135 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05626803, a Phase 2 study, has completed, sponsored by Vaxart.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 135 participants
- Enrollment target
Study Summary
This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.
Primary Outcome
Solicited adverse events (AEs) are predefined signs and symptoms of reactogenicity for which the participants were specifically questioned, and which were noted by the participant in their Solicited Symptom Diary for 7 days after drug administration, including: * fever (any temperature 100.4°F or higher) * headache * myalgia (muscle pain) * abdominal pain * anorexia (defined as not eating) * nausea * vomiting * diarrhoea * malaise/fatigue. The severity of each solicited symptoms of reactogenic
Interventions
- DRUG Placebo
- DRUG Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose
- DRUG Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose
- DRUG Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2023-01-26 |
| Est. Completion | 2023-10-16 |
| Phase | Phase 2 |
What the finished NCT05626803 record still lists
NCT05626803 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05626803 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05626803 about?
NCT05626803 is a clinical study titled "A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers". This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the preven...
What is the current status of trial NCT05626803?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2023-01-26. Estimated completion is 2023-10-16.
What interventions are being tested in trial NCT05626803?
The interventions under investigation include: Placebo (DRUG), Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose (DRUG), Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose (DRUG), Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/dose (DRUG).
Who is sponsoring clinical trial NCT05626803?
This trial is sponsored by Vaxart, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05626803's enrollment target sits among peer trials
135 532nd of 2000 higher than 1,464 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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