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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 is a Phase 2 study that has completed, run by Vaxart. The registered enrollment target is 135 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05626803
The ClinicalTrials.gov registry entry for NCT05626803 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vaxart, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05626803 reports 0 study locations.
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.
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