NCT03721549|CompletedPhase 1ResultsFDA Drug
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Sponsor study identifier
interventional
16
1 country
1
Study Start
October 3, 2018
Actual (reported)Primary Completion
November 28, 2018
Actual (reported)Study Completion
November 28, 2018
Actual (reported)There is a need for safe, highly infectious Norovirus inocula for use in Norovirus vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune response among vaccinated and unvaccinated subjects. The purpose of this study is to generate the infection and illness rate and immune response data necessary for the conduct of future investigation of Norovirus vaccine studies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 28, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 3, 2018
Actual (reported)October 24, 2018
Actual (reported)October 26, 2018
Actual (reported)November 28, 2018
Actual (reported)November 28, 2018
Actual (reported)January 22, 2020
Actual (reported)Frequency of Norovirus Gastroenteritis (NVG)
Occurrence of NVG within 7 days post-challenge
7 days post-challenge
Frequency of Serious Adverse Events (SAEs)
42 ± 3 days post-challenge
Moderate dose of Norwalk GI.1 Virus, 3.6x10\^5 genome copies
Higher dose of Norwalk GI.1 Virus, 1x10\^6 genome copies
Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
WCCT Global
Costa Mesa, California, 92626, United States
16 participants (actual enrollment reported by the registry).
First Submitted
October 24, 2018
First Posted
October 26, 2018
Study Start
October 3, 2018
Actual (reported)A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers
Contact the study team to confirm eligibility.
Primary Completion
November 28, 2018
Actual (reported)Study Completion
November 28, 2018
Actual (reported)Last Updated
January 22, 2020
Results First Posted
January 22, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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