Trials / Completed
CompletedNCT03721549
Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- WCCT Global · Industry
- Sex
- All
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Norwalk GI.1 Virus | Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu. |
Timeline
- Start date
- 2018-10-03
- Primary completion
- 2018-11-28
- Completion
- 2018-11-28
- First posted
- 2018-10-26
- Last updated
- 2020-01-22
- Results posted
- 2020-01-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03721549. Inclusion in this directory is not an endorsement.