Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01322503 | Susceptibility of Human Volunteers With Different Histo-Blood With Different Histo-Blood Group Antigens to Norovirus | PHASE1 | COMPLETED | 40 | — | — | Oct 1, 2010 | Mar 1, 2011 | Feb 10, 2012 | 1 | United States |
The number of subjects that become infected, as measured by the number of subjects found to be shedding norovirus in their stool, as well as the number of symptomatic infections (viral shedding in addition to other symptoms such as vomiting, diarrhea, abdominal cramps) will be the primary outcome measure. We will also assess the number of subjects who show at least a 4-fold rise in antibodies against Norovirus (comparing pre-challenge and post-challenge antibody levels).
| Arm | Type | Description |
|---|---|---|
| Norovirus Challenge | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Norovirus | BIOLOGICAL | Norovirus challenge pool administered to each subject |
Inclusion Criteria: * Healthy adults between the ages of 18 and 49 years * Willing and able to provide written informed consent * Able to comply with all study procedures * Have a body mass index of at least 19 * Have a serum IgG antibody titer of \< 1:1,600 to Norovirus * Female subjects of child ...