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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00973284 | Norwalk Vaccine Study | PHASE1 | COMPLETED | 98 | — | — | Aug 4, 2009 | Aug 18, 2010 | Aug 8, 2017 | 3 | United States |
Viral AGE was a composite endpoint for the analysis of clinical illness and was defined as meeting one or more definitions of Norwalk Virus Infection and one or more of the definitions of AGE. Norwalk Virus Infection: * PAN-Immunoglobulin (Ig) Enzyme Linked Immunosorbent Assay (ELISA) for anti-Norwalk Virus Antibody IgM, IgG and IgA, ≥4-fold rise in titer in serum on Challenge Day 30 compared to Pre-Challenge. * Reverse Transcription Polymerase Chain Reaction (RT-PCR), a single positive post-challenge stool sample. * Norwalk Virus Antigen, a single positive post-challenge stool sample. Acute Gastroenteritis: -\>200 grams of watery feces in 24-hour collection that immediately takes the shape of the container. * Vomiting and watery feces ≤200 grams on the same or consecutive days. * One vomiting episode plus one of the following symptoms: abdominal cramps or pains, nausea, bloating, loose feces, fever ≥99.7° Fahrenheit, or myalgia on the same or consecutive days.
| Arm | Type | Description |
|---|---|---|
| Norwalk VLP Vaccine 100 µg | EXPERIMENTAL | Norwalk Virus-like Particle (VLP) Vaccine 100 µg, dry powder, intranasally using a delivery device with a puff of air, 50 µg in each nostril, on Days 0 and 21 in the Vaccination Stage. Norwalk Virus, 48 Reverse Transcription Polymerase Chain Reaction (RT-PCR) units, solution, orally, on Day 42 in the Challenge Stage. |
| Placebo | PLACEBO_COMPARATOR | Norwalk VLP placebo-matching vaccine, dry powder, intranasally using a delivery device with a puff of air, 50 µg in each nostril, on Days 0 and 21 in the Vaccination Stage. Norwalk Virus, 48 RT-PCR units, solution, orally, on Day 42 in the Challenge Stage. |
| Name | Type | Description |
|---|---|---|
| Norwalk VLP vaccine | BIOLOGICAL | Norwalk VLP vaccine dry powder |
| mannitol and sucrose | BIOLOGICAL | Mannitol and sucrose as placebo-matching Norwalk VLP Vaccine dry powder |
| Norwalk virus | BIOLOGICAL | Norwalk virus solution |
Inclusion Criteria: 1. Signed informed consents. 2. Age 18 - 50 years, inclusive. 3. Good general health as determined by a screening evaluation within 45 days of randomization. 4. Expressed interest, availability, and understanding to fulfill the study requirements including measures to prevent No...