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Norwalk VLP Vaccine · 2 trials · 3 indications
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. |
| Vaccine Arm 1 | EXPERIMENTAL | 50 µg Norwalk VLP Vaccine + Adjuvant/Excipients |
| Vaccine Arm 2 | EXPERIMENTAL | 100 µg Norwalk VLP Vaccine + Adjuvant/Excipients |
| Adjuvant/Excipients (MPL) | ACTIVE_COMPARATOR | 14 mg chitosan, 3 mg mannitol, 3 mg sucrose, and 50 mcg MPL |
| Empty device | SHAM_COMPARATOR | Empty device that contains no dry powder formulation. Actuation of the empty intranasal delivery device will deliver a puff of air per device. |
| 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 |
| Adjuvant/Excipients | DRUG | intranasal,14 mg chitosan, 3 mg mannitol, 3 mg sucrose and 50 mcg of MPL, 2 doses 21 days apart |
| placebo | DEVICE | intranasal, puff of air, 2 doses, 21 days apart |
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...
The Norwalk VLP Vaccine is an investigational vaccine being developed for the prevention of acute gastroenteritis caused by norovirus infection. It is intended for use in adults aged 18 years and older. The vaccine is currently in Phase 1 clinical development and is not yet approved for use.
The Norwalk VLP Vaccine is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is listed on the stock exchange under the ticker symbol TAK. The vaccine is currently in Phase 1 clinical trials for the prevention of norovirus-related acute gastroenteritis.
The Norwalk VLP Vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Two Phase 1 clinical trials have been completed, with a total enrollment of 98 participants. The vaccine is being studied for the prevention of norovirus infection and acute gastroenteritis.
The Norwalk VLP Vaccine has been studied in two completed Phase 1 clinical trials. The first trial, NCT00806962, enrolled 61 participants and focused on norovirus infection. The second trial, NCT00973284, enrolled 98 participants and studied acute gastroenteritis and Norwalk virus infection. Both trials were conducted in the United States.
The Norwalk VLP Vaccine is a vaccine designed to protect against norovirus, which is a common cause of acute gastroenteritis. It is specifically developed to target Norwalk virus, a type of norovirus. The vaccine is currently in Phase 1 clinical trials and is not yet approved for public use.