Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 developed by Takeda Pharmaceutical Company Limited for the prevention of Norovirus infection and acute gastroenteritis. It is a virus-like particle (VLP) vaccine and is currently in Phase 1 clinical development. It has been studied in healthy adult volunteers.
The Norwalk VLP vaccine is being developed for the prevention of Norovirus infection and acute gastroenteritis. Norovirus is a leading cause of acute gastroenteritis worldwide. The vaccine is intended for use in healthy adults, as studied in Phase 1 trials.
The Norwalk VLP vaccine is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is a global pharmaceutical company based in Japan. The vaccine is part of Takeda's vaccine development portfolio.
The Norwalk VLP vaccine is in Phase 1 clinical development. It has completed Phase 1 trials but has not yet advanced to later-stage trials. It is an investigational vaccine and is not approved for any indication.
The Norwalk VLP vaccine has been studied in two completed Phase 1 trials: NCT00973284, titled Norwalk Vaccine Study, which enrolled 98 participants, and NCT00806962, titled Phase 1 Norwalk Vaccine Study, which enrolled 61 participants. Both trials were conducted in the United States in healthy adult volunteers.
Yes, the Norwalk VLP vaccine trials were randomized, double-blind, and placebo-controlled. The trials enrolled healthy adult volunteers aged 18 years and older. Both Phase 1 trials have been completed.