Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Norovirus Bivalent Vaccine · 1 trial · 1 indication
Viral AGE due to Norovirus GII.4 strain during the inpatient stay that meets clinical illness definition 1,2 or 3 and positive for infection as measured by fecal virus excretion detected by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) OR a 4-fold rise in Immunoglobulin G Enzyme-Linked Immunosorbent Assay (IgG ELISA) anti-GII.4 norovirus P particle antibody titer from pre-challenge (Within 2 weeks of Challenge Day 0) to post-challenge (Challenge Day 30). The clinical illness definitions are 1: diarrhea (defined as ≥ 3 loose or liquid stools OR \>400-600 grams of loose or liquid stools produced in any 24-hour period), 2: vomiting (defined as ≥ 2 vomiting episodes in any 24-hour period) or 3. One Vomiting episode plus any loose or liquid stool in any 24-hour period OR one vomiting episode plus at least 2 of the following 5 events: nausea, fever ≥99.7°F orally, abdominal cramps or pains, abdominal gurgling or bloating, or myalgia in any 24-hour period.
Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.
Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.
Systemic signs or symptoms included: elevated daily oral temperature (fever), headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.
Systemic signs or symptoms included: elevated fever, headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.
A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
| Arm | Type | Description |
|---|---|---|
| Norovirus Bivalent VLP Vaccine | EXPERIMENTAL | Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28. |
| Placebo | PLACEBO_COMPARATOR | Saline Placebo (0.9% sodium chloride (NaCl) and preservative-free), intramuscular (IM), Days 0 and 28. |
| Name | Type | Description |
|---|---|---|
| Norovirus Bivalent Vaccine | BIOLOGICAL | 2 doses IM 28 days apart |
| Saline Comparator | BIOLOGICAL | 2 doses IM 28 days apart |
Inclusion Criteria: To be eligible to participate in this study, a subject must meet the following criteria: 1. Signed informed consent. 2. Age 18 to 50 years (e.g., not reached their 50th birthday). 3. Good general health as determined by a screening evaluation within 45 days of randomization. 4....
Norovirus Bivalent Vaccine is an investigational vaccine being developed for the prevention of norovirus infection. It is designed to protect against norovirus, a common cause of gastroenteritis. The vaccine is currently in clinical development and has not been approved for use.
Norovirus Bivalent 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 company is conducting clinical trials to evaluate the vaccine's safety and efficacy.
Norovirus Bivalent Vaccine is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine is still undergoing clinical evaluation to determine its safety and immune response.
Norovirus Bivalent Vaccine has one completed clinical trial registered under NCT01609257, titled "Norovirus Bivalent-Vaccine Efficacy Study." This Phase 1 trial enrolled 132 participants in the United States, including healthy volunteers aged 18 years and older. The study was randomized, double-blind, and placebo-controlled.
Norovirus Bivalent Vaccine is classified as a monoclonal antibody modality, though it is being developed as a vaccine for the prevention of norovirus infection. The vaccine is designed to elicit an immune response against norovirus, and it is currently in Phase 1 clinical trials.