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....
The Norovirus Bivalent Vaccine is an investigational vaccine developed by Takeda Pharmaceutical Company Limited for the prevention of norovirus infection. It is a bivalent vaccine candidate, meaning it is designed to cover more than one norovirus component. It is in Phase 1 clinical development and is not approved for use.
The Norovirus Bivalent Vaccine is being studied for the prevention of norovirus infection. Norovirus is an infectious disease target, and this vaccine candidate is intended to protect healthy adult volunteers from infection. It has been evaluated in a Phase 1 trial and is not currently an approved product.
The Norovirus Bivalent Vaccine is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program for this norovirus vaccine candidate.
The Norovirus Bivalent Vaccine is in Phase 1 clinical development. It is an investigational vaccine candidate and is not FDA approved. One Phase 1 trial has been completed, and no active trials are currently listed for this program.
The Norovirus Bivalent Vaccine has been studied in one clinical trial, NCT01609257, titled Norovirus Bivalent-Vaccine Efficacy Study. This Phase 1 trial enrolled 132 participants in the United States, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older. The trial is completed.