Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Norovirus GI.1/GII.4 Bivalent VLP Vaccine · 1 trial · 1 indication
Solicited local AEs at the injection site that occurred within 7 days after each vaccination were collected using a diary and included pain, erythema swelling and induration.
Solicited local AEs at the injection site that occurred within 7 days after each vaccination were collected using a diary and included pain, erythema, swelling and induration.
Solicited systemic AEs that occurred within 7 days after each vaccination were collected using a diary and included headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea.
Solicited systemic AEs that occurred within 7 days after each vaccination were collected using a diary and included headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea.
The body temperature measurement was performed using the thermometer for 7 days after each vaccination. The highest body temperature observed each day was recorded on the diary card. An elevated temperature is ≥ 38 °C or 100.4°F (considered as fever).
The body temperature measurement was performed using the thermometer for 7 days after each vaccination. The highest body temperature observed each day was recorded on the diary card. An elevated temperature is ≥ 38 °C or 100.4°F (considered as fever).
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
| Arm | Type | Description |
|---|---|---|
| Arm 1: NoV Vaccine Formulation A _1-Dose | EXPERIMENTAL | Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29. |
| Arm 2: NoV Vaccine Formulation A _2-Dose | EXPERIMENTAL | Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29. |
| Arm 3: NoV Vaccine Formulation B_1-Dose | EXPERIMENTAL | Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29. |
| Arm 4: NoV Vaccine Formulation B_2-Dose | EXPERIMENTAL | Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29. |
| Arm 5: NoV Vaccine Formulation A_1-Dose | EXPERIMENTAL | Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29. |
| Name | Type | Description |
|---|---|---|
| Norovirus GI.1/GII.4 Bivalent VLP Vaccine | BIOLOGICAL | Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide, without MPL for IM injection |
| 0.9% sodium chloride (saline) | DRUG | norovirus bivalent placebo-matching vaccine |
Inclusion Criteria: 1. Is aged 18 to 49 years, or 60 years and older at the time of enrollment; 2. Participants who are in good health, or in stable health status with no exclusionary medical or neuropsychiatric conditions at the time of entry into the trial as determined by medical history, physic...
Norovirus GI.1/GII.4 Bivalent VLP Vaccine is an investigational vaccine being developed for the prevention of norovirus infection. It is designed to target norovirus, a leading cause of acute gastroenteritis. The vaccine is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Norovirus GI.1/GII.4 Bivalent VLP Vaccine targets norovirus, specifically the GI.1 and GII.4 genotypes. It is a bivalent virus-like particle vaccine, meaning it contains virus-like particles from two norovirus strains to elicit an immune response against both. The vaccine is being studied for its safety and immunogenicity.
Norovirus GI.1/GII.4 Bivalent VLP Vaccine is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is publicly traded on the New York Stock Exchange under the ticker symbol TAK. The vaccine is currently in Phase 2 clinical development.
Norovirus GI.1/GII.4 Bivalent VLP Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA or other regulatory agencies. A Phase 2 clinical trial has been completed to evaluate its safety and immunogenicity in an elderly population.
Norovirus GI.1/GII.4 Bivalent VLP Vaccine has one completed clinical trial, identified as NCT02661490. This Phase 2 study, titled 'Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in an Elderly Population,' enrolled 320 participants in the United States. The trial was randomized, double-blind, and controlled.
Norovirus GI.1/GII.4 Bivalent VLP Vaccine is a specific norovirus vaccine candidate. It is a bivalent virus-like particle vaccine designed to protect against two norovirus genotypes, GI.1 and GII.4. It is being developed by Takeda and is currently in Phase 2 clinical trials.