Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NoV Vaccine · 1 trial · 2 indications
GMBT50 of anti-norovirus GI. VLP antibody titers as measured by the histo-blood group antigen (HBGA) blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204) , at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107, NOR-210, NOR-204)
GMBT50 of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3 4 and 5 (NOR-107,NOR-210, NOR-204) .
| Arm | Type | Description |
|---|---|---|
| NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose | EXPERIMENTAL | Eligible participants who received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminium hydroxide, IM on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study. |
| NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose | EXPERIMENTAL | Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. |
| NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose | EXPERIMENTAL | Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. |
| NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose | EXPERIMENTAL | Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. |
| NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose | EXPERIMENTAL | Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. |
| NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose | EXPERIMENTAL | Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. |
| NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose | EXPERIMENTAL | Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. |
| NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose | EXPERIMENTAL | Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. |
| NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose | EXPERIMENTAL | Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. |
| NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose | EXPERIMENTAL | Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. |
| NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose | EXPERIMENTAL | Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. |
| NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose | EXPERIMENTAL | Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. |
| NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose | EXPERIMENTAL | Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. |
| NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose | EXPERIMENTAL | Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. |
| NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose | EXPERIMENTAL | Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study. |
| NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose | EXPERIMENTAL | Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. |
| NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 yrs) | EXPERIMENTAL | Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. |
| NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 yrs) | EXPERIMENTAL | Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. |
| NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose | EXPERIMENTAL | Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. |
| NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose | EXPERIMENTAL | Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. |
| Name | Type | Description |
|---|---|---|
| NoV Vaccine | BIOLOGICAL | NoV vaccine injection administered. |
Inclusion Criteria: 1\. Male and female participants who previously received at least 1 dose of NoV vaccine in trials NOR-107 (NCT02038907), NOR-210 (NCT02475278) and NOR-204 (NCT02661490), have baseline and post-vaccination data, and completed the primary vaccination trial protocol as initially de...
The NoV Vaccine is an investigational vaccine developed by Takeda Pharmaceutical Company Limited for the prevention of norovirus infection. It is a bivalent virus-like particle (VLP) vaccine targeting the norovirus GI.1 and GII.4 strains. It is currently in Phase 2 clinical development and has not been approved for use.
The NoV Vaccine is being developed to prevent norovirus infection in healthy adults. Norovirus is a common cause of acute gastroenteritis. The vaccine targets the GI.1 and GII.4 norovirus strains and is intended for immunization of adults 18 years of age and older. It remains investigational.
The NoV Vaccine is developed by Takeda Pharmaceutical Company Limited, which trades on the New York Stock Exchange under the ticker TAK. Takeda is the sponsor of the clinical program evaluating this bivalent norovirus GI.1/GII.4 virus-like particle vaccine candidate.
The NoV Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulatory authority. The completed Phase 2 trial evaluated long-term immunogenicity in adults.
The NoV Vaccine has been studied in one clinical trial, NCT03039790, titled Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults. This Phase 2 trial enrolled 528 healthy volunteers in the United States and Belgium and is now completed.
The NoV Vaccine is a bivalent virus-like particle (VLP) vaccine designed to target norovirus GI.1 and GII.4 strains. It presents virus-like particles to the immune system to stimulate an immune response against these norovirus genotypes. It is administered to healthy adult volunteers as an investigational preventive vaccine.