Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hepatitis A Vaccine · 1 trial · 2 indications
Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.
Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.
Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.
Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.
Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.
Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.
A serious adverse event (SAE) is any untoward medical occurrence or effect 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 |
|---|---|---|
| GI.1/GII.4 (15/15) - MPL (50) | EXPERIMENTAL | 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 aluminum hydroxide, IM on Day 28. |
| GI.1/GII.4 (15/50) - MPL (50) | EXPERIMENTAL | 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 MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| GI.1/GII.4 (50/50) - MPL (50) | EXPERIMENTAL | 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 MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| GI.1/GII.4 (15/15) - MPL (15) | EXPERIMENTAL | 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 MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| GI.1/GII.4 (15/50) - MPL (15) | EXPERIMENTAL | 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 MLP and 500 µg aluminum hydroxide, on Day 28. |
| GI.1/GII.4 (50/50) - MPL (15) | EXPERIMENTAL | 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 MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| GI.1/GII.4 (15/15) | EXPERIMENTAL | 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 aluminum hydroxide, IM, on Day 28. |
| GI.1/GII.4 (15/50) | EXPERIMENTAL | 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 aluminum hydroxide, IM, on Day 28. |
| GI.1/GII.4 (50/50) | EXPERIMENTAL | 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 aluminum hydroxide, IM, on Day 28. |
| GI.1/GII.4 (50/150) | EXPERIMENTAL | 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 aluminum hydroxide, IM, on Day 28. |
| GI.1/GII.4 (15/50) - Al(OH)3 (167) | EXPERIMENTAL | 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 aluminum hydroxide, IM, on Day 28. |
| GI.1/GII.4 (15/50) x2 | EXPERIMENTAL | Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
| GI.1/GII.4 (50/150) x2 | EXPERIMENTAL | Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
| GI.1/GII.4 (15/50) - Al(OH)3 (167) x2 | EXPERIMENTAL | Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
| Name | Type | Description |
|---|---|---|
| Hepatitis A Vaccine | BIOLOGICAL | Hepatitis A Vaccine IM injection |
| Norovirus Bivalent VLP Vaccine | BIOLOGICAL | Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection |
Inclusion Criteria: 1. Male and female participants between 18 and 64 years of age at the time of enrollment. 2. In good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator. 3. The parti...
Hepatitis A Vaccine is an investigational monoclonal antibody being studied for the prevention of hepatitis A in healthy volunteers. It is currently in Phase 2 clinical development, with one completed trial evaluating its safety and immunogenicity.
Hepatitis A Vaccine is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research to evaluate the vaccine's safety and immunogenicity in healthy volunteers.
Hepatitis A Vaccine is in Phase 2 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 2 trial has been completed, with 420 participants enrolled.
Hepatitis A Vaccine has been studied in one completed Phase 2 trial, NCT02038907, titled 'Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine.' The trial enrolled 420 healthy volunteers in Belgium and was double-blind and randomized.
Hepatitis A Vaccine is not the same as Norovirus GI.1/GII.4 Bivalent VLP Vaccine. The clinical trial NCT02038907 evaluated the Norovirus vaccine, and Hepatitis A Vaccine is a separate investigational product being developed by Takeda.