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Norovirus Bivalent VLP Vaccine · 1 trial · 1 indication
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the primary injection.
Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after the primary injection.
Fever is defined as greater than or equal to 38°C (100.4°F). Oral body temperature measurement was performed using the thermometer provided by the site for 7 days after each injection. The highest body temperature observed each day was 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.
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.
AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESI included protocol specified Cardiac Disorders, Gastrointestinal Disorders, Immune System Disorders, Infections and Infestations, Musculoskeletal and Connective Tissue Diseases, Neuroinflammatory Disorders, Renal and Urinary Disorders, Skin Disorders, Thyroid Disorders, Vascular Disorders and Other Disorders.
AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESI included protocol specified Cardiac Disorders, Gastrointestinal Disorders, Immune System Disorders, Infections and Infestations, Musculoskeletal and Connective Tissue Diseases, Neuroinflammatory Disorders, Renal and Urinary Disorders, Skin Disorders, Thyroid Disorders, Vascular Disorders and Other Disorders.
Withdrawal due to an AE occurred if the participant experienced an AE that required early termination because continued participation imposed an unacceptable risk to the participant's health or the participant was unwilling to continue because of the AE.
| Arm | Type | Description |
|---|---|---|
| GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) | EXPERIMENTAL | Intramuscular (IM) norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365. |
| GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) | EXPERIMENTAL | IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365. |
| Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) | PLACEBO_COMPARATOR | IM saline placebo on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP ) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365. |
| Name | Type | Description |
|---|---|---|
| Norovirus Bivalent VLP Vaccine | BIOLOGICAL | Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with or without MPL and/or aluminum hydroxide IM injection |
| Placebo (Saline) | DRUG | Placebo-matching norovirus bivalent VLP vaccine |
Inclusion Criteria: 1. Male and female participants aged 18 to 49 years of age at the time of enrollment. 2. Are in good health at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator. 3. Participants with a signed informe...
The Norovirus Bivalent VLP 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, meaning it presents two norovirus components to the immune system. It is not approved and remains in clinical development.
The Norovirus Bivalent VLP Vaccine is being developed for norovirus prevention in healthy adults. Norovirus is a leading cause of acute gastroenteritis. The vaccine is intended to reduce the risk of norovirus illness by stimulating an immune response before exposure.
Takeda Pharmaceutical Company Limited develops the Norovirus Bivalent VLP Vaccine. Takeda is a Japanese pharmaceutical company traded on the Tokyo Stock Exchange and the New York Stock Exchange under the ticker TAK. The company's vaccine business has pursued norovirus prevention as part of its infectious disease portfolio.
The Norovirus Bivalent VLP Vaccine is in Phase 2 development. Its single reported clinical trial, NCT02142504, was a Phase 2 study that has been completed. The vaccine is investigational and has not been approved by the FDA for norovirus prevention.
The Norovirus Bivalent VLP Vaccine has been studied in one completed Phase 2 trial, NCT02142504, titled Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults. The trial enrolled 454 healthy adult volunteers aged 18 years and older in the United States and was randomized, double-blind, and placebo-controlled.
Yes. The Phase 2 trial of the Norovirus Bivalent VLP Vaccine, NCT02142504, used a placebo-controlled design. It was also randomized and double-blind, with 454 healthy adult participants enrolled in the United States. The study assessed safety and immunogenicity in adults aged 18 years and older.