Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to confirm the safety until Day 29 after injection of a single dose of quadrivalent vaccine ASP7374 in adult subjects aged 20 or older
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP7374 group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP7374 | Biological | subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by adverse events | Up to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Local and systemic reactions associated with the vaccination | Up to Day 8 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Scheduled to receive another vaccine during the study.
Received influenza HA vaccine within 180 days prior to screening.
Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine.
Diagnosis of immune deficit in the past has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome.
Received one of the following medications or treatment prior to vaccination with the study vaccine:
1. Within 28 days prior to vaccination with the study vaccine
2. Within 84 days prior to vaccination with the study vaccine
3. Within 180 days prior to vaccination with the study vaccine
History of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
History of seizures (exclude a pyrexial attack in childhood)
History of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM)
Body temperature of ≥37.5°C on Day 1 (before vaccination)
Moderate to severe acute or febrile illness (≥37.5°C) within 7 days prior to vaccination
Concurrent hepatic disease (exclude fatty liver, hepatic cyst, biliary stone and gallbladder poly, which have laboratory findings only, no clinical symptoms, and not necessary to treat), or AST (GOT) and/or ALT (GPT) of >100 IU/L at screening on Day 1
Concurrent renal disease (exclude rental cyst and calculus kidney which have laboratory findings only, no clinical symptoms, and not necessary to treat), or creatinine of > 1.5 mg/dL at screening
Concurrent respiratory disease, hematologic disease, or developmental disorders
Concurrent or previous heart disease
Concurrent or previous cerebrovascular disorder
Concurrent malignancy or diagnosis or treatment of malignancy within 5 years before screening
Diagnosis of mental disorder including schizophrenia, bipolar disorder, or major depressive disorder or cognitive impairment, or received medications for cognitive impairment
Concurrent disease interfering with the evaluation of local and systemic reactions
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |