A Study to Assess the Safety of ASP7374 in Adult Subjects Aged 20 or Older

UMN Pharma

Status and phase: Completed; Phase 3

Conditions: Influenza; Vaccine

Treatments: Biological: ASP7374

Study type: Interventional

Funder types: Industry

Identifiers

NCT02366962

7374-CL-0107

Details and patient eligibility

About

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

Enrollment: 55 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Medically stable, as judged on the basis of history and concurrent diseases
• Subject understands procedure of the protocol and is willing to comply with the protocol.

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. Interferon formulation

    3. Drugs which affect the immune system (e.g., immunosuppressants)

    4. Systemic corticosteroids and inhaled corticosteroids

    5. G-CSF and M-CSF

  • 2. Within 84 days prior to vaccination with the study vaccine

    3. Human immunoglobulin products

    4. Blood products

    5. Blood transfusion

  • 3. Within 180 days prior to vaccination with the study vaccine

    4. High-dose human immunoglobulin products (≥200 mg/kg)

• 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

ASP7374 group

Experimental group

Treatment:

Biological: ASP7374