Clinical trial NCT02366962: A Study to Assess the Safety of ASP7374 in Adult Subjects Aged 20 or Older
Official title: Phase III Study of ASP7374-Open-label Study of Subcutaneous Vaccination of Quadrivalent ASP7374 in Adult Subjects Aged 20 or Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Vaccine
Keywords: Influenza
Vaccine
ASP7374
Lead sponsor: UMN Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: 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

    1. Interferon formulation
    2. Drugs which affect the immune system (e.g., immunosuppressants)
    3. Systemic corticosteroids and inhaled corticosteroids
    4. G-CSF and M-CSF
  * 2. Within 84 days prior to vaccination with the study vaccine

    1. Human immunoglobulin products
    2. Blood products
    3. Blood transfusion
  * 3. Within 180 days prior to vaccination with the study vaccine

    1. 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

Primary outcomes:
measure: Safety assessed by adverse events
timeFrame: Up to Day 29
Secondary outcomes:
measure: Local and systemic reactions associated with the vaccination
timeFrame: Up to Day 8
Other outcomes:
Locations:
city: Fukuoka
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: