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

Phase III Study of ASP7374-Open-label Study of Subcutaneous Vaccination of Quadrivalent ASP7374 in Adult Subjects Aged 20 or Older

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

Study Overview

• Status: Completed
• Conditions: Influenza; Vaccine
• Intervention / Treatment: Biological: ASP7374

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASP7374 group	Biological: ASP7374; subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety assessed by adverse events	Up to Day 29

Secondary Outcome Measures

Outcome Measure	Time Frame
Local and systemic reactions associated with the vaccination	Up to Day 8

Collaborators and Investigators

• Sponsor: UMN Pharma Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: February 12, 2015
• First Submitted That Met QC Criteria: February 12, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Actual): September 29, 2017
• Last Update Submitted That Met QC Criteria: September 27, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Influenza; Vaccine; ASP7374
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 7374-CL-0107