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

Phase 3

Completed

• Conditions: Vaccine; Influenza
• Interventions: Biological: ASP7374

• Registration Number: NCT02366962
• Lead Sponsor: UMN Pharma Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-19
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASP7374 group	ASP7374	-

Primary Outcome Measures

Name	Time	Method
Safety assessed by adverse events	Up to Day 29

Secondary Outcome Measures

Name	Time	Method
Local and systemic reactions associated with the vaccination	Up to Day 8