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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366962
• Other study ID #: 7374-CL-0107
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2015
• Last updated: September 27, 2017
• Start date: February 2015
• Est. completion date: April 2015

Study information

• Verified date: September 2017
• Source: UMN Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Vaccine

Intervention

Biological:
• ASP7374
subcutaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UMN Pharma Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by adverse events		Up to Day 29
Secondary	Local and systemic reactions associated with the vaccination		Up to Day 8