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

NCT02366962 | Completed Phase 3

• 1 other identifier: 7374-CL-0107
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

Influenza; Vaccine

Keywords

Influenza; Vaccine; ASP7374

Outcome Measures

Primary Outcomes (1)

• Safety assessed by adverse events

  Up to Day 29

Secondary Outcomes (1)

• Local and systemic reactions associated with the vaccination

  Up to Day 8

Study Arms (1)

ASP7374 group

EXPERIMENTAL

Biological: ASP7374

Interventions

ASP7374 BIOLOGICAL

subcutaneous

ASP7374 group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• \. Within 28 days prior to vaccination with the study vaccine
• Interferon formulation
• Drugs which affect the immune system (e.g., immunosuppressants)
• Systemic corticosteroids and inhaled corticosteroids
• G-CSF and M-CSF
• \. Within 84 days prior to vaccination with the study vaccine
• Human immunoglobulin products
• Blood products
• Blood transfusion
• \. Within 180 days prior to vaccination with the study vaccine

Sponsors & Collaborators

• UMN Pharma Inc.: lead

Study Sites (1)

Unknown Facility

Fukuoka, Japan

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 19, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

JP (1)