A Study to Evaluate Intramuscular ASP7374

Phase 3 Study of ASP7374 -Open-label Study of Intramuscular ASP7374 in Adults ≥61 Years of Age-

The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374 in adults ≥61 years of age.

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
  • Kanto, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy or 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.
• Written informed consent has been obtained.

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: Interferon formulation, Drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, Human immunoglobulin products, Blood products, Blood transfusion
• 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, except for febrile seizures in childhood

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• 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; intramuscular

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemagglutination inhibition (HI) antibody titer	evaluated for A/H1N1, A/H3N2, and B	Day 1 and Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neutralizing antibody titer	evaluated for A/H1N1, A/H3N2, and B	Day 1 and Day 29
Local and systemic reactions associated with the vaccination		Day 1 through Day 8

Collaborators and Investigators

• Sponsor: UMN Pharma Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 10, 2013
• First Submitted That Met QC Criteria: October 10, 2013
• First Posted (Estimate): October 14, 2013

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: ASP7374; Prevention of seasonal influenza
• 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-0105