Back to resultsA Study to Evaluate Intramuscular ASP7374
Primary Purpose
Influenza, Vaccine
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
ASP7374
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring ASP7374, Prevention of seasonal influenza
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ASP7374 group
Arm Description
Outcomes
Primary Outcome Measures
hemagglutination inhibition (HI) antibody titer
evaluated for A/H1N1, A/H3N2, and B
Secondary Outcome Measures
neutralizing antibody titer
evaluated for A/H1N1, A/H3N2, and B
Local and systemic reactions associated with the vaccination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01961960
Brief Title
A Study to Evaluate Intramuscular ASP7374
Official Title
Phase 3 Study of ASP7374 -Open-label Study of Intramuscular ASP7374 in Adults ≥61 Years of Age-
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UMN Pharma Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374 in adults ≥61 years of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Vaccine
Keywords
ASP7374, Prevention of seasonal influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASP7374 group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
ASP7374
Intervention Description
intramuscular
Primary Outcome Measure Information:
Title
hemagglutination inhibition (HI) antibody titer
Description
evaluated for A/H1N1, A/H3N2, and B
Time Frame
Day 1 and Day 29
Secondary Outcome Measure Information:
Title
neutralizing antibody titer
Description
evaluated for A/H1N1, A/H3N2, and B
Time Frame
Day 1 and Day 29
Title
Local and systemic reactions associated with the vaccination
Time Frame
Day 1 through Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Principal Investigator
Facility Information:
City
Kanto
Country
Japan
12. IPD Sharing Statement
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A Study to Evaluate Intramuscular ASP7374
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