A Study to Evaluate Intramuscular ASP7374
Phase 3 Study of ASP7374 -Open-label Study of Intramuscular ASP7374 in Adults ≥61 Years of Age-
1 other identifier
interventional
55
1 country
1
Brief Summary
The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374 in adults ≥61 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 10, 2013
CompletedFirst Posted
Study publicly available on registry
October 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedSeptember 29, 2017
September 1, 2017
1 month
October 10, 2013
September 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
hemagglutination inhibition (HI) antibody titer
evaluated for A/H1N1, A/H3N2, and B
Day 1 and Day 29
Secondary Outcomes (2)
neutralizing antibody titer
Day 1 and Day 29
Local and systemic reactions associated with the vaccination
Day 1 through Day 8
Study Arms (1)
ASP7374 group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
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: 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMN Pharma Inc.lead
Study Sites (1)
Unknown Facility
Kanto, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2013
First Posted
October 14, 2013
Study Start
October 1, 2013
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
September 29, 2017
Record last verified: 2017-09