Study of ASP7374, Cell-culture-derived Influenza Vaccine
NCT ID: NCT01961947
Last Updated: 2017-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
900 participants
INTERVENTIONAL
2013-10-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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ASP7374 group
ASP7374
subcutaneous
TIV group
approved egg-derived TIV
subcutaneous
Interventions
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ASP7374
subcutaneous
approved egg-derived TIV
subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject understands procedure of the protocol and is willing to comply with the protocol.
* Written informed consent has been obtained.
Exclusion Criteria
* 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.
* 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 (including chicken, poultry, foodstuffs derived from chicken, et al.) 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
20 Years
64 Years
ALL
Yes
Sponsors
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UMN Pharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: PRINCIPAL_INVESTIGATOR
Astellas Pharma Inc
Locations
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Kanto, , Japan
Kyushu, , Japan
Countries
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Other Identifiers
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7374-CL-0102
Identifier Type: -
Identifier Source: org_study_id