Phase-3 Study of ASP7374, Cell-culture-derived Influenza Vaccine
NCT ID: NCT01767896
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
1020 participants
INTERVENTIONAL
2012-10-31
2013-03-31
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
cell-culture-derived vaccine group
ASP7374
subcutaneous (sc)
TIV group
approved egg-derived TIV group
approved egg-derived TIV
subcutaneous (sc)
Interventions
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ASP7374
subcutaneous (sc)
approved egg-derived TIV
subcutaneous (sc)
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
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: Interferon formulation, drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, human immunoglobulin products, blood products
* 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
* History of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM)
* Confirmed diagnosis of influenza within 84 days prior to screening test
* Body temperature of ≥37.5°C on Day 1 (before vaccination)
* Immunological tests reveal positive HBs antigen, HCV antibody, and HIV antigen and/or antibody
65 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: STUDY_DIRECTOR
Astellas Pharma Inc
Locations
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Kansai, , Japan
Kantou, , Japan
Kyushu, , Japan
Countries
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Other Identifiers
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7374-CL-0103
Identifier Type: -
Identifier Source: org_study_id