A Study to Evaluate the Immune Response to the ASP7373 and Its Safety in Healthy Adult Volunteers
NCT ID: NCT01450579
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
PHASE2
180 participants
INTERVENTIONAL
2011-07-31
2011-12-31
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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Placebo
Saline
Placebo
Intramuscular administration
Dose -1
ASP7373
ASP7373
Intermuscular administration
Dose -2
ASP7373
ASP7373
Intermuscular administration
Dose -3
ASP7373
ASP7373
Intermuscular administration
Interventions
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ASP7373
Intermuscular administration
Placebo
Intramuscular administration
Eligibility Criteria
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Inclusion Criteria
* BMI: ≥17.6, \<26.4
* Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained
Exclusion Criteria
* History of H5 influenza infection or received H5 influenza vaccine
* Past 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)
* 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 or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of the study vaccine
* History of seizures
* Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period
20 Years
40 Years
ALL
Yes
Sponsors
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UMN Pharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Kyushu, , Japan
Countries
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Other Identifiers
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7373-CL-0106
Identifier Type: -
Identifier Source: org_study_id