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A Study to Evaluate the Immune Response to the ASP7374 and Its Safety in Healthy Adult Volunteers

NCT ID: NCT01393951

Last Updated: 2017-09-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

Brief Summary

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This trial is designed as a blinded, randomized and parallel group study to investigate the clinically recommended dosage for ASP7374 based on the comparison of the immunogenicity and safety among two doses of subcutaneous ASP7374 and one dose of intramuscular ASP7374 in healthy adults.

Detailed Description

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Conditions

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Healthy Immunogenicity of ASP7374

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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sc dose 1

subcutaneous (sc) vaccination of ASP7374 dose-1

Group Type EXPERIMENTAL

ASP7374

Intervention Type BIOLOGICAL

subcutaneous and intramuscular

sc dose 2

subcutaneous vaccination of ASP7374 dose-2

Group Type EXPERIMENTAL

ASP7374

Intervention Type BIOLOGICAL

subcutaneous and intramuscular

im dose 3

intramuscular (im) vaccination of ASP7374 dose-3

Group Type EXPERIMENTAL

ASP7374

Intervention Type BIOLOGICAL

subcutaneous and intramuscular

Interventions

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ASP7374

subcutaneous and intramuscular

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Body weight: Female: ≥40.0 kg, \<70.0 kg, Male: ≥50.0 kg, \<80.0 kg
* 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

* Scheduled to receive another vaccine during study participation period
* Received influenza vaccine within 180 days prior to the study
* 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
* Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome
* 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)
* Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period
Minimum Eligible Age

20 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UMN Pharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Kyushu, , Japan

Site Status

Countries

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Japan

Other Identifiers

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7374-CL-0101

Identifier Type: -

Identifier Source: org_study_id