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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01393951
First Posted: July 14, 2011
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UMN Pharma Inc.
  Purpose
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.

Condition Intervention Phase
Healthy Immunogenicity of ASP7374 Biological: ASP7374 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study for Immunogenicity and Safety of ASP7374 for Subcutaneous and Intramuscular Vaccination in Healthy Adults

Further study details as provided by UMN Pharma Inc.:

Primary Outcome Measures:
  • Immunogenicity: HI antibody titer [ Time Frame: Day 29 ]
  • Safety: Incidence of Adverse events, vital signs and laboratory tests [ Time Frame: 28 days post-vaccination ]

Enrollment: 165
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sc dose 1
subcutaneous (sc) vaccination of ASP7374 dose-1
Biological: ASP7374
subcutaneous and intramuscular
Experimental: sc dose 2
subcutaneous vaccination of ASP7374 dose-2
Biological: ASP7374
subcutaneous and intramuscular
Experimental: im dose 3
intramuscular (im) vaccination of ASP7374 dose-3
Biological: ASP7374
subcutaneous and intramuscular

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393951


Locations
Japan
Kyushu, Japan
Sponsors and Collaborators
UMN Pharma Inc.
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Responsible Party: UMN Pharma Inc.
ClinicalTrials.gov Identifier: NCT01393951     History of Changes
Other Study ID Numbers: 7374-CL-0101
First Submitted: July 12, 2011
First Posted: July 14, 2011
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by UMN Pharma Inc.:
Recombinant Influenza hemagglutinin vaccine

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs