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

This study has been completed.
Sponsor:
Collaborator:
UMN Pharma Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01393951
First received: July 12, 2011
Last updated: January 20, 2012
Last verified: January 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Astellas Pharma Inc:

Primary Outcome Measures:
  • Immunogenicity: HI antibody titer [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • Safety: Incidence of Adverse events, vital signs and laboratory tests [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 49 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393951

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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01393951     History of Changes
Other Study ID Numbers: 7374-CL-0101
Study First Received: July 12, 2011
Last Updated: January 20, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Recombinant Influenza hemagglutinin vaccine

ClinicalTrials.gov processed this record on October 19, 2014