A Study to Evaluate the Immune Response to the ASP7373 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:
NCT01450579
First received: September 22, 2011
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

This trial is to investigate the clinically recommended dosage for ASP7373 based on the comparison of the immunogenicity and safety among the three doses of ASP7373 in healthy adults.


Condition Intervention Phase
Healthy
Biological: ASP7373
Biological: Placebo
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: Phase II Study of ASP7373 Evaluation of Immunogenicity and Safety of ASP7373 in Healthy Adults

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs [ Time Frame: up to 43 days ] [ Designated as safety issue: No ]
  • Immunogenicity (HI antibody titer)- first vaccine [ Time Frame: on Day 21 ] [ Designated as safety issue: No ]
  • Immunogenicity (HI antibody titer)- second vaccine [ Time Frame: on Day 43 ] [ Designated as safety issue: No ]
    second vaccination on Day 22


Enrollment: 180
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Saline
Biological: Placebo
Intramuscular administration
Experimental: Dose -1
ASP7373
Biological: ASP7373
Intermuscular administration
Experimental: Dose -2
ASP7373
Biological: ASP7373
Intermuscular administration
Experimental: Dose -3
ASP7373
Biological: ASP7373
Intermuscular administration

  Eligibility

Ages Eligible for Study:   20 Years to 40 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 period
  • 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
  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: NCT01450579

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: NCT01450579     History of Changes
Other Study ID Numbers: 7373-CL-0106
Study First Received: September 22, 2011
Last Updated: January 20, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Recombinant Influenza HA vaccine
Immunogenicity of ASP7373

ClinicalTrials.gov processed this record on September 18, 2014