Phase-3 Study of ASP7374, Cell-culture-derived Influenza Vaccine

This study has been completed.
Sponsor:
Collaborator:
UMN Pharma Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01767896
First received: January 11, 2013
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine (TIV) in elderly subjects.


Condition Intervention Phase
Influenza
Biological: ASP7374
Biological: approved egg-derived TIV
Phase 3

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 III Study of ASP7374 -Approved Egg-derived Vaccine Controlled, Double-blind, Parallel Group Study in Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • seroconversion rate of hemoagglutination inhibition (HI) antibody titer [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    evaluated for A/H1N1, A/H3N2, and B

  • geometric mean titer (GMT) of HI antibody titer [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    evaluated for A/H1N1, A/H3N2, and B


Secondary Outcome Measures:
  • seroprotection rate of HI antibody titer [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    evaluated for A/H1N1, A/H3N2, and B

  • GMT ratio of HI antibody titer [ Time Frame: Day 1 and Day 29 ] [ Designated as safety issue: No ]
    evaluated for A/H1N1, A/H3N2, and B

  • seroconversion rate of neutralizing antibody titer [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    evaluated for A/H1N1, A/H3N2, and B

  • seroprotection rate of neutralizing antibody titer [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    evaluated for A/H1N1, A/H3N2, and B

  • GMT of neutralizing antibody [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    evaluated for A/H1N1, A/H3N2, and B

  • GMT ratio of neutralizing antibody [ Time Frame: Day 1 and Day 29 ] [ Designated as safety issue: No ]
    evaluated for A/H1N1, A/H3N2, and B


Enrollment: 1020
Study Start Date: October 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP7374 group
cell-culture-derived vaccine group
Biological: ASP7374
subcutaneous (sc)
Active Comparator: TIV group
approved egg-derived TIV group
Biological: approved egg-derived TIV
subcutaneous (sc)
Other Name: Influenza HA vaccine "SEIKEN"

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Medically stable, as judged on the basis of history and concurrent diseases
  • Subject understands procedure of the protocol and is willing to comply with the protocol

Exclusion Criteria:

  • Scheduled to receive another vaccine during the study
  • Received influenza HA vaccine within 180 days prior to screening
  • Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with 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
  • Received one of the following medications or treatment prior to vaccination with the study vaccine: Interferon formulation, drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, human immunoglobulin products, blood products
  • 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)
  • History of seizures
  • History of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM)
  • Confirmed diagnosis of influenza within 84 days prior to screening test
  • Body temperature of ≥37.5°C on Day 1 (before vaccination)
  • Immunological tests reveal positive HBs antigen, HCV antibody, and HIV antigen and/or antibody
  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: NCT01767896

Locations
Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
UMN Pharma Inc.
Investigators
Study Director: Medical Director Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01767896     History of Changes
Other Study ID Numbers: 7374-CL-0103
Study First Received: January 11, 2013
Last Updated: July 8, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014