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:
NCT01961947
First received: October 10, 2013
Last updated: November 26, 2013
Last verified: November 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 adults ≥20 and <65 years.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 3 Study of ASP7374 -Approved Egg-derived Vaccine Controlled, Double-blind, Parallel Group Study in Adults ≥20 and <65 Years of Age-

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • seroconversion rate of hemagglutination 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 (Day 29/Day 1) [ Time Frame: Day1 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 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 titer [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    evaluated for A/H1N1, A/H3N2, and B

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

  • Local and systemic reactions associated with the vaccination [ Time Frame: Day 1 through Day 8 ] [ Designated as safety issue: No ]

Enrollment: 900
Study Start Date: October 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP7374 group Biological: ASP7374
subcutaneous
Active Comparator: TIV group Biological: approved egg-derived TIV
subcutaneous
Other Name: Influenza HA vaccine "SEIKEN"

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy or 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.
  • Written informed consent has been obtained.

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.
  • 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, Blood transfusion
  • History of anaphylactic shock or an allergic reaction such as generalized eruption due to food (including chicken, poultry, foodstuffs derived from chicken, et al.) or drug (including vaccines) allergies, fever ≥39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
  • History of seizures, except for febrile seizures in childhood
  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: NCT01961947

Locations
Japan
Kanto, Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
UMN Pharma Inc.
Investigators
Principal Investigator: Medical Director Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01961947     History of Changes
Other Study ID Numbers: 7374-CL-0102
Study First Received: October 10, 2013
Last Updated: November 26, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ASP7374
Approved egg-derived vaccine
Prevention of seasonal influenza

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

ClinicalTrials.gov processed this record on October 22, 2014