Study of ASP7374, Cell-culture-derived Influenza Vaccine

September 27, 2017 updated by: UMN Pharma Inc.

Phase 3 Study of ASP7374 -Approved Egg-derived Vaccine Controlled, Double-blind, Parallel Group Study in Adults ≥20 and <65 Years of Age-

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kanto, Japan
      • Kyushu, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TIV group
Biological: approved egg-derived TIV
subcutaneous
Other Names:
  • Influenza HA vaccine "SEIKEN"
Experimental: ASP7374 group
Biological: ASP7374
subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
seroconversion rate of hemagglutination inhibition (HI) antibody titer
Time Frame: Day 29
evaluated for A/H1N1, A/H3N2, and B
Day 29
geometric mean titer (GMT) of HI antibody titer
Time Frame: Day 29
evaluated for A/H1N1, A/H3N2, and B
Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local and systemic reactions associated with the vaccination
Time Frame: Day 1 through Day 8
Day 1 through Day 8
seroprotection rate of HI antibody titer
Time Frame: Day 29
evaluated for A/H1N1, A/H3N2, and B
Day 29
GMT ratio of HI antibody titer (Day 29/Day 1)
Time Frame: Day1 and Day 29
evaluated for A/H1N1, A/H3N2, and B
Day1 and Day 29
seroconversion rate of neutralizing antibody titer
Time Frame: Day 29
evaluated for A/H1N1, A/H3N2, and B
Day 29
seroprotection of neutralizing antibody titer
Time Frame: Day 29
evaluated for A/H1N1, A/H3N2, and B
Day 29
GMT of neutralizing antibody titer
Time Frame: Day 29
evaluated for A/H1N1, A/H3N2, and B
Day 29
GMT ratio of neutralizing antibody titer (Day 29/Day 1)
Time Frame: Day 1 and Day 29
evaluated for A/H1N1, A/H3N2, and B
Day 1 and Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMN Pharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

October 10, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Actual)

September 29, 2017

Last Update Submitted That Met QC Criteria

September 27, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7374-CL-0102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe