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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: ASP7374; Biological: approved egg-derived TIV

• Study Type: Interventional
• Enrollment (Actual): 1020
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Kansai, Japan
  • Kantou, Japan
  • Kyushu, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Influenza HA vaccine "SEIKEN"

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
seroprotection rate of HI antibody titer	evaluated for A/H1N1, A/H3N2, and B	Day 29
seroconversion rate of neutralizing antibody titer	evaluated for A/H1N1, A/H3N2, and B	Day 29
GMT ratio of HI antibody titer	evaluated for A/H1N1, A/H3N2, and B	Day 1 and Day 29
seroprotection rate of neutralizing antibody titer	evaluated for A/H1N1, A/H3N2, and B	Day 29
GMT of neutralizing antibody	evaluated for A/H1N1, A/H3N2, and B	Day 29
GMT ratio of neutralizing antibody	evaluated for A/H1N1, A/H3N2, and B	Day 1 and Day 29

Collaborators and Investigators

• Sponsor: UMN Pharma Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: January 11, 2013
• First Submitted That Met QC Criteria: January 11, 2013
• First Posted (Estimate): January 15, 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: Influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 7374-CL-0103