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

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: ASP7374; Biological: approved egg-derived TIV

• Registration Number: NCT01767896
• Lead Sponsor: UMN Pharma Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-11
• Study First Posted: 2013-01-15
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1020

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASP7374 group	ASP7374	cell-culture-derived vaccine group
TIV group	approved egg-derived TIV	approved egg-derived TIV group

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
seroprotection rate of HI antibody titer	Day 29	evaluated for A/H1N1, A/H3N2, and B
GMT ratio of HI antibody titer	Day 1 and Day 29	evaluated for A/H1N1, A/H3N2, and B
seroconversion rate of neutralizing antibody titer	Day 29	evaluated for A/H1N1, A/H3N2, and B
seroprotection rate of neutralizing antibody titer	Day 29	evaluated for A/H1N1, A/H3N2, and B
GMT of neutralizing antibody	Day 29	evaluated for A/H1N1, A/H3N2, and B
GMT ratio of neutralizing antibody	Day 1 and Day 29	evaluated for A/H1N1, A/H3N2, and B