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

UMN Pharma

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: ASP7374

Biological: approved egg-derived TIV

Study type

Interventional

Funder types

Industry

Identifiers

NCT01767896

7374-CL-0103

Details and patient eligibility

About

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.

Enrollment

1,020 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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