Clinical trial NCT01767896: Phase-3 Study of ASP7374, Cell-culture-derived Influenza Vaccine
Official title: Phase III Study of ASP7374 -Approved Egg-derived Vaccine Controlled, Double-blind, Parallel Group Study in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza vaccine
Lead sponsor: UMN Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-15
Enrollment: 1020
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: seroconversion rate of hemoagglutination inhibition (HI) antibody titer
timeFrame: Day 29
measure: geometric mean titer (GMT) of HI antibody titer
timeFrame: Day 29
Secondary outcomes:
measure: seroprotection rate of HI antibody titer
timeFrame: Day 29
measure: GMT ratio of HI antibody titer
timeFrame: Day 1 and Day 29
measure: seroconversion rate of neutralizing antibody titer
timeFrame: Day 29
measure: seroprotection rate of neutralizing antibody titer
timeFrame: Day 29
measure: GMT of neutralizing antibody
timeFrame: Day 29
measure: GMT ratio of neutralizing antibody
timeFrame: Day 1 and Day 29
Other outcomes:
Locations:
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: