Clinical trial NCT01961947: Study of ASP7374, Cell-culture-derived Influenza Vaccine
Official title: Phase 3 Study of ASP7374 -Approved Egg-derived Vaccine Controlled, Double-blind, Parallel Group Study in Adults ≥20 and <65 Years of Age-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Vaccine
Keywords: ASP7374
Approved egg-derived vaccine
Prevention of seasonal influenza
Lead sponsor: UMN Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-14
Enrollment: 900
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: 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 adults ≥20 and \<65 years.


Eligibility criteria: 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

Primary outcomes:
measure: seroconversion rate of hemagglutination 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 (Day 29/Day 1)
timeFrame: Day1 and Day 29
measure: seroconversion rate of neutralizing antibody titer
timeFrame: Day 29
measure: seroprotection of neutralizing antibody titer
timeFrame: Day 29
measure: GMT of neutralizing antibody titer
timeFrame: Day 29
measure: GMT ratio of neutralizing antibody titer (Day 29/Day 1)
timeFrame: Day 1 and Day 29
measure: Local and systemic reactions associated with the vaccination
timeFrame: Day 1 through Day 8
Other outcomes:
Locations:
city: Kanto
country: Japan
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: PRINCIPAL_INVESTIGATOR
References: