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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767896
• Other study ID #: 7374-CL-0103
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2013
• Last updated: September 27, 2017
• Start date: October 2012
• Est. completion date: March 2013

Study information

• Verified date: September 2017
• Source: UMN Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1020
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• ASP7374
subcutaneous (sc)
• approved egg-derived TIV
subcutaneous (sc)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UMN Pharma Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seroconversion rate of hemoagglutination inhibition (HI) antibody titer	evaluated for A/H1N1, A/H3N2, and B	Day 29
Primary	geometric mean titer (GMT) of HI antibody titer	evaluated for A/H1N1, A/H3N2, and B	Day 29
Secondary	seroprotection rate of HI antibody titer	evaluated for A/H1N1, A/H3N2, and B	Day 29
Secondary	GMT ratio of HI antibody titer	evaluated for A/H1N1, A/H3N2, and B	Day 1 and Day 29
Secondary	seroconversion rate of neutralizing antibody titer	evaluated for A/H1N1, A/H3N2, and B	Day 29
Secondary	seroprotection rate of neutralizing antibody titer	evaluated for A/H1N1, A/H3N2, and B	Day 29
Secondary	GMT of neutralizing antibody	evaluated for A/H1N1, A/H3N2, and B	Day 29
Secondary	GMT ratio of neutralizing antibody	evaluated for A/H1N1, A/H3N2, and B	Day 1 and Day 29