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

NCT01767896 | Completed Phase 3

• 1 other identifier: 7374-CL-0103
• Study Type: interventional
• Target: 1,020
• Locations: 1 country
• Sites: 3

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.

Conditions

Influenza

Keywords

Influenza vaccine

Outcome Measures

Primary Outcomes (2)

• seroconversion rate of hemoagglutination inhibition (HI) antibody titer

  evaluated for A/H1N1, A/H3N2, and B

  Day 29

• geometric mean titer (GMT) of HI antibody titer

  evaluated for A/H1N1, A/H3N2, and B

  Day 29

Secondary Outcomes (6)

• seroprotection rate of HI antibody titer

  Day 29

• GMT ratio of HI antibody titer

  Day 1 and Day 29

• seroconversion rate of neutralizing antibody titer

  Day 29

• seroprotection rate of neutralizing antibody titer

  Day 29

• GMT of neutralizing antibody

  Day 29

Study Arms (2)

ASP7374 group

EXPERIMENTAL

cell-culture-derived vaccine group

Biological: ASP7374

TIV group

ACTIVE COMPARATOR

approved egg-derived TIV group

Biological: approved egg-derived TIV

Interventions

ASP7374 BIOLOGICAL

subcutaneous (sc)

ASP7374 group

approved egg-derived TIV BIOLOGICAL

subcutaneous (sc)

Also known as: Influenza HA vaccine "SEIKEN"

TIV group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMN Pharma Inc.: lead

Study Sites (3)

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 15, 2013
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

JP (3)