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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01767896

Enrollment

1020

Registered

2013-01-15

Start date

2012-10-31

Completion date

2013-03-31

Last updated

2017-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza vaccine

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.

Interventions

BIOLOGICALASP7374

subcutaneous (sc)

BIOLOGICALapproved egg-derived TIV

subcutaneous (sc)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
seroconversion rate of hemoagglutination inhibition (HI) antibody titer	Day 29	evaluated for A/H1N1, A/H3N2, and B
geometric mean titer (GMT) of HI antibody titer	Day 29	evaluated for A/H1N1, A/H3N2, and B

Secondary

Measure	Time frame	Description
seroconversion rate of neutralizing antibody titer	Day 29	evaluated for A/H1N1, A/H3N2, and B
seroprotection rate of neutralizing antibody titer	Day 29	evaluated for A/H1N1, A/H3N2, and B
seroprotection rate of HI antibody titer	Day 29	evaluated for A/H1N1, A/H3N2, and B
GMT ratio of neutralizing antibody	Day 1 and Day 29	evaluated for A/H1N1, A/H3N2, and B
GMT of neutralizing antibody	Day 29	evaluated for A/H1N1, A/H3N2, and B
GMT ratio of HI antibody titer	Day 1 and Day 29	evaluated for A/H1N1, A/H3N2, and B

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026