A Study to Evaluate Intramuscular ASP7374

Phase 3 Study of ASP7374 -Open-label Study of Intramuscular ASP7374 in Adults ≥61 Years of Age-

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01961960

Enrollment

Registered

2013-10-14

Start date

2013-10-31

Completion date

2013-11-30

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, Vaccine

Keywords

ASP7374, Prevention of seasonal influenza

Brief summary

The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374 in adults ≥61 years of age.

Interventions

BIOLOGICALASP7374

intramuscular

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

61 Years to No maximum

Healthy volunteers

Yes

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: 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 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

Design outcomes

Primary

Measure	Time frame	Description
hemagglutination inhibition (HI) antibody titer	Day 1 and Day 29	evaluated for A/H1N1, A/H3N2, and B

Secondary

Measure	Time frame	Description
neutralizing antibody titer	Day 1 and Day 29	evaluated for A/H1N1, A/H3N2, and B
Local and systemic reactions associated with the vaccination	Day 1 through Day 8	—

Countries

Japan

Outcome results

None listed

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