Study of ASP7374, Cell-culture-derived Influenza Vaccine

Phase 3 Study of ASP7374 -Approved Egg-derived Vaccine Controlled, Double-blind, Parallel Group Study in Adults ≥20 and <65 Years of Age-

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01961947

Enrollment

900

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, Approved egg-derived vaccine, Prevention of seasonal influenza

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.

Interventions

BIOLOGICALASP7374

subcutaneous

BIOLOGICALapproved egg-derived TIV

subcutaneous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

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. * 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

Design outcomes

Primary

Measure	Time frame	Description
seroconversion rate of hemagglutination 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 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 titer (Day 29/Day 1)	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	—
GMT of neutralizing antibody titer	Day 29	evaluated for A/H1N1, A/H3N2, and B
GMT ratio of HI antibody titer (Day 29/Day 1)	Day1 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