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

Study Overview
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Brief Summary
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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.

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

Conditions
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Influenza

Intervention / Treatment
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* Biological: ASP7374
* Biological: approved egg-derived TIV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP7374 group<br>cell-culture-derived vaccine group | Biological: ASP7374<br>* subcutaneous (sc)<br>|
| Active Comparator: TIV group<br>approved egg-derived TIV group | Biological: approved egg-derived TIV<br>* subcutaneous (sc)<br>* Other names: Influenza HA vaccine SEIKEN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza vaccine