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 adults ≥20 and <65 years.

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

Conditions
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Influenza, Vaccine

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: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 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> | Biological: ASP7374<br>* subcutaneous<br>|
| Active Comparator: TIV group<br> | Biological: approved egg-derived TIV<br>* subcutaneous<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 hemagglutination 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 (Day 29/Day 1) | evaluated for A/H1N1, A/H3N2, and B | Day1 and Day 29 | 
| seroconversion rate of neutralizing antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 | 
| seroprotection of neutralizing antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 | 
| GMT of neutralizing antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 | 
| GMT ratio of neutralizing antibody titer (Day 29/Day 1) | evaluated for A/H1N1, A/H3N2, and B | Day 1 and Day 29 | 
| Local and systemic reactions associated with the vaccination |  | Day 1 through Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP7374, Approved egg-derived vaccine, Prevention of seasonal influenza