A Study to Evaluate the Immune Response to the ASP7374 and Its Safety in Healthy Adult Volunteers

Study Overview
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Brief Summary
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This trial is designed as a blinded, randomized and parallel group study to investigate the clinically recommended dosage for ASP7374 based on the comparison of the immunogenicity and safety among two doses of subcutaneous ASP7374 and one dose of intramuscular ASP7374 in healthy adults.

Official Title
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Study for Immunogenicity and Safety of ASP7374 for Subcutaneous and Intramuscular Vaccination in Healthy Adults

Conditions
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Healthy, Immunogenicity of ASP7374

Intervention / Treatment
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* Biological: ASP7374


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight: Female: ≥40.0 kg, <70.0 kg, Male: ≥50.0 kg, <80.0 kg BMI: ≥17.6, <26.4 Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained Exclusion Criteria: Scheduled to receive another vaccine during study participation period Received influenza vaccine within 180 days prior to the study Received or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of 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 Past 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) Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 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: sc dose 1<br>subcutaneous (sc) vaccination of ASP7374 dose-1 | Biological: ASP7374<br>* subcutaneous and intramuscular<br>|
| Experimental: sc dose 2<br>subcutaneous vaccination of ASP7374 dose-2 | Biological: ASP7374<br>* subcutaneous and intramuscular<br>|
| Experimental: im dose 3<br>intramuscular (im) vaccination of ASP7374 dose-3 | Biological: ASP7374<br>* subcutaneous and intramuscular<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity: HI antibody titer |  | Day 29 | 
| Safety: Incidence of Adverse events, vital signs and laboratory tests |  | 28 days post-vaccination | 

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