A Study to Evaluate the Immune Response to the ASP7373 and Its Safety in Healthy Adult Volunteers

Study Overview
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Brief Summary
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This trial is to investigate the clinically recommended dosage for ASP7373 based on the comparison of the immunogenicity and safety among the three doses of ASP7373 in healthy adults.

Official Title
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Phase II Study of ASP7373 Evaluation of Immunogenicity and Safety of ASP7373 in Healthy Adults

Conditions
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Healthy

Intervention / Treatment
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* Biological: ASP7373
* Biological: Placebo


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 period History of H5 influenza infection or received H5 influenza vaccine 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) 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 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 History of seizures 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: 40 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline | Biological: Placebo<br>* Intramuscular administration<br>|
| Experimental: Dose -1<br>ASP7373 | Biological: ASP7373<br>* Intermuscular administration<br>|
| Experimental: Dose -2<br>ASP7373 | Biological: ASP7373<br>* Intermuscular administration<br>|
| Experimental: Dose -3<br>ASP7373 | Biological: ASP7373<br>* Intermuscular administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs |  | up to 43 days | 
| Immunogenicity (HI antibody titer)- first vaccine |  | on Day 21 | 
| Immunogenicity (HI antibody titer)- second vaccine | second vaccination on Day 22 | on Day 43 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recombinant Influenza HA vaccine, Immunogenicity of ASP7373