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

UMN Pharma

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Biological: Placebo; Biological: ASP7373

Study type: Interventional

Funder types: Industry

Identifiers

NCT01450579

7373-CL-0106

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Saline

Treatment:

Biological: Placebo

Dose -1

Experimental group

Description:

ASP7373

Treatment:

Biological: ASP7373

Dose -2

Experimental group

Description:

ASP7373

Treatment:

Biological: ASP7373

Dose -3

Experimental group

Description:

ASP7373

Treatment:

Biological: ASP7373