Status:
COMPLETED
A Study to Evaluate the Immune Response to the ASP7373 and Its Safety in Healthy Adult Volunteers
Lead Sponsor:
UMN Pharma Inc.
Conditions:
Healthy
Eligibility:
All Genders
20-40 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01450579
Start Date
July 1 2011
End Date
December 1 2011
Last Update
September 29 2017
Active Locations (1)
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1
Kyushu, Japan