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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450579
• Other study ID #: 7373-CL-0106
• Status: Completed
• Phase: Phase 2
• First received: September 22, 2011
• Last updated: September 27, 2017
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2017
• Source: UMN Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• ASP7373
Intermuscular administration
• Placebo
Intramuscular administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UMN Pharma Inc.

Country where clinical trial is conducted

Japan, 

Outcome

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