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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01393951
• Other study ID #: 7374-CL-0101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 12, 2011
• Last updated: September 27, 2017
• Start date: May 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 49 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 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

Related Conditions & MeSH terms

• Healthy
• Immunogenicity of ASP7374

Intervention

Biological:
• ASP7374
subcutaneous and intramuscular

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	Immunogenicity: HI antibody titer		Day 29
Primary	Safety: Incidence of Adverse events, vital signs and laboratory tests		28 days post-vaccination