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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Immunogenicity of ASP7374
• Intervention / Treatment: Biological: ASP7374

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kyushu, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sc dose 1; subcutaneous (sc) vaccination of ASP7374 dose-1	Biological: ASP7374; subcutaneous and intramuscular
Experimental: sc dose 2; subcutaneous vaccination of ASP7374 dose-2	Biological: ASP7374; subcutaneous and intramuscular
Experimental: im dose 3; intramuscular (im) vaccination of ASP7374 dose-3	Biological: ASP7374; subcutaneous and intramuscular

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: UMN Pharma Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 12, 2011
• First Submitted That Met QC Criteria: July 12, 2011
• First Posted (Estimate): July 14, 2011

Study Record Updates

• Last Update Posted (Actual): September 29, 2017
• Last Update Submitted That Met QC Criteria: September 27, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Recombinant Influenza hemagglutinin vaccine
• Other Study ID Numbers: 7374-CL-0101