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

NCT01393951 | Completed Phase 1

• 1 other identifier: 7374-CL-0101
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Immunogenicity of ASP7374

Keywords

Recombinant Influenza hemagglutinin vaccine

Outcome Measures

Primary Outcomes (2)

• Immunogenicity: HI antibody titer

  Day 29

• Safety: Incidence of Adverse events, vital signs and laboratory tests

  28 days post-vaccination

Study Arms (3)

sc dose 1

EXPERIMENTAL

subcutaneous (sc) vaccination of ASP7374 dose-1

Biological: ASP7374

sc dose 2

EXPERIMENTAL

subcutaneous vaccination of ASP7374 dose-2

Biological: ASP7374

im dose 3

EXPERIMENTAL

intramuscular (im) vaccination of ASP7374 dose-3

Biological: ASP7374

Interventions

ASP7374 BIOLOGICAL

subcutaneous and intramuscular

im dose 3; sc dose 1; sc dose 2

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMN Pharma Inc.: lead

Study Sites (1)

Unknown Facility

Kyushu, Japan

Location

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 14, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

JP (1)