A Study to Evaluate the Immune Response to the ASP7373 and Its Safety in Healthy Adult Volunteers
Phase II Study of ASP7373 Evaluation of Immunogenicity and Safety of ASP7373 in Healthy Adults
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 healthy
Started Jul 2011
Shorter than P25 for phase_2 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 22, 2011
CompletedFirst Posted
Study publicly available on registry
October 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedSeptember 29, 2017
September 1, 2017
5 months
September 22, 2011
September 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs
up to 43 days
Immunogenicity (HI antibody titer)- first vaccine
on Day 21
Immunogenicity (HI antibody titer)- second vaccine
second vaccination on Day 22
on Day 43
Study Arms (4)
Placebo
PLACEBO COMPARATORSaline
Dose -1
EXPERIMENTALASP7373
Dose -2
EXPERIMENTALASP7373
Dose -3
EXPERIMENTALASP7373
Interventions
Eligibility Criteria
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMN Pharma Inc.lead
Study Sites (1)
Unknown Facility
Kyushu, Japan
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
September 22, 2011
First Posted
October 12, 2011
Study Start
July 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
September 29, 2017
Record last verified: 2017-09