Status:
COMPLETED
A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine
Lead Sponsor:
Green Cross Corporation
Conditions:
Influenza Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and the body's immune response to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 590 hea...
Detailed Description
▶ Immunogenicity(Efficacy) Outcome Measures : Hemagglutination inhibition assay 1. Proportion of subjects, stratified by group, with seroconversion to HI antibody 2. Proportion of subjects, stratifie...
Eligibility Criteria
Inclusion
- Healthy adults age 18 and older.
- Are able to understand and comply with planned study procedures.
- Provide written informed consent prior to initiation of any study procedures.
Exclusion
- Have a known allergy to eggs, chickens or other components of the vaccine(including MF59).
- Have immunosuppression including immunodeficiency disease.
- Have a history of Guillain-Barre Syndrome.
- Have a diagnosis of thrombocytopenia.
- Have a chronic disease that the investigator believes may interfere with successful completion of the study. (Excluding regulating hypertension)
- Hemophilia Patients or Are receiving anti-coagulating agents. Low-dose aspirin (100mg/day) purpose of prevention is allowed.
- Are receiving anti-viral agents.
- Have an acute fever, a temperature greater than 38℃(100.4 degrees Fahrenheit) within 72 hours of vaccination or Have a symptom of acute febrile illness within 14 days prior to vaccination in this study.
- Received below agents or expect to receive agents within following periods. A. Have immunosuppression therapy, radiotherapy, use of high-dose glucocorticoids or prednisolone(≥15mg/day) within 6 months prior to vaccination in this study.Inhaled, nasal and topical steroids are allowed) B. Have a history of receiving immunoglobulin or other blood product within 3 months prior to vaccination in this study.
- C. Received an experimental agent within 1 month prior to vaccination in this study.
- D. Received any vaccines(live licensed and inactivated licensed) within 1 month prior to vaccination in this study. (Excluding seasonal Influenza vaccine)
- Those who are not eligible to receive vaccine injection in the arm deltoid muscle.
- Pregnant females, Nursing mom, Those women who have a chance to become pregnant, but not taking a proper contraception.
- Not agree to abstain from drinking following 7 days of vaccination.
- Have any condition (clinically regardful medical or psychological condition) that would, in the opinion of the site investigator, render them unable to meet the requirements of the protocol.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
592 Patients enrolled
Trial Details
Trial ID
NCT01201902
Start Date
October 1 2009
End Date
July 1 2010
Last Update
September 20 2010
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