A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine
NCT ID: NCT01201902
Last Updated: 2010-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
592 participants
INTERVENTIONAL
2009-10-31
2010-07-31
Brief Summary
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Detailed Description
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1. Proportion of subjects, stratified by group, with seroconversion to HI antibody
2. Proportion of subjects, stratified by group, achieving a serum hemagglutination inhibition assay(HIA) antibody titer of 1:40 greater against the influenza H1N1 2009 virus
3. GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) measuring by HIA antibody titer
* Safety Outcome Measures :
1\. Solicited adverse events(Day 0 \~ 6, Day 21 \~ 27) 2. Unsolicited adverse events(Day 0 \~ 42) 3. Adverse events(Day 21 \~ 6 months)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group 1 : Low dose with adjuvant
Group 1: 18 \~ 64 years old subjects
Adjuvanted influenza A(H1N1) vaccine
0.25ml, Intramuscular on Day 0 and 21
Group 1: High dose with adjuvant
Group 1: 18 \~ 64 years old subjects
Adjuvanted influenza A(H1N1) vaccine
0.5ml, Intramuscular on Day 0 and 21
Group1 : Plain vaccine
Group 1: 18 \~ 64 years old subjects
un-adjuvanted influenza A(H1N1) vaccine
0.5ml, Intramuscular on Day 0 and 21
Group 2 : Low dose with adjuvant
Group 2: greater than or equal to 65 years of age
Adjuvanted influenza A(H1N1) vaccine
0.25ml, Intramuscular on Day 0 and 21
Group 2 : high dose with adjuvant
Group 2: greater than or equal to 65 years of age
Adjuvanted influenza A(H1N1) vaccine
0.5ml, Intramuscular on Day 0 and 21
Interventions
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Adjuvanted influenza A(H1N1) vaccine
0.25ml, Intramuscular on Day 0 and 21
Adjuvanted influenza A(H1N1) vaccine
0.5ml, Intramuscular on Day 0 and 21
un-adjuvanted influenza A(H1N1) vaccine
0.5ml, Intramuscular on Day 0 and 21
Adjuvanted influenza A(H1N1) vaccine
0.25ml, Intramuscular on Day 0 and 21
Adjuvanted influenza A(H1N1) vaccine
0.5ml, Intramuscular on Day 0 and 21
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are able to understand and comply with planned study procedures.
* Provide written informed consent prior to initiation of any study procedures.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Green Cross Corporation
INDUSTRY
Responsible Party
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Green Cross Corparation
Principal Investigators
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Woo-ju Kim
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Other Identifiers
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임상제도과 - 649호(2009.9.28)
Identifier Type: REGISTRY
Identifier Source: secondary_id
GC1116
Identifier Type: -
Identifier Source: org_study_id