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A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine

Primary Purpose

Influenza Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Adjuvanted influenza A(H1N1) vaccine
Adjuvanted influenza A(H1N1) vaccine
un-adjuvanted influenza A(H1N1) vaccine
Adjuvanted influenza A(H1N1) vaccine
Adjuvanted influenza A(H1N1) vaccine
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Group 1 : Low dose with adjuvant

    Group 1: High dose with adjuvant

    Group1 : Plain vaccine

    Group 2 : Low dose with adjuvant

    Group 2 : high dose with adjuvant

    Arm Description

    Group 1: 18 ~ 64 years old subjects

    Group 1: 18 ~ 64 years old subjects

    Group 1: 18 ~ 64 years old subjects

    Group 2: greater than or equal to 65 years of age

    Group 2: greater than or equal to 65 years of age

    Outcomes

    Primary Outcome Measures

    HI antibody responses after 1 and/or 2 vaccinations

    Secondary Outcome Measures

    Solicited local & general AE, Unsolicited AE, AE until 6 months after last vaccination

    Full Information

    First Posted
    September 13, 2010
    Last Updated
    September 17, 2010
    Sponsor
    Green Cross Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01201902
    Brief Title
    A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine
    Official Title
    Randomized, Open, Clinical Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine GC1116 With Adjuvant in Healthy Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    December 2009 (Actual)
    Study Completion Date
    July 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Green Cross Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. 354 individuals will be 18-64 years old, and the other 236 will be greater than or equal to 65 years of age.
    Detailed Description
    ▶ Immunogenicity(Efficacy) Outcome Measures : Hemagglutination inhibition assay Proportion of subjects, stratified by group, with seroconversion to HI antibody 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 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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Influenza Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    592 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1 : Low dose with adjuvant
    Arm Type
    Experimental
    Arm Description
    Group 1: 18 ~ 64 years old subjects
    Arm Title
    Group 1: High dose with adjuvant
    Arm Type
    Experimental
    Arm Description
    Group 1: 18 ~ 64 years old subjects
    Arm Title
    Group1 : Plain vaccine
    Arm Type
    Active Comparator
    Arm Description
    Group 1: 18 ~ 64 years old subjects
    Arm Title
    Group 2 : Low dose with adjuvant
    Arm Type
    Experimental
    Arm Description
    Group 2: greater than or equal to 65 years of age
    Arm Title
    Group 2 : high dose with adjuvant
    Arm Type
    Experimental
    Arm Description
    Group 2: greater than or equal to 65 years of age
    Intervention Type
    Biological
    Intervention Name(s)
    Adjuvanted influenza A(H1N1) vaccine
    Other Intervention Name(s)
    Split-virion vaccine
    Intervention Description
    0.25ml, Intramuscular on Day 0 and 21
    Intervention Type
    Biological
    Intervention Name(s)
    Adjuvanted influenza A(H1N1) vaccine
    Other Intervention Name(s)
    Split-virion vaccine
    Intervention Description
    0.5ml, Intramuscular on Day 0 and 21
    Intervention Type
    Biological
    Intervention Name(s)
    un-adjuvanted influenza A(H1N1) vaccine
    Other Intervention Name(s)
    Split-virion vaccine
    Intervention Description
    0.5ml, Intramuscular on Day 0 and 21
    Intervention Type
    Biological
    Intervention Name(s)
    Adjuvanted influenza A(H1N1) vaccine
    Other Intervention Name(s)
    Split-virion vaccine
    Intervention Description
    0.25ml, Intramuscular on Day 0 and 21
    Intervention Type
    Biological
    Intervention Name(s)
    Adjuvanted influenza A(H1N1) vaccine
    Other Intervention Name(s)
    Split-virion vaccine
    Intervention Description
    0.5ml, Intramuscular on Day 0 and 21
    Primary Outcome Measure Information:
    Title
    HI antibody responses after 1 and/or 2 vaccinations
    Time Frame
    21 days after vaccination
    Secondary Outcome Measure Information:
    Title
    Solicited local & general AE, Unsolicited AE, AE until 6 months after last vaccination
    Time Frame
    the date of vaccination until 6 days after vaccination, 42days after first vaccination, 6 months after last vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Woo-ju Kim
    Organizational Affiliation
    Korea University Guro Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine

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