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Phase IV Clinical Trial of an Influenza Split Vaccine Anflu

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
seasonal split influenza vaccine
seasonal split influenza vaccine
seasonal split influenza vaccine
seasonal split influenza vaccine
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults aged 18-60 years old
  • Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years
  • Not participate in any other clinical trials during the study
  • Not receive any immunosuppressive agents during and one month prior to the study
  • Be able to understand and sign the informed consent.

Exclusion Criteria:

  • Woman: Who breast-feeding or planning to become pregnant during the study
  • Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin
  • Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  • Autoimmune disease or immunodeficiency
  • Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases
  • Guillain-Barre Syndrome
  • Women subjects with positive urinary pregnancy test
  • Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
  • Axillary temperature >37.0 centigrade at the time of dosing
  • Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
  • Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    1: Lot 1

    2: Lot 2

    3: Lot 3

    4: control vaccine

    Arm Description

    Outcomes

    Primary Outcome Measures

    Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B

    Secondary Outcome Measures

    local and systematic adverse reactions after vaccination

    Full Information

    First Posted
    November 8, 2007
    Last Updated
    November 8, 2007
    Sponsor
    Sinovac Biotech Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00556062
    Brief Title
    Phase IV Clinical Trial of an Influenza Split Vaccine Anflu
    Official Title
    The Clinical Trial for Three Consecutive Lots of Influenza Split Vaccine Anflu by Randomized, Double-Blind and Controlled Design
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2007 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sinovac Biotech Co., Ltd

    4. Oversight

    5. Study Description

    Brief Summary
    To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    566 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1: Lot 1
    Arm Type
    Experimental
    Arm Title
    2: Lot 2
    Arm Type
    Experimental
    Arm Title
    3: Lot 3
    Arm Type
    Experimental
    Arm Title
    4: control vaccine
    Arm Type
    Active Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    seasonal split influenza vaccine
    Intervention Description
    0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
    Intervention Type
    Biological
    Intervention Name(s)
    seasonal split influenza vaccine
    Intervention Description
    0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
    Intervention Type
    Biological
    Intervention Name(s)
    seasonal split influenza vaccine
    Intervention Description
    0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
    Intervention Type
    Biological
    Intervention Name(s)
    seasonal split influenza vaccine
    Intervention Description
    0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
    Primary Outcome Measure Information:
    Title
    Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B
    Time Frame
    0, 21 days
    Secondary Outcome Measure Information:
    Title
    local and systematic adverse reactions after vaccination
    Time Frame
    within 3 days after vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy adults aged 18-60 years old Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years Not participate in any other clinical trials during the study Not receive any immunosuppressive agents during and one month prior to the study Be able to understand and sign the informed consent. Exclusion Criteria: Woman: Who breast-feeding or planning to become pregnant during the study Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain Autoimmune disease or immunodeficiency Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases Guillain-Barre Syndrome Women subjects with positive urinary pregnancy test Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis) Axillary temperature >37.0 centigrade at the time of dosing Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhilun Zhang
    Organizational Affiliation
    Tianjin centers for Disease Control and Prevention
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Phase IV Clinical Trial of an Influenza Split Vaccine Anflu

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