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Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
FluarixTM
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Korea, FluarixTM

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A male or female > 6 months of age at the time of the first vaccination.
  • Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • Free of obvious health problems as established by medical history and clinical examination judged by the investigator before entering into the study.
  • If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.

Exclusion Criteria:

  • Clinical signs of acute febrile illness at the time of entry into the study.
  • Any treatment with immunosuppressive drugs, including oral and parenteral corticosteroids.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or previous severe reaction to influenza virus vaccine.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Unprimed, > 6 to < 72 Months

    Unprimed, ≥ 72 to < 108 Months

    Primed, > 6 to < 72 Months

    Primed, ≥ 72 to < 108 Months

    Primed, ≥ 108 to < 216 Months

    Primed, ≥ 216 Months

    Arm Description

    Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).

    Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).

    Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).

    Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).

    Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).

    Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).

    Outcomes

    Primary Outcome Measures

    Number of Participants Reporting Severe Unsolicited Adverse Events
    An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities

    Secondary Outcome Measures

    Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.
    Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.
    Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.
    Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis.
    Number of Participant Reporting Unsolicited Adverse Events.
    An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    Number of Participants Reporting Serious Adverse Events (SAE).
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

    Full Information

    First Posted
    September 9, 2008
    Last Updated
    October 8, 2018
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00750360
    Brief Title
    Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.
    Official Title
    Study to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Influenza Split Vaccine FLUARIX™ Administered According to the Prescribing Information in Korean Subjects Aged More Than 6 Months of Age at the Time of Vaccination
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 3, 2003 (undefined)
    Primary Completion Date
    December 1, 2007 (Actual)
    Study Completion Date
    December 28, 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    5. Study Description

    Brief Summary
    The present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of Korean Food and Drugs Administration (KFDA).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    883 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Unprimed, > 6 to < 72 Months
    Arm Type
    Experimental
    Arm Description
    Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
    Arm Title
    Unprimed, ≥ 72 to < 108 Months
    Arm Type
    Experimental
    Arm Description
    Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
    Arm Title
    Primed, > 6 to < 72 Months
    Arm Type
    Experimental
    Arm Description
    Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
    Arm Title
    Primed, ≥ 72 to < 108 Months
    Arm Type
    Experimental
    Arm Description
    Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
    Arm Title
    Primed, ≥ 108 to < 216 Months
    Arm Type
    Experimental
    Arm Description
    Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
    Arm Title
    Primed, ≥ 216 Months
    Arm Type
    Experimental
    Arm Description
    Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
    Intervention Type
    Biological
    Intervention Name(s)
    FluarixTM
    Intervention Description
    All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).
    Primary Outcome Measure Information:
    Title
    Number of Participants Reporting Severe Unsolicited Adverse Events
    Description
    An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities
    Time Frame
    During the 21-day follow-up period (Day 0 to Day 20) after vaccination
    Secondary Outcome Measure Information:
    Title
    Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.
    Description
    Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.
    Time Frame
    During the 4-day follow up (Day 0 to 3) after vaccination.
    Title
    Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.
    Description
    Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis.
    Time Frame
    During the 4-day follow up (Day 0 to 3) after vaccination.
    Title
    Number of Participant Reporting Unsolicited Adverse Events.
    Description
    An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    Time Frame
    During the 21-day follow-up period (Day 0 to Day 20) after vaccination
    Title
    Number of Participants Reporting Serious Adverse Events (SAE).
    Description
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    Time Frame
    Within 1 month following vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: A male or female > 6 months of age at the time of the first vaccination. Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. Free of obvious health problems as established by medical history and clinical examination judged by the investigator before entering into the study. If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination. Exclusion Criteria: Clinical signs of acute febrile illness at the time of entry into the study. Any treatment with immunosuppressive drugs, including oral and parenteral corticosteroids. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or previous severe reaction to influenza virus vaccine.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
    Links:
    URL
    https://www.clinicalstudydatarequest.com
    Description
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Statistical Analysis Plan
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    218352/054
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Dataset Specification
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    218352/054
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Informed Consent Form
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    218352/054
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Clinical Study Report
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    218352/054
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    218352/054
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Individual Participant Data Set
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    218352/054
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register

    Learn more about this trial

    Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.

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