Last updated: 05/13/2024 10:30:09

Evaluation of safety of GlaxoSmithKline (GSK) Vaccines’ quadrivalent seasonal influenza vaccine, Fluarix Tetra when administered according to the approved Prescribing Information (PI) in Korea.

GSK study ID
204687
See study documents
Clinicaltrials.gov ID
NCT02663102
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Assessment of safety of GlaxoSmithKline (GSK) Vaccines’ quadrivalent seasonal influenza vaccine, Fluarix Tetra when administered according to the approved Prescribing Information in Korea.
Trial description: The purpose of this study is to collect safety information on the use of Fluarix Tetra according to the approved PI, in Korea, over a period of 6 years from children greater than or equal to (≥)3 years of age and adults, and over a period of 4 years from children between 6 months and 35 months of age.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with expected adverse events (AEs)

Timeframe: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)

Number of participants with unexpected adverse events (AEs)

Timeframe: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)

Number of participants with serious adverse events (SAEs)

Timeframe: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data collection
    • Enrollment:
    1388
    Primary completion date:
    2021-05-02
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Gaël Dos Santos, Raghavendra Devadiga, Chun Soo Kim, Joon Bang. EPI_EPI-FLU-050 VS KR PMS_ An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014-2022) Following the Introduction of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older_(AR). Drug Saf. DOI: 10.1007/s40264-024-01395-8 PMID: 38483767
    Medical condition
    Influenza, Human
    Product
    GSK2321138A, GSK2647158A
    Collaborators
    Not applicable
    Study date(s)
    October 2016 to February 2021
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    6+ years
    Accepts healthy volunteers
    Yes
    • Male or female subjects who were vaccinated with Fluarix Tetra or eligible to receive Fluarix Tetra according to the locally approved PI.
    • Signed informed consent as Informed Consent Form (ICF)/Informed Assent Form (IAF) obtained from the subject/subject’s parent(s)/Legally acceptable Representative(s) [LAR(s)].
    • Those who are not eligible for vaccination with Fluarix Tetra according to the local PI.
    • ‒ Hypersensitivity reaction to Fluarix Tetra.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Male or female subjects who were vaccinated with Fluarix Tetra or eligible to receive Fluarix Tetra according to the locally approved PI.

      • Signed informed consent as Informed Consent Form (ICF)/Informed Assent Form (IAF) obtained from the subject/subject’s parent(s)/Legally acceptable Representative(s) [LAR(s)].
    Exclusion criteria:

      Those who are not eligible for vaccination with Fluarix Tetra according to the local PI. ‒ Hypersensitivity reaction to Fluarix Tetra. ‒ History of hypersensitivity reaction to Influenza vaccine. ‒ History of Guillain-Barre syndrome or other nervous system abnormalities to Influenza vaccine within 6 weeks post-vaccination.

      • Those who are not eligible for vaccination with Fluarix Tetra according to the medical judgement of physician.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Seoul, South Korea, 03722
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Daegu, South Korea, 700 712
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Daegu-si, South Korea, 42601
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Incheon, South Korea, 22214
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ulsan, South Korea, 683380
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Yangju-si, Gyeonggi-do, South Korea, 11456
    Status
    Study Complete
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    Showing 1 - 6 of 12 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2021-05-02
    Actual study completion date
    2021-05-02

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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