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
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
2021-05-02
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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Location
GSK Investigational Site
Busan, South Korea, 47545
Status
Study Complete
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Location
GSK Investigational Site
Gwangmyeong, South Korea, 484 5
Status
Study Complete
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Location
GSK Investigational Site
Seoul, South Korea, 138201
Status
Study Complete
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Location
GSK Investigational Site
Gyeongsangbuk-do, South Korea, 39230
Status
Study Complete
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Location
GSK Investigational Site
Suwon-si, Gyeonggi-do, South Korea, 16388
Status
Study Complete
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Location
GSK Investigational Site
Donghae, South Korea, 25768
Status
Study Complete
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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
Finalized
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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