Last updated: 11/07/2018 13:22:36
Study to monitor the safety and reactogenicity of Fluarix™ in Korean subjects aged > 6 months of age.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of participants reporting severe unsolicited adverse events
Timeframe: During the 21-day follow-up period (Day 0 to Day 20) after vaccination
Secondary outcomes:
Number of participants reporting solicited local and general adverse events in subjects aged less than 72 months.
Timeframe: During the 4-day follow up (Day 0 to 3) after vaccination.
Number of participants reporting solicited local and general adverse events in subjects aged 72 months and older.
Timeframe: During the 4-day follow up (Day 0 to 3) after vaccination.
Number of participant reporting unsolicited adverse events.
Timeframe: During the 21-day follow-up period (Day 0 to Day 20) after vaccination
Number of participants reporting serious adverse events (SAE).
Timeframe: Within 1 month following vaccination
Interventions:
Enrollment:
883
Primary completion date:
2007-28-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Huh JW et al. (2011) Post-marketing surveillance study of an inactivated split-virion influenza vaccine with diary cards in Korea. Korean J Pediatr Infect Dis. 18(1):68-79.
Medical condition
Influenza
Product
SB218352
Collaborators
Not applicable
Study date(s)
October 2003 to December 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
6+ years
Accepts healthy volunteers
Yes
- 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.
- Clinical signs of acute febrile illness at the time of entry into the study.
- Any treatment with immunosuppressive drugs, including oral and parenteral corticosteroids.
Inclusion and exclusion 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.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2007-28-12
Actual study completion date
2007-28-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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