Clinical trial NCT02663102: Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza, Human
Keywords: Safety
Post-marketing
Korea
Drug utilization study
Fluarix Tetra
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-01-26
Enrollment: 1388
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects aged 6 months and above who were vaccinated with Fluarix Tetra or eligible to receive Fluarix Tetra in Korea according to the locally approved PI.

Brief summary: 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.

Detailed description: Adults and previously vaccinated children aged ≥6 months, a single dose of Fluarix Tetra will be administered. To previously unvaccinated children aged 6 months to less than (\<) 9 years, two doses will be administered with a second dose at least 4 weeks apart from the first one as per the local PI in Korea.

Fluarix Tetra may be administered to pregnant women/lactating women as per PI, if there is a clear need. Pregnancy outcome (whether full-term or premature, information on the status of the mother and child) in vaccinated pregnant subjects will be followed-up at 6-8 weeks after delivery, if possible.

Eligibility 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.

Primary outcomes:
measure: 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)
measure: 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)
measure: 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:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Donghae
country: Korea, Republic of
facility: GSK Investigational Site
city: Gwangmyeong
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeongsangbuk-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Ulsan
country: Korea, Republic of
facility: GSK Investigational Site
city: Yangju-si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: