Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Influenza, Human

Treatments: Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT02663102

204687

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,388 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

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 design

1,388 participants in 2 patient groups

Fluarix Tetra Group 1

Description:

Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).

Treatment:

Other: Data collection

Fluarix Tetra Group 2

Description:

Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).

Treatment:

Other: Data collection