N/A
Completed N=1,388
Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.
Influenza, Human
Source: ClinicalTrials.gov NCT02663102 ↗
Enrolled (actual)
1,388
Serious AEs
0.3%
Results posted
Apr 2024
Primary outcomePrimary: Number of Participants With Expected Adverse Events (AEs) — 54; 44 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Expected Adverse Events (AEs) |
54; 44 | — |
| PRIMARY Number of Participants With Unexpected Adverse Events (AEs) |
116; 62 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
3; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02663102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.