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

NCT02663102 | Completed Results

• 1 other identifier: 204687
• Study Type: observational
• Target: 1,388
• Locations: 1 country
• Sites: 21

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.

Conditions

Influenza, Human

Keywords

Safety; Post-marketing; Korea; Drug utilization study; Fluarix Tetra

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Expected Adverse Events (AEs)

  An adverse event that is expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information.

  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)

  Any adverse event reported in addition to those expected during the drug use investigation. Adverse events that are not reflected in the approved Prescribing Information.

  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)

  SAEs assessed included any adverse event that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject.

  During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)

Study Arms (2)

Fluarix Tetra Group 1

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).

Other: Data collection

Fluarix Tetra Group 2

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

Other: Data collection

Interventions

Data collection OTHER

Safety monitoring and evaluation: - Recording of all AEs during the study period using diary cards, follow-up contact via telephone or email. - Recording of SAEs throughout the study period for each subject.

Fluarix Tetra Group 1; Fluarix Tetra Group 2

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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) \[LAR(s)\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (21)

GSK Investigational Site

Busan, 47545, South Korea

Location

GSK Investigational Site

Daegu, 42274, South Korea

Location

GSK Investigational Site

Daegu, 42601, South Korea

Location

GSK Investigational Site

Daegu, 700 712, South Korea

Location

GSK Investigational Site

Donghae, 25768, South Korea

Location

GSK Investigational Site

Gwangmyeong, 484 5, South Korea

Location

GSK Investigational Site

Gyeongsangbuk-do, 39230, South Korea

Location

GSK Investigational Site

Incheon, 22214, South Korea

Location

GSK Investigational Site

Seoul, 03181, South Korea

Location

GSK Investigational Site

Seoul, 03722, South Korea

Location

GSK Investigational Site

Seoul, 03966, South Korea

Location

GSK Investigational Site

Seoul, 04143, South Korea

Location

GSK Investigational Site

Seoul, 04168, South Korea

Location

GSK Investigational Site

Seoul, 06568, South Korea

Location

GSK Investigational Site

Seoul, 08737, South Korea

Location

GSK Investigational Site

Seoul, 135-720, South Korea

Location

GSK Investigational Site

Seoul, 138201, South Korea

Location

GSK Investigational Site

Seoul, 7499, South Korea

Location

GSK Investigational Site

Suwon-si, Gyeonggi-do, 16388, South Korea

Location

GSK Investigational Site

Ulsan, 683380, South Korea

Location

GSK Investigational Site

Yangju-si, Gyeonggi-do, 11456, South Korea

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: January 26, 2016
• Study Start: October 20, 2016
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: April 5, 2024
• Results First Posted: April 5, 2024

Record last verified: 2023-10

Locations

KR (21)