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Trial record 45 of 156 for:    Recruiting, Not yet recruiting, Available Studies | "Influenza, Human"

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

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ClinicalTrials.gov Identifier: NCT02663102
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is collect safety information on the use of Fluarix Tetra according to the approved PI, over a period of 6 years from children (over 3 years of age) and adults in Korea.

Condition or disease Intervention/treatment
Influenza Other: Data collection

Detailed Description:

Adults and previously vaccinated children aged ≥36 months, a single dose of Fluarix Tetra will be administered. To previously unvaccinated children aged 36 months to <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.


Study Design

Study Type : Observational
Estimated Enrollment : 720 participants
Observational Model: Other
Time Perspective: Prospective
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.
Actual Study Start Date : October 21, 2016
Estimated Primary Completion Date : June 10, 2020
Estimated Study Completion Date : June 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Fluarix Tetra Group
Subjects aged 3 years and above who will receive Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).
Other: Data collection
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.


Outcome Measures

Primary Outcome Measures :
  1. Occurrence of expected and unexpected adverse events (AEs) [ Time Frame: During the 21 days (Day 0 to Day 20) follow-up period after vaccination ]
  2. Occurrence of serious adverse events (SAEs) [ Time Frame: From the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects aged 3 years and above who were vaccinated with Fluarix Tetra or eligible to receive Fluarix Tetra in Korea according to the locally approved PI.
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663102


Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Korea, Republic of
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 03722
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02663102     History of Changes
Other Study ID Numbers: 204687
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by GlaxoSmithKline:
Safety
Post-marketing
Korea
Drug utilization study
Fluarix Tetra

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Tetracycline
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action