Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.

Study to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Influenza Split Vaccine FLUARIX™ Administered According to the Prescribing Information in Korean Subjects Aged More Than 6 Months of Age at the Time of Vaccination

The present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of Korean Food and Drugs Administration (KFDA).

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: FluarixTM

• Study Type: Interventional
• Enrollment (Actual): 883
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A male or female > 6 months of age at the time of the first vaccination.
• Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• Free of obvious health problems as established by medical history and clinical examination judged by the investigator before entering into the study.
• If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.

Exclusion Criteria:

• Clinical signs of acute febrile illness at the time of entry into the study.
• Any treatment with immunosuppressive drugs, including oral and parenteral corticosteroids.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or previous severe reaction to influenza virus vaccine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unprimed, > 6 to < 72 Months; Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).	Biological: FluarixTM; All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).
Experimental: Unprimed, ≥ 72 to < 108 Months; Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).	Biological: FluarixTM; All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).
Experimental: Primed, > 6 to < 72 Months; Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).	Biological: FluarixTM; All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).
Experimental: Primed, ≥ 72 to < 108 Months; Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).	Biological: FluarixTM; All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).
Experimental: Primed, ≥ 108 to < 216 Months; Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).	Biological: FluarixTM; All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).
Experimental: Primed, ≥ 216 Months; Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).	Biological: FluarixTM; All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Severe Unsolicited Adverse Events	An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities	During the 21-day follow-up period (Day 0 to Day 20) after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.	Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.	During the 4-day follow up (Day 0 to 3) after vaccination.
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.	Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis.	During the 4-day follow up (Day 0 to 3) after vaccination.
Number of Participant Reporting Unsolicited Adverse Events.	An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.	During the 21-day follow-up period (Day 0 to Day 20) after vaccination
Number of Participants Reporting Serious Adverse Events (SAE).	An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.	Within 1 month following vaccination

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: October 3, 2003
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 28, 2007

Study Registration Dates

• First Submitted: September 9, 2008
• First Submitted That Met QC Criteria: September 9, 2008
• First Posted (Estimate): September 10, 2008

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Influenza; Korea; FluarixTM
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 218352/054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Statistical Analysis Plan
   Information identifier: 218352/054
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 218352/054
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Informed Consent Form
   Information identifier: 218352/054
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 218352/054
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 218352/054
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Individual Participant Data Set
   Information identifier: 218352/054
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register