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

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: FluarixTM

• Registration Number: NCT00750360
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10-03
• Primary Completion: 2007-12-01
• Study Completion: 2007-12-28
• Study First Submitted: 2008-09-09
• Study First Submitted QC: 2008-09-09
• Study First Posted: 2008-09-10
• Results First Submitted: 2008-12-23
• Results First Submitted QC: 2009-04-08
• Results First Posted: 2009-06-02
• Status Verified: 2016-11
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 883

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primed, > 6 to < 72 Months	FluarixTM	Subjects aged \> 6 months to \< 72 months who previously received a vaccination against influenza (primed).
Primed, ≥ 72 to < 108 Months	FluarixTM	Subjects aged ≥ 72 months to \< 108 months who previously received a vaccination against influenza (primed).
Primed, ≥ 216 Months	FluarixTM	Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
Primed, ≥ 108 to < 216 Months	FluarixTM	Subjects aged ≥ 108 months to \< 216 months who previously received a vaccination against influenza (primed).
Unprimed, > 6 to < 72 Months	FluarixTM	Subjects aged \> 6 months to \< 72 months who were previously not vaccinated against influenza (unprimed).
Unprimed, ≥ 72 to < 108 Months	FluarixTM	Subjects aged ≥ 72 months to \< 108 months who were previously not vaccinated against influenza (unprimed).

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Severe Unsolicited Adverse Events	During the 21-day follow-up period (Day 0 to Day 20) after vaccination	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

Secondary Outcome Measures

Name	Time	Method
Number of Participant Reporting Unsolicited Adverse Events.	During the 21-day follow-up period (Day 0 to Day 20) after vaccination	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.
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.	During the 4-day follow up (Day 0 to 3) after vaccination.	Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.	During the 4-day follow up (Day 0 to 3) after vaccination.	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.
Number of Participants Reporting Serious Adverse Events (SAE).	Within 1 month following vaccination	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.