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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00750360

Purpose

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).

Condition	Intervention	Phase
Seasonal Influenza	Biological: FluarixTM	Phase IV

MedlinePlus related topics: Flu

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	Study to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Influenza Split Vaccine FLUARIX™ Administered According to the Prescribing Information in Korean Subjects Aged > 6 Months of Age at the Time of Vaccination.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of severe unsolicited adverse events [ Time Frame: During the 21-day follow-up period (Day 0 to Day 20) after vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Occurrence of solicited local and general adverse events [ Time Frame: During the 4-day follow up (Day 0 to 3) after vaccination. ] [ Designated as safety issue: Yes ]
Occurrence of unsolicited adverse events. [ Time Frame: During the 21-day follow-up period (Day 0 to Day 20) after vaccination ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events. [ Time Frame: During the entire study period ] [ Designated as safety issue: Yes ]

Enrollment:	883
Study Start Date:	October 2003
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group B: Experimental Subjects aged < 9 years who were previously not vaccinated against influenza	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).
Group A: Experimental Subjects aged ≥ 9 years and subjects 6 months to 9 years who have previously been vaccinated against influenza	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).

Eligibility

Ages Eligible for Study:	6 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750360

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	218352/054
Study First Received:	September 9, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00750360 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by GlaxoSmithKline:

Influenza
FluarixTM
Korea

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009