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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: FluarixTM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00750360

218352/054

Details and patient eligibility

About

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).

Enrollment: 883 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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883 participants in 6 patient groups

Unprimed, > 6 to < 72 Months

Experimental group

Description:

Subjects aged \> 6 months to \< 72 months who were previously not vaccinated against influenza (unprimed).

Treatment:

Biological: FluarixTM

Unprimed, ≥ 72 to < 108 Months

Experimental group

Description:

Subjects aged ≥ 72 months to \< 108 months who were previously not vaccinated against influenza (unprimed).

Treatment:

Biological: FluarixTM

Primed, > 6 to < 72 Months

Experimental group

Description:

Subjects aged \> 6 months to \< 72 months who previously received a vaccination against influenza (primed).

Treatment:

Biological: FluarixTM

Primed, ≥ 72 to < 108 Months

Experimental group

Description:

Subjects aged ≥ 72 months to \< 108 months who previously received a vaccination against influenza (primed).

Treatment:

Biological: FluarixTM

Primed, ≥ 108 to < 216 Months

Experimental group

Description:

Subjects aged ≥ 108 months to \< 216 months who previously received a vaccination against influenza (primed).

Treatment:

Biological: FluarixTM

Primed, ≥ 216 Months

Experimental group

Description:

Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).

Treatment:

Biological: FluarixTM