Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Fluzone; Biological: Fluarix™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00383123

104858

Details and patient eligibility

About

The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Enrollment: 3,327 patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female child age 6 months to < 18 years at the time of the vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
• Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
• Written informed consent obtained from the subject's parent/guardian; assent obtained in subjects > 10 years.
• Female subjects of childbearing potential must agree to take a pregnancy test.

Exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine, other than the study vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion.
• History of hypersensitivity to any vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrollment.
• History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• Pregnant or lactating female.
• Receipt of an influenza vaccine outside of this study, during current (2006-07) flu season.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,327 participants in 2 patient groups

Fluarix Group

Experimental group

Description:

Subjects in this group received Fluarix™ and will be further stratified by 3 age groups * 1:1 in 6 months to \< 36 months * 1:1 in 3 to \< 5 years * 3:1 in 5 to \< 18 years

Treatment:

Biological: Fluarix™

Fluzone Group

Active Comparator group

Description:

Subjects in this group received Fluzone and will be further stratified by 3 age groups * 1:1 in 6 months to \< 36 months * 1:1 in 3 to \< 5 years * 3:1 in 5 to \< 18 years

Treatment:

Biological: Fluzone