Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Fluarix; Biological: Fluzone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00764790

111751

Details and patient eligibility

About

The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.

Enrollment: 3,317 patients

Sex: All

Ages: 6 to 35 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female child aged 6 to 35 months at the time of the first 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.
• Written informed consent obtained from the subject's parent/guardian.

Exclusion criteria

• Use of any investigational or non-registered product (drug or 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 criterion.
• 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 enrolment.
• History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.
• Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,317 participants in 3 patient groups

Fluarix Dose A Group

Experimental group

Description:

Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age). \* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Treatment:

Biological: Fluarix

Fluarix Dose B Group

Experimental group

Description:

Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age). \* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Treatment:

Biological: Fluarix

Fluzone Group

Active Comparator group

Description:

Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age). \* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Treatment:

Biological: Fluzone