Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: Fluarix™; Biological: GSK1247446A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00374842

108656

Details and patient eligibility

About

The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years

Enrollment: 300 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female aged 18-59 years at the time of the first vaccination.
• Free of obvious health problems

Exclusion criteria

• Use of non-registered products
• Administration of immune-modifying drugs.
• Administration of vaccine 30 days before enrolment in study.
• Immunosuppressive or immunodeficient condition.
• Hypersensitivity to a previous dose of influenza vaccine
• Previous vaccination against influenza in 2006
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
• History of confirmed influenza infection within the last 12 Months.
• Acute disease at the time of enrolment/vaccination.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 3 patient groups

GSK1247446A Formulation 1 Group

Experimental group

Description:

Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: GSK1247446A

GSK1247446A Formulation 2 Group

Experimental group

Description:

Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: GSK1247446A

Fluarix Group

Active Comparator group

Description:

Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Fluarix™