Study to Evaluate an Influenza Vaccine Candidate

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: Fluarix™; Biological: Influenza Vaccine GSK1247446A - 4 different formulations

Study type: Interventional

Funder types: Industry

Identifiers

NCT00540228

110794

2007-003776-18 (EudraCT Number)

Details and patient eligibility

About

In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.

Full description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Enrollment: 1,006 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Only subjects who the investigator believes that they can and will comply with the requirements of the protocol .
• A male or female between, and including, 18 - 64 years of age at the time of vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must have a negative pregnancy test, practice adequate contraception for 30 days prior to vaccination, and continue such precautions for 2 months after completion of the vaccination series.

Exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose
• Administration of a vaccine not foreseen by the study protocol from 30 days before vaccination, up to 21 days after vaccination.
• History of hypersensitivity to a previous dose of influenza vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s)
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Confirmed influenza infection within a year preceding the study start.
• Administration of an influenza vaccine within a year preceding the study start.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• Pregnant or lactating female.
• Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
• Acute disease at the time of enrolment.
• History of chronic alcohol consumption and/or drug abuse.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
• History of administration of experimental/licensed vaccine containing squalene and/or tocopherol within the last 12 months.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,006 participants in 5 patient groups

GSK1247446A 1 Group

Experimental group

Description:

Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Influenza Vaccine GSK1247446A - 4 different formulations

GSK1247446A 2 Group

Experimental group

Description:

Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Influenza Vaccine GSK1247446A - 4 different formulations

GSK1247446A 3 Group

Experimental group

Description:

Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Influenza Vaccine GSK1247446A - 4 different formulations

GSK1247446A 4 Group

Experimental group

Description:

Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Influenza Vaccine GSK1247446A - 4 different formulations

Fluarix Group

Active Comparator group

Description:

Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Fluarix™