Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations; Biological: Fluarix TM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00321763

107214 (Other Identifier)

107192

Details and patient eligibility

About

The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

Full description

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

Enrollment: 3,124 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female age 60 years or older at the time of the vaccination.
• Subjects who the investigator believes can and will comply with the requirements of the protocol
• Written informed consent obtained from the subject.
• Free of an acute aggravation of the health status as established by clinical examination before entering into the study.

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.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
• Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
• History of hypersensitivity to a previous dose of influenza vaccine.
• History of confirmed influenza infection within the last 12 months.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
• Acute disease at the time of enrolment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,124 participants in 5 patient groups

GSK1247446A Lot 1 Group

Experimental group

Description:

Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Treatment:

Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations

GSK1247446A Lot 2 Group

Experimental group

Description:

Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Treatment:

Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations

GSK1247446A Lot 3 Group

Experimental group

Description:

Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Treatment:

Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations

GSK1247446A Pooled Group

Experimental group

Description:

Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.

Treatment:

Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations

Fluarix Group

Active Comparator group

Description:

Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.

Treatment:

Biological: Fluarix TM