Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: FluarixTM; Biological: Influenza vaccine GSK2604409A; Biological: Influenza vaccine GSK2321138A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01204671

114269

Details and patient eligibility

About

This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.

Enrollment: 4,659 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female 18 years of age or older at the time of the first vaccination
• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject.
• Healthy subjects or those with chronic well-controlled disease as established by physical examination before entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• • has practiced adequate contraception for 30 days prior to vaccination,
• • and has a negative urine pregnancy test on the day of vaccination,
• and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Exclusion criteria

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of the study vaccine or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
• Administration of an influenza vaccine during the 6 months preceding entry into the study.
• Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to Day 21.
• Any contra-indication to intramuscular administration of the influenza vaccines.
• History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• Any administration of a long-acting immune-modifying drug within 3 months before study start, or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Acute disease and/or fever at the time of enrolment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
• History of chronic alcohol consumption and/or drug abuse.
• Any condition which, in the opinion of the investigator, prevents the subject from participating in the study
• Pregnant or lactating female.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,659 participants in 5 patient groups

GSK2321138A Lot 1 Group

Experimental group

Description:

Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Influenza vaccine GSK2321138A

GSK2321138A Lot 2 Group

Experimental group

Description:

Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Influenza vaccine GSK2321138A

GSK2321138A Lot 3 Group

Experimental group

Description:

Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Influenza vaccine GSK2321138A

Fluarix Group

Active Comparator group

Description:

Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: FluarixTM

GSK2604409A Group

Active Comparator group

Description:

Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Influenza vaccine GSK2604409A