Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Biological: GSK Biologicals' trivalent influenza vaccine; Biological: GSK Biologicals' quadrivalent influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00714285

111295

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.

Enrollment: 420 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 18 and 60 years of age at the time of the vaccination.
• Written informed consent obtained from the subject.
• If the subject is female, she must be of non-childbearing potential, if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test 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 administration 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 3 months prior to administration of the vaccine.
• Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination.
• Confirmed influenza infection within a year preceding the study start.
• Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.
• Concurrently participating 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 (pharmaceutical product or device).
• 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 disease 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.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• 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.
• History of administration of experimental/licensed vaccine.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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420 participants in 4 patient groups

Quadrivalent influenza vaccine GSK 2115160A Group 1

Experimental group

Description:

Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0

Treatment:

Biological: GSK Biologicals' quadrivalent influenza vaccine

Quadrivalent influenza vaccine GSK 2115160A Group 2

Experimental group

Description:

Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0

Treatment:

Biological: GSK Biologicals' quadrivalent influenza vaccine

Trivalent influenza vaccine GSK 2115160A Group 1

Active Comparator group

Description:

Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0

Treatment:

Biological: GSK Biologicals' trivalent influenza vaccine

Trivalent influenza vaccine GSK 2115160A Group 2

Active Comparator group

Description:

Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0

Treatment:

Biological: GSK Biologicals' trivalent influenza vaccine