A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Fluarix/Influsplit SSW 2012-2013

Study type: Interventional

Funder types: Industry

Identifiers

NCT01607112

116663

2012-000789-39 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in adults (18 to 60 years) and in elderly (over 60 years).

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol.

• A male or female aged 18 years or above at the time of vaccination.

• Written informed consent obtained from the subject.

• Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering 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 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 vaccination.

Exclusion criteria

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
• Administration of an influenza vaccine within the six months preceding the study vaccination.
• Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and during the entire study period.
• Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
• Acute disease and/or fever at the time of enrolment.
• Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Chronic underlying disease, not stabilized or clinically serious.
• History of chronic alcohol consumption and/or drug abuse.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of Guillain-Barré syndrome.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Anaphylaxis following the administration of vaccine(s).
• Pregnant or lactating female.
• 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

Fluarix/Influsplit 18-60 Years Group

Experimental group

Description:

Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

Treatment:

Biological: Fluarix/Influsplit SSW 2012-2013

Fluarix/Influsplit > 60 Years Group

Experimental group

Description:

Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

Treatment:

Biological: Fluarix/Influsplit SSW 2012-2013