Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine, Fluarix/Influsplit Tetra® (2013/2014 Season), in Adults 18 Years of Age and Older

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Fluarix/Influsplit Tetra® (2013-2014 season)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01878812

200188

2013-001094-25 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess, in adults 18 years of age and above, the immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit Tetra containing the four influenza strains (two A strains and two B strains) for the 2013/2014 season.

Enrollment: 117 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.

  • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.

• 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

• Participation in previous year's Fluarix registration study (116663).

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.

• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.

• Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.

• 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 twelve months preceding the study vaccination.

• Receipt of a vaccine other than the study vaccine within 30 days before study vaccination and/or plan to receive any vaccine other than the study vaccine 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 enrollment.

  • Fever is defined as temperature ≥ 37.5°C/99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The preferred route for recording temperature in this study will be axillary.
  • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.

• Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

• Chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insulin-dependent diabetes mellitus), 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 (no laboratory testing required).

• History of Guillain-Barré syndrome.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including latex.

• 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 or would make intramuscular injection unsafe.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

117 participants in 2 patient groups

Fluarix/Influsplit Tetra® Adult Group

Experimental group

Description:

Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Fluarix/Influsplit Tetra® (2013-2014 season)

Fluarix/Influsplit Tetra® Elderly Group

Experimental group

Description:

Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Fluarix/Influsplit Tetra® (2013-2014 season)