Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine, Fluarix / Influsplit SSW (2013/2014 season), in adults 18 years of age and older.

• Conditions: Therapeutic area: Diseases [C] - Virus Diseases [C02]; Immunization of healthy adults against influenza; MedDRA version: 14.1Level: LLTClassification code 10059430Term: Influenza immunizationSystem Organ Class: 100000004865

• Registration Number: EUCTR2013-000855-42-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-26
• Last Update Posted: 18 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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 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 enrolment.
- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified