A phase III randomized, partially-blind, controlled, multi-country, multi-centre study to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals’ quadrivalent influenza vaccine D-QIV (GSK2321138A) and to evaluate the clinical consistency of three production lots of D-QIV in terms of immunogenicity, when administered intramuscularly to adults 18 years of age and older. - FLU D-QIV-008

• Conditions: Immunisation of adults 18 years of age and older against influenza infection.; MedDRA version: 12.1Level: LLTClassification code 10022000Term: Influenza

• Registration Number: EUCTR2010-021034-63-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-21
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4600

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 (e.g. completion of the diary cards, return for follow-up visits).
•Written informed consent obtained from the subject before any study procedure.
•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 .
?Non-childbearing potential is defined as 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 the vaccination series

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines 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 six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
•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 Visit 2.
•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 including latex.
•Any administration of a long-acting immune-modifying drug (e.g. rituximab, infliximab) 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 (no laboratory testing required).
•Acute disease and/or fever at the time of enrolment.
?Fever is defined as temperature = 37.5°C (99.5°F) on oral or axillary 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 or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
•History of Guillain-Barre syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine
•Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
•Pregnant or lactating female.
•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.

Study & Design

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