Study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ quadrivalent influenza candidate vaccine GSK2321138A (FLU D-QIV), when administered to children 18 to 47 months of age.

• Conditions: Healthy volunteers (immunisation against influenza in male and female subjects 18 to 47 months of age inclusive).; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-002587-27-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-11
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Subject’s parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• A male or female child between, and including, 18 and 47 months of age at the time of the first vaccination.
• Written informed consent obtained from the par-ent(s)/LAR(s) of the subject.
• Children who had not received 2 doses of influenza vaccine in a previous season.
• In addition, primed subjects from the 111751 study (FluarixUS-007) willing to participate in this study had to satisfy the following criterion at study entry:
• Children who had received 2 doses of Fluarix (0.5 mL) in the 111751 study (FluarixUS-007).

Are the trial subjects under 18? yes
Number of subjects for this age range: 599
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
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 first dose of study vaccine, or planned use during the study period.
• History of hypersensitivity to any vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine (including egg, chicken protein, formaldehyde, gentamicin sulfate or sodium de-oxycholate).
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending 28 days after each dose of vaccine(s).
• Acute or chronic clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as de-termined by medical history and physical examination.
• Acute disease at the time of enrolment. (Acute disease was defined as the presence of a moderate or severe ill-ness with or without fever. All vaccines could be adminis-tered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/axillary temperature <37.5°C (99.5°F) or rectal temperature <38.0°C (100.4°F).
• History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• Receipt of another seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
• Any confirmed or suspected immunosuppressive or im-munodeficient condition based on medical history and physical examination (no laboratory testing required).
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination (for corti-costeroids, this meant prednisone greater than or equal to 10 milligram/day (10 mg/day), or equivalent). Inhaled and topical steroids were allowed.
• Administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vac-cine or planned administration during the study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject had been or would be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Study & Design

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