Study to evaluate immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ quadrivalent influenza vaccine GSK2282512A when administered to children 6 to 35 months of age

• Conditions: Healthy volunteers (Immunisation against influenza in male and female subjects 6 to 35 months of age inclusive); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-003155-38-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-27
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 601

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 between, and including, 6 and 35 months of age at the time of the first vaccination.
•Written informed consent obtained from the parent(s)/LAR(s) of the subject.
•Subjects in stable health as determined by the investigator’s clinical examination and assessment of subject’s medical history.
•Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.

Are the trial subjects under 18? yes
Number of subjects for this age range: 601
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 other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted.
•Child in care
•Prior receipt of any seasonal or pandemic influenza vaccine within six months preceding the first dose of study vaccine, or planned use during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dosed.
•Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
•History of Guillain-Barré syndrome within six weeks of receipt of prior influenza vaccine.
•Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
•Acute disease and/or fever at the time of enrolment.
•Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•Any other condition which, in the opinion of the investiga-tor, prevents the subject from participating in the study.

Study & Design

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