Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Influenza

Treatments

Biological: Fluzone®

Biological: FluLaval® Quadrivalent

Study type

Interventional

Funder types

Industry

Identifiers

NCT01974895

200806

Details and patient eligibility

About

The purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.

Full description

The subjects will be randomised (1:1) in the two treatment groups (Q-QIV and TIV-YB) to explore response to vaccination.

Enrollment

316 patients

Sex

All

Ages

6 to 35 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects' 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 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.

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.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
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.
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 enrollment.
- Fever is defined as temperature ≥ 38.0°C/100.4°F by any method.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
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 investigator, prevents the subject from participating in the study.