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About
The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in healthy children 6 to 35 months of age.
This Protocol Posting has been updated following Amendment 1 of the Protocol, Jun 2010. The impacted sections are study design, outcome measures, intervention sections and number of subjects.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
All subjects must satisfy ALL the following criteria at study entry:
Exclusion criteria
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
Child in care
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Prior receipt of any influenza vaccination (seasonal or pandemic) or planned administration during the study period.
Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
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 >0.5 mg/kg of body weight, or equivalent. Inhaled and topical steroids are allowed.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
A family history of congenital or hereditary immunodeficiency.
Any known or suspected allergy to any constituent of influenza or routine paediatric vaccines, a history of severe adverse reaction to any previous vaccination; or a history of anaphylactic-type reaction to consumption of egg proteins.
History of any neurological disorders or seizures (including febrile convulsion).
Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination.
Acute disease and/or fever at the time of enrolment:
Administration of immunoglobulins and/or any blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
Any condition which, in the opinion of the investigator, render the subject unfit for participation in the study.
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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