Trial to Evaluate the Safety and the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Healthy Children

GlaxoSmithKline40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Influenza

Interventions

Influenza vaccine GSK2186877A formulation 1BIOLOGICAL

Intramuscular administration, 2 doses

Influenza vaccine GSK2186877A formulation 2BIOLOGICAL

Intramuscular administration, 1 dose

FluarixBIOLOGICAL

Intramuscular administration, 1 dose

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 35 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: * Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol. * Children, 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. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Age appropriate scheduled childhood vaccinations completed to the best of parent(s)/LAR(s) knowledge. 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: * Fever is defined as temperature \>= 37.5°C on oral, axillary or tympanic setting, or \>=38.0°C on rectal setting. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever might be enrolled at the discretion of the investigator. * 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.

Locations (1)

GSK Investigational Site

Seville, Spain

Outcomes

Primary Outcomes

Number of Subjects Reporting Fever Grade 2 or Higher

Fever grade greater than or equal to 2 i.e. ≥ 2 was defined as axillary temperature \>38 degree centigrade (°C).

Time frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A

Secondary Outcomes

Haemagglutination Inhibition (HI) Antibody Titers

Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.

Time frame: At Day 0 and Day 42

The Number of Subjects Seropositive to HI Antibodies

A seropositive subject was defined as a subject with antibody titer greater than or equal to 1:10. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.

Time frame: At Day 0 and Day 42

The Number of Subjects Seroprotected to HI Antibodies

A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.

Time frame: At Day 0 and Day 42

The Number of Subjects Seroconverted to HI Antibodies

A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.

Time frame: Day 42

Data from ClinicalTrials.gov

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