Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children

Phase 2

Terminated

Conditions: Influenza Vaccines
Influenza

Interventions: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Biological: GSK Bio's influenza vaccine GSK2321138A
Biological: Fluarix™

Registration Number: NCT01195779

Lead Sponsor: GlaxoSmithKline

Brief Summary: The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months of age.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 4

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.
Born after gestation period of 36 to 42 weeks inclusive

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 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 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 of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
A family history of congenital or hereditary immunodeficiency.
A family history of febrile seizures or/and epilepsy
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 any constituent of influenza vaccine.
History of any progressive neurological disorders or seizures.
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 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSK2584786A vaccine 1 dose of Formulation A1 Group	GSK Bio's influenza vaccine GSK2584786A, different formulations	Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
GSK2584786A vaccine 2 doses of Formulation B2 Group	GSK Bio's influenza vaccine GSK2584786A, different formulations	Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
GSK2584786A vaccine 1 dose of Formulation B3 Group	GSK Bio's influenza vaccine GSK2584786A, different formulations	Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
GSK2584786A vaccine 2 doses of Formulation B3 Group	GSK Bio's influenza vaccine GSK2584786A, different formulations	Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
GSK2321138A vaccine Group	GSK Bio's influenza vaccine GSK2321138A	Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
GSK2584786A vaccine 2 doses of Formulation A1 Group	GSK Bio's influenza vaccine GSK2584786A, different formulations	Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
GSK2584786A vaccine 2 doses of Formulation A2 Group	GSK Bio's influenza vaccine GSK2584786A, different formulations	Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
GSK2584786A vaccine 1 dose of Formulation A3 Group	GSK Bio's influenza vaccine GSK2584786A, different formulations	Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
GSK2584786A vaccine 1 dose of Formulation B1 Group	GSK Bio's influenza vaccine GSK2584786A, different formulations	Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
GSK2584786A vaccine 1 dose of Formulation A2 Group	GSK Bio's influenza vaccine GSK2584786A, different formulations	Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
GSK2584786A vaccine 2 doses of Formulation A3 Group	GSK Bio's influenza vaccine GSK2584786A, different formulations	Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
GSK2584786A vaccine 1 dose of Formulation B2 Group	GSK Bio's influenza vaccine GSK2584786A, different formulations	Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
Fluarix Group	Fluarix™	Subjects received 2 doses of Fluarix Vaccine.
GSK2584786A vaccine 2 doses of Formulation B1 Group	GSK Bio's influenza vaccine GSK2584786A, different formulations	Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.

Primary Outcome Measures

Name	Time	Method
Serum Neutralizing Antibody Titers	at Day 28/ Day 56
Geometric Mean Number of All-CD4 Cytokine Positive Cells	at Day 28/ Day 56	Geometric mean of the number of CD4 cytokine positive T cells per million T cells.
Number of Subjects Reporting Fever of at Least Grade 2 or Higher	Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine	Grade 2 fever was defined as axillary temperature above 38 degrees Celcius.
Serum Haemagglutination-inhibition (HI) Antibody Titers	at Day 28/ Day 56	Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Potential Immune-mediated Diseases	From Day 0 to 179	Potential Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	within 28 days (Day 0 to Day 27) after any vaccination	Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects Reporting Adverse Events With Medically Attended Visits	From Day 0 to 179	A mediaclly attended visit is defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
Number of Subjects Reporting Serious Adverse Events	From Day 0 to 179	SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Serum HI Antibody Titers	on Days 0, 28/56 and 180	Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.
Serum Neutralising Antibody Titers	on Days 0, 28/56 and 180	Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.
Number of Subjects Reporting Solicited Local and General Symptoms	during a 7 day follow-up period (Day 0 to 6) after any vaccination	Solicited local symptoms included pain, redness and swelling at the injection site. Solicited general symptoms included drowsiness, fever, irritability and loss of appetite.