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

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 2

Conditions: Influenza Vaccines; Influenza

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01195779

114294

2010-020312-12 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 6 to 35 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4 participants in 14 patient groups

GSK2584786A vaccine 1 dose of Formulation A1 Group

Experimental group

Description:

Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.

Treatment:

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 2 doses of Formulation A1 Group

Experimental group

Description:

Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.

Treatment:

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 1 dose of Formulation A2 Group

Experimental group

Description:

Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.

Treatment:

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 2 doses of Formulation A2 Group

Experimental group

Description:

Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.

Treatment:

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 1 dose of Formulation A3 Group

Experimental group

Description:

Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.

Treatment:

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 2 doses of Formulation A3 Group

Experimental group

Description:

Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.

Treatment:

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 1 dose of Formulation B1 Group

Experimental group

Description:

Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.

Treatment:

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 2 doses of Formulation B1 Group

Experimental group

Description:

Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.

Treatment:

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 1 dose of Formulation B2 Group

Experimental group

Description:

Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.

Treatment:

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 2 doses of Formulation B2 Group

Experimental group

Description:

Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.

Treatment:

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 1 dose of Formulation B3 Group

Experimental group

Description:

Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.

Treatment:

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 2 doses of Formulation B3 Group

Experimental group

Description:

Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.

Treatment:

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2321138A vaccine Group

Experimental group

Description:

Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).

Treatment:

Biological: GSK Bio's influenza vaccine GSK2321138A

Fluarix Group

Active Comparator group

Description:

Subjects received 2 doses of Fluarix Vaccine.

Treatment:

Biological: Fluarix™