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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Biological: Fluarix; Biological: Influenza vaccine GSK2186877A formulation 1; Biological: Influenza vaccine GSK2186877A formulation 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01096056

114182

Details and patient eligibility

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: 40 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.

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Influenza vaccine GSK2186877A formulation 1 Group

Experimental group

Description:

Subjects received 2 doses of influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.

Treatment:

Biological: Fluarix

Biological: Influenza vaccine GSK2186877A formulation 1

Influenza vaccine GSK2186877A formulation 2 Group

Experimental group

Description:

Subjects received 1 dose of influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.

Treatment:

Biological: Fluarix

Biological: Influenza vaccine GSK2186877A formulation 2