Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 3

Conditions: Influenza

Treatments: Biological: GSK pandemic vaccine GSK2340272A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01014091

113810

Details and patient eligibility

About

The objective of this study is to evaluate the safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years.

Enrollment: 60 patients

Sex: All

Ages: 3 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• Children, male or female, aged between 3 and 9 years at the time of first study vaccination.
• Written informed consent obtained from the parent(s) or LAR(s) of the subject.
• Healthy children, as established by medical history and clinical examination when entering the study.

Exclusion criteria

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.

• Clinically or virologically confirmed influenza infection within six months preceding the study start.

• Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.

• Have received any seasonal flu vaccine since last year.

• Previous administration of any H1N1 A/California-like vaccine

• Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

• Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.

• History of hypersensitivity to vaccines.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.

• History of any neurological disorders or seizures.

• 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°C on rectal setting.
  • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.

• Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.

• Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.

• Child in Care.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 6 patient groups

GSK2340272A F1 Y3-5 GROUP

Experimental group

Description:

Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.

Treatment:

Biological: GSK pandemic vaccine GSK2340272A

GSK2340272A F1 Y6-9 GROUP

Experimental group

Description:

Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.

Treatment:

Biological: GSK pandemic vaccine GSK2340272A

GSK2340272A F2 Y3-5 GROUP

Experimental group

Description:

Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.

Treatment:

Biological: GSK pandemic vaccine GSK2340272A

GSK2340272A F2 Y6-9 GROUP

Experimental group

Description:

Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.

Treatment:

Biological: GSK pandemic vaccine GSK2340272A

GSK2340272A F3 Y3-5 GROUP

Experimental group

Description:

Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

Treatment:

Biological: GSK pandemic vaccine GSK2340272A

GSK2340272A F3 Y6-9 GROUP

Experimental group

Description:

Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

Treatment:

Biological: GSK pandemic vaccine GSK2340272A