A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Fluarix™ VB; Biological: Fluarix™ YB; Biological: Quadrivalent seasonal influenza vaccine GSK2282512A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01198756

113314

Details and patient eligibility

About

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.

Enrollment: 3,109 patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.

• A male or female child aged between 6 months and 17 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season.

• Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.

• Written informed assent obtained from the subject if/as required by local regulations.

• Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.

• Female subjects of non-childbearing potential may be enrolled in the study.

• Female subjects of childbearing potential may be enrolled in the study, if the subject

  • Has practiced adequate contraception for 30 days prior to vaccination, and
  • Has a negative pregnancy urine test on the day of vaccination, and
  • Has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion criteria

• Child in care
• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
• History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine.
• Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
• Fever at the time of enrolment.
• Acute disease at the time of enrolment.
• Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Ongoing aspirin therapy.
• Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,109 participants in 4 patient groups

GSK2282512A 1 Group

Experimental group

Description:

Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Quadrivalent seasonal influenza vaccine GSK2282512A

Biological: Quadrivalent seasonal influenza vaccine GSK2282512A

Victoria strain Fluarix Group

Active Comparator group

Description:

Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Fluarix™ VB

Yamagata strain Fluarix Group

Active Comparator group

Description:

Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Fluarix™ YB

GSK2282512A 2 Group

Experimental group

Description:

Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.

Treatment:

Biological: Quadrivalent seasonal influenza vaccine GSK2282512A

Biological: Quadrivalent seasonal influenza vaccine GSK2282512A