Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Fluarix Quadrivalent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01702454

2012-001230-34 (EudraCT Number)

116023

Details and patient eligibility

About

The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals' investigational vaccine GSK2321138A in children who previously participated in study 115345 (FLU D-QIV-004 PRI) (NCT01439360).

Enrollment: 470 patients

Sex: All

Ages: 17 to 48 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that parent(s)/LAR(s) can and will comply with the requirements of the protocol.
• Children, male or female who received a 2-dose vaccination in the study 115345 (NCT01439360).
• Written informed consent obtained from the parent(s)/LAR(s) of the subject.
• Subjects in stable health as determined by medical history and clinical examination before entering into the study.

Exclusion criteria

• Child in care.

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

• Since the start of study 115345 (NCT01439360), receipt of any seasonal influenza vaccine other than the study vaccines of study 115345 or planned administration of any influenza vaccine other than the study vaccine during the study.

• Administration of any vaccine not foreseen by the study protocol within 4 weeks preceding the first dose of study vaccine or planned use until Visit 2.

• Laboratory confirmed influenza infection outside of the 115345 (NCT01439360) study.

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

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to enrolment in the study or planned administration during the study period. Inhaled and topical steroids are allowed.

• Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.

• Any contraindication to intramuscular injection.

• Acute disease and/or fever at the time of enrollment:

  • Fever is defined as temperature ≥ 37.5°C by any route.
  • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.

• Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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470 participants in 2 patient groups

Fluarix Quadrivalent Primed Group

Experimental group

Description:

Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.

Treatment:

Biological: Fluarix Quadrivalent

Fluarix Quadrivalent Unprimed Group

Experimental group

Description:

Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.

Treatment:

Biological: Fluarix Quadrivalent