Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: Fluarix™; Biological: Influenza vaccine GSK2321138A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985790

113237

Details and patient eligibility

About

The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.

Enrollment: 599 patients

Sex: All

Ages: 18 to 47 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For all subjects:

• Subjects who the investigator believes that they and/or their Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject/from the LAR(s).

For unprimed subjects:

• A male or female child aged 18 to 47 months at the time of the first vaccination.
• Children who did not have influenza vaccine in a previous season.

For primed subjects from study NCT00764790:

• Children who received Fluarix™ in the 111751 study NCT00764790.

Exclusion criteria

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• History of hypersensitivity to any vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending 28 days after each dose of vaccine(s).
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
• Acute disease at the time of enrolment.
• History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• Receipt of another seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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599 participants in 2 patient groups

GSK2321138A Group

Experimental group

Description:

Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.

Treatment:

Biological: Influenza vaccine GSK2321138A

Fluarix Group

Active Comparator group

Description:

Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.

Treatment:

Biological: Fluarix™