Evaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and Older

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: GSK Bio's influenza vaccine GSK2186877A; Biological: Fluarix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00760617

111737

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older.

This protocol posting deals with objectives & outcome measures of the extension phase at year 1. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00540592).

Enrollment: 526 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
• A male or female aged 18-41 years or ≥65 years at the time of the vaccination and who participated in the 110847 study and completed the 6 month follow-up.
• Written informed consent obtained from the subject.
• Fee of acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
• Female subjects must be of non-childbearing potential.

Exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
• Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
• Vaccination against influenza since January 2008 with a seasonal influenza vaccine.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of hypersensivity to a previous dose of influenza vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine(s).
• Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
• Any medical conditions in which IM injections are contraindicated.
• Lactating female, female planning to become pregnant or planning to discontinue contraceptive precautions.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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526 participants in 3 patient groups

New generation influenza vaccine GSK2186877A Group

Experimental group

Description:

Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A

Treatment:

Biological: GSK Bio's influenza vaccine GSK2186877A

Fluarix elderly Group

Active Comparator group

Description:

Subjects aged ≥65 years received 1 dose of Fluarix vaccine

Treatment:

Biological: Fluarix

Fluarix young Group

Active Comparator group

Description:

Subjects aged 18-40 years received 1 dose of Fluarix vaccine

Treatment:

Biological: Fluarix