Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: GSK Biologicals' Fluarix™; Biological: Influenza vaccine GSK2186877A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00772889

111738

Details and patient eligibility

About

The purpose of this observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516).

Enrollment: 971 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female subject previously enrolled in study 109821 (NCT 00529516) in the >= 65 years and 18-41 years of age groups and having received the study vaccine.
• Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
• Written informed consent obtained from the subject.
• Free of an acute aggravation of the health status as established by medical history and clinical examination before entering into the study
• If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion criteria

• 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 a vaccine not foreseen by the study protocol up to 30 days after vaccination.
• Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
• Any vaccination against influenza since January 2008 with any seasonal influenza vaccine.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of hypersensitivity to a previous dose of influenza vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccines.
• Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by 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 administration of the study vaccine or planned administration during the study period.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period.
• Any medical conditions in which intramuscular injections are contraindicated.
• Pregnant or lactating females.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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971 participants in 3 patient groups

New generation influenza vaccine GSK2186877A Group

Experimental group

Description:

Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.

Treatment:

Biological: Influenza vaccine GSK2186877A

Fluarix elderly Group

Active Comparator group

Description:

Subjects aged ≥66 years received one dose of Fluarix vaccine.

Treatment:

Biological: GSK Biologicals' Fluarix™

Fluarix young Group

Active Comparator group

Description:

Subjects aged 19-43 years received one dose of Fluarix vaccine.

Treatment:

Biological: GSK Biologicals' Fluarix™