Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Prophylaxis Invasive Pneumococcal Diseases and Pneumonia

Treatments: Biological: Pneumovax 23™; Biological: Pneumococcal vaccine GSK513026

Study type: Interventional

Funder types: Industry

Identifiers

NCT00307528

100463 (Other Identifier)

100409

100464 (Other Identifier)

Details and patient eligibility

About

As the licensed Pneumovax 23™ vaccine is not always satisfactory in elderly subjects, the safety and the immune response of the new investigational pneumococcal protein vaccine is evaluated in healthy elderly population.

Full description

Since influenza vaccination is recommended in the age range of the study population, Fluarix™ (GlaxoSmithKline Biologicals) vaccine will be offered free of charge during the study period (for 3 consecutive years starting from September 2004), to be used by Investigators according to national vaccination schedule/practice.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Enrollment: 146 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Subjects who the investigator believes will comply with the requirements of the protocol
• A male or female ≥ 65 years at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Use of any anticoagulants.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccines.
• Previous vaccination against Streptococcus pneumoniae.
• Bacterial pneumonia within 3 years prior to 1st vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Current serious neurologic or mental disorders.
• Currently smoking > 25 cigarettes per day.
• Inflammatory processes such as known chronic active infections
• All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
• History of administration of an experimental vaccine containing MPL or QS21.
• Acute disease at the time of enrolment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator.
• History of chronic alcohol consumption and/or intravenous drug abuse.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 6 patient groups

Group A

Active Comparator group

Treatment:

Biological: Pneumovax 23™

Group B

Experimental group

Treatment:

Biological: Pneumococcal vaccine GSK513026

Group C

Experimental group

Treatment:

Biological: Pneumococcal vaccine GSK513026

Group D

Experimental group

Treatment:

Biological: Pneumococcal vaccine GSK513026

Group E

Experimental group

Treatment:

Biological: Pneumococcal vaccine GSK513026

Group F

Experimental group

Treatment:

Biological: Pneumococcal vaccine GSK513026