Streptococcus pneumoniae are bacteria which normally live in the upper respiratory tract of humans. However, these bacteria can also cause severe infectious diseases such as pneumonia, septicemia and meningitis. Elderly subjects are especially vulnerable to these infections, and the diseases can result in death. The currently available licensed Streptococcus pneumoniae vaccine is recommended for prevention of pneumococcal diseases in individuals over the age of 65. However, the antibody level elicited by this vaccine, is not always satisfactory in elderly people. To overcome the problem, GlaxoSmithKline Biologicals is currently developing candidate vaccines that are hoped to work better than the currently available vaccines. As a first step in this development, the present study is being conducted in order to evaluate the immune response to the currently marketed vaccine.
Primary Outcome Measures:
- Response rate to 11 vaccine serotypes [ Time Frame: One month post vaccination ]
Secondary Outcome Measures:
- Occurrence of study related SAEs. [ Time Frame: Throughout the study period. ]
- Anti-polysaccharide total IgG ELISA for 11 vaccine pneumococcal serotypes [ Time Frame: At all time points ]
- Opsonophagocytic activity against 11 vaccine pneumococcal serotypes in a subset of subjects [ Time Frame: At Day 0 and Day 30. ]
- The rank of subjects from "poorest responder" to "best responder" based on the number of
serotypes each subject responds to [ Time Frame: One month post vaccination ]
- Persistence of the immune response in a subset of subjects. [ Time Frame: Until Month 36. ]
- Opsonophagocytic activity response in a subset of subjects. [ Time Frame: At Day 30 ]
- Occurrence of serious adverse events (SAE). [ Time Frame: Up to 1 month after vaccination. ]
Enrollment: |
1198 |
Study Start Date: |
October 2003 |
Primary Completion Date: |
March 2007 (Final data collection date for primary outcome measure) |
Group A: Experimental
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Biological: Pneumovax 23™
Single dose intramuscular injection
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Since influenza vaccination is recommended in the age range of the study population, Fluarix™ (GlaxoSmithKline Biologicals) vaccine will be offered free of charge for the study period (3 consecutive years), 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.