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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
146
Two-dose intramuscular injection. Five different formulations, each administered to one Group
Single dose intramuscular injection.
GSK Investigational Site
Ghent, Belgium
Occurrence, intensity and relationship of any solicited local and general signs and symptoms.
Time frame: During a 7-day follow up period after each vaccine dose.
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms.
Time frame: During a 30-day follow up period after each vaccine dose.
Occurrence of all serious adverse events (SAE).
Time frame: During the entire study period.
Anti- PhtD antibody concentration
Time frame: One month after the first injection
Anti-PhtD antibody concentration.
Time frame: One month after 2 injections
Number and percentage of subjects with normal or abnormal values for biochemical assessments and for haematological analysis.
Time frame: At each scheduled time point (month 0, 1, 3, 12, 24 and 36).
Anti- PhtD antibody concentration.
Time frame: At 12, 24 and 36 months after the first vaccination.
Anti-PhtD antibody avidity.
Time frame: At month 0, 1 and 3.
Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals.
Time frame: At month 0, 1 and 3.
Frequency of PhtD specific plasma cells generated by in vitro cultivated memory B-cells, in a subset of subjects.
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Time frame: At month 0, 1, 3, 12.
Frequency of CD4 and/or CD8 T cells that produce cytokines (IL-2, IL-4, IFNg, CD40L and/or GM-CSF, and TNFα), upon PhtD re-stimulation in vitro, to evaluate the T-cell response, in a subset of subjects.
Time frame: At month 0, 1, 3, 12.
Anti-polysaccharide total IgG concentration in Group A for all vaccine pneumococcal serotypes
Time frame: At month 0, 1, 12, 24 and 36.
Anti-PS antibody avidity for 5 serotypes in Group A.
Time frame: At month 0 and 1.
Deposition of complement components on the surface of different bacterial strains 3 strains (GSK/CDC, OPA, isogenic TIGR4) of 5 serotypes in Group A.
Time frame: At month 0 and 1.
Opsonophagocytic activity titres in Group A to all vaccine pneumococcal serotypes
Time frame: At month 0, 1 and 12.
Frequency of PS-specific plasma cells generated by in vitro cultivated memory B-cells in Group A in a subset of subjects.
Time frame: At month 0 and month 1.