As the licensed pneumococcal vaccine is not always satisfactory in elderly, new investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note: The study consists of the primary phase (106068): vaccination and follow-up and the extension (106072) of the primary phase: 1 year follow-up. This protocol posting details the procedures of both the primary \& extension phase.
No new subjects will be enrolled in the Extension Phase of the study. All outcome measures at Month 12 will only be evaluated in the subjects in the Belgian site. Upon request, volunteers will receive flu vaccination free of charge. 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
DOUBLE
Enrollment
335
Two-dose intramuscular injection. Each group receiving one of the 3 formulations
Single-dose intramuscular injection.
1 intramuscular injection.
GSK Investigational Site
Ghent, Belgium
GSK Investigational Site
Pirkkala, Finland
GSK Investigational Site
Uppsala, Sweden
Occurrence, intensity and relationship to vaccination 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 31-day follow up period after each vaccine dose.
Occurrence and relationship to vaccination of all serious adverse events (SAEs).
Time frame: Throughout the study period.
Post vaccination concentration IgG ≥5 µg/mL and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11
Time frame: 1 month after Dose 2 in Groups A, B, C and 1 month after Dose 1 for Group D
Post vaccination concentration and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11, in Groups A through D.
Time frame: One month after the first vaccine dose.
Haematological and biochemical levels within or outside the normal ranges in all groups.
Time frame: At Months 0, 1, 3, 4 and 12.
IgG antibody concentrations to vaccine pneumococcal serotypes in all groups.
Time frame: At Months 0, 1, 3, 4 and 12.
Opsonophagocytic activity titres (OPA) against pneumococcal serotypes in all groups.
Time frame: At Months 0, 1, 3, 4 and 12
Frequencies of IgG PS-specific plasma cells generated by in vitro cultivated memory B-cells for 4 serotypes in all groups, and for 11 serotypes in 10 subjects per group.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Two-dose intramuscular injection
Time frame: At Months 0, 1, 4 and 12.
Anti-protein D, anti-tetanus and anti-diphtheria toxoids IgG antibody concentrations in Groups A, B, C and E.
Time frame: At Months 0, 1, 3, 4 and 12.
Frequencies of IgG carrier protein-specific plasma cells generated by in vitro cultivated memory B-cells in a subset of subjects (all subjects minus PS B-cell memory subset) of the Groups A, B, C and E.
Time frame: At Months 0, 1, 4 and 12.
Freq. of CD4+&CD8+ T cells with antigen-specific IL-2 &/or INFy &/or TNFa &/or CD40L secretion/expression to carrier protein as determined by ICS, in a subset of subjects (all subjects minus PS B-cell memory subset) of the Groups A, B, C and E.
Time frame: At Months 0, 1, 4 and 12.