Booster and immune memory study
Total: All 689 subjects enrolled in study 103488. 23PS group: Aventis Pasteurs' 23-valent polysaccharide pneumococcal vaccine (Pneumovax 23) + DTPa-HBV-IPV/Hib; 10V group: GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
689
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, Germany
GSK Investigational Site
Bretten, Baden-Wurttemberg, Germany
GSK Investigational Site
Eppelheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Kehl, Baden-Wurttemberg, Germany
GSK Investigational Site
Oberkirch, Baden-Wurttemberg, Germany
1 mth after admin. of booster dose with either GSK Biologicals' 10Pn-PD-DiT vaccine or 1 mth after admin. of single dose of unconjugated 23- valent pneumococcal polysaccharide vaccine (Pneumovax™ 23), anti-pneumococcal serotypes 1,4,5,6B,7F,9V,14,18C,
Pre&post booster: All vaccine pneumococcal serotypes: Opsono titres*
Antibody (Ab) concentrations >= 0.05, 0.20 µg/mL
Ab concentrations to protein D & seropositivity (S+) status
S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
Occurrence of: solicited local*,general *symptoms within 4 d
Unsolicited adverse events* within 31 d, SAEs (whole study period) *only post booster
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Offenburg, Baden-Wurttemberg, Germany
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, Germany
GSK Investigational Site
Tauberbischofsheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Cham, Bavaria, Germany
...and 41 more locations