Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age
Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar + DTPa-HBV-IPV/Hib
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
120
1 month post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL
1 month post dose 3: For all vaccine pneumococcal serotypes: Opsono titres
Antibody (Ab) concns >= 0.05 µg/mL
Ab concns to protein D and seropositivity (S+) status
S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
After each vaccination, occurrence of: solicited local, general symptoms within 4 days
Unsolicited adverse events within 31 days, SAEs (whole study period)
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GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Marbach, Baden-Wurttemberg, Germany
GSK Investigational Site
Nördlingen, Bavaria, Germany
GSK Investigational Site
Tutzing, Bavaria, Germany
GSK Investigational Site
Wiesbaden, Hesse, Germany
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany
GSK Investigational Site
Waren, Mecklenburg-Vorpommern, Germany
GSK Investigational Site
Bad Oeynhausen, North Rhine-Westphalia, Germany
GSK Investigational Site
Erkrath, North Rhine-Westphalia, Germany
GSK Investigational Site
Goch, North Rhine-Westphalia, Germany
...and 22 more locations