Infections, Streptococcal Clinical Trial
Official title:
To Assess the Safety, Reactogenicity & Immunogenicity of a 4th Dose of GSK Biologicals' Pneumococcal Vaccine or Prevenar™ in Children (12-18 Months) Previously Vaccinated in the Primary Study NCT00307554 With Either Pneumococcal Vaccine or Prevenar™
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of
GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of
age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553.
Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization
course in study 105553 (NCT00307554). The immune response to a booster dose of GSK
Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to
subjects not primed with GSK Biologicals' vaccine but with Prevenar™.
The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal
conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children
primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of
children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal
conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib
vaccine.
n/a
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