This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy children, 18 to 24 months of age, who received the same vaccine for primary vaccination. Prior to the booster dose, this study will also assess the persistence of antibodies to the vaccine antigen components administered in the primary vaccination course. 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
NONE
Enrollment
148
Intramuscular injection, 1 dose
Intramuscular injection, 1 dose
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina
GSK Investigational Site
León, Nicaragua
Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentration
Time frame: One month after the booster dose
Anti-hepatitis B surface antigen (HBs) antibody concentration
Time frame: One month after the booster dose
Anti-diphtheria antibody concentration
Time frame: One month after the booster dose
Anti-tetanus antibody concentration
Time frame: One month after the booster dose
Anti-Bordetella pertussis (BPT) antibody concentration
Time frame: One month after the booster dose
Anti-PRP antibody concentration
Time frame: Prior to the booster dose
Anti-HBs antibody concentration
Time frame: Prior to the booster dose
Anti-diphtheria antibody concentration
Time frame: Prior to the booster dose
Anti-tetanus antibody concentration
Time frame: Prior to the booster dose
Anti-BPT antibody concentration
Time frame: Prior to the booster dose
Occurrence of solicited symptoms
Time frame: During the 4-day follow-up period after the booster dose
Occurrence of unsolicited symptoms
Time frame: During the 31-day follow-up period after the booster dose
Occurrence of serious adverse events
Time frame: During the entire study period.
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