This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
440
Three doses administered intramuscularly
Three doses administered intramuscularly
Three doses administered intramuscularly
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off value
Time frame: One month after the 2nd dose of the primary vaccination course ( Month 3)
Immunogenicity with respect to the components of the study vaccines in terms of number of seroprotected subjects
Time frame: One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)
Immunogenicity with respect to the components of the study vaccines in terms of number of seropositive subjects
Time frame: One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)
Immunogenicity with respect to the components of the study vaccines in terms of antibody titres
Time frame: One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)
Immunogenicity with respect to the components of the study vaccines in terms of vaccine response
Time frame: One month after the 3rd dose ( Month 9), and one month after the 2nd dose of the primary vaccination course ( Month3)
Occurrence of solicited local symptoms
Time frame: Within 4 days after each vaccination and overall
Occurrence of solicited general symptoms
Time frame: Within 4 days after each vaccination and overall
Occurrence of unsolicited symptoms
Time frame: Within 30 days after each vaccination and overall
Occurrence of serious adverse events
Time frame: Throughout the entire study up to and including 30 days post-vaccination ( Month 0 to Month 9)
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