This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
80
Three doses administered intramuscularly
One dose administered orally
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 values
Time frame: One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9)
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 values
Time frame: Before the first dose ( Month 0 )
Immunogenicity with respect to the components of the study vaccine in terms of antibody titers
Time frame: Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9).
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with vaccine response
Time frame: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
Immunogenicity with respect to the components of the study vaccine in terms of antibody titres greater than or equal to cut off values
Time frame: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
Number of subjects with solicited and unsolicited adverse events
Time frame: After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall
Number of subjects with serious adverse events
Time frame: During the study period (Month 0 to Month 9)
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