In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups: * one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age * the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of age
DTPa-HBV-IPV/Hib vaccine will be administered at two schedules (i.e. 6-10-14 weeks of age OR 2-4-6 months of age) in infants who were previously vaccinated with hepatitis B vaccine at birth. The duration of the study will be approximately 3 months for each subject who will receive vaccination at 6-10-14 weeks of age and approximately 5 months for each subject who will receive vaccination at 2-4-6 months of age. Intervention name: Diphteria, tetanus, acellular pertussis, hepatitis B, poliovirus types 1, 2, 3 \& Haemophilus influenzae type b vaccine
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
224
GSK Investigational Site
Bangalore, India
GSK Investigational Site
Baroda, India
GSK Investigational Site
Goa, India
GSK Investigational Site
New Delhi, India
1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers
1M post-dose 3, antibody levels against all antigens
After each dose, solicited (day 0-3, local and general) and unsolicited (day 0-30) events
Serious adverse events (SAEs) for entire study
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