A clinical study on Pentavalent vaccine

INTERVENTION: Intervention1: DTwP‐HB+Hib vaccine of SIIL: 3 doses of 0.5ml at 6, 10, 14 weeks Control Intervention1: DTwP‐HB+Hib vaccine of SIIL: 3 doses of 0.5ml at 6, 10, 14 weeks CONDITION: Safety and immunogenicity of DTwP‐HB+Hib vaccine PRIMARY OUTCOME: To assess the immunogenicity‐efficacy following administration of the Pentavac (DTP‐HB+Hib) vaccine manufactured using scaled up process and its comparison with the one produced by the small scale process in Indian infants.‐‐‐‐‐‐Timepoint: Pre and post‐vaccination SECONDARY OUTCOME: To assess reactogenicity of Pentavac vaccine manufactured using scaled up process and its comparison with the one produced by the small scale process.‐‐‐‐‐‐Timepoint: One month after each dose of the vaccine INCLUSION CRITERIA: Healthy children of either sex aged 6 to 8 weeks at the time of 1st vaccination. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Written, Explained, Signed informed consent of the child parents or guardian. Born after normal gestational period (36‐42 weeks). Born to mothers sero‐negative for HBs Ag (as per current antenatal records or test conducted after informed consent of mother). Born to mothers sero‐negative for HIV (as per current antenatal records or test conducted after informed consent of mother). No evidence of any infection or fever. Available for an observation period of minimum 16 weeks.