A phase III clinical trial to study the safety and immunogenicity of BEs combined pentavalent DTwP-rHepB-HIB liquid vaccine administered to 6-8 week old healthy Infants of either gender in comparison with a marketed vaccine

INTERVENTION: Intervention1: Combined pentavalent DTwP‐rHepB‐HIB liquid vaccine of BE Ltd: 0.5mL/dose administered intramuscularly at 6‐10‐14 weeks in three dose EPI schedule. Control Intervention1: Shan5 (Combined DTwP‐rHepB‐HIB Liquid Vaccine): 0.5mL/dose administered intramuscularly at 6‐10‐14 weeks in three dose EPI schedule. CONDITION: Preventive protection against Diphtheria, Tetanus, Petussis, Hepatitis‐B and Haemophilus Influenzae type B diseases. PRIMARY OUTCOME: Primary Endpoint ‐ Proportion of subjects achieving seroprotection rates in antibody titres against all the five components in each treatment group at Day 84. ; ; ‐‐‐‐‐‐Timepoint: By the end of 84th day from 1st vaccination. SECONDARY OUTCOME: Antibody titres rise against each of the five antigen component‐‐‐‐‐‐Timepoint: GMTs estimated both at baseline 0 day and again on 84th day. Occurance of both solicited and unsolicited local and systemic adverse events‐‐‐‐‐‐Timepoint: 1. First 60 minutes post vaccination.; 2. until 7 days post vaccination through diary.; 3. upto 28th day post vaccination.; 4. SAEs over the entire course of the study. Proportion of subjects achieving 4‐fold rise of antibody titres above the cutoff levels.‐‐‐‐‐‐Timepoint: Estimated at 84th day after 1st vaccination INCLUSION CRITERIA: 1.Intended subjects will be healthy infants between 6 to8 weeks of age that is 42 to 56 days of age,both days inclusive of either gender at the time of 1st vaccination. 2.Written informed consent obtained from the subjectâ??s parents or legal representative or guardian. 3.Healthy infants with weight greater than or equal to 3300 gms at the time of screening. 4.Good clinical condition established by medical history and physical examination with no acute disease, infection or high temperature that is greater then 38.5 degrees C axillary temperature. 5.Healthy infants born to mothers seronegative to HBV and HIV as confirmed by laboratory tests on the mother or based on maternity discharge summary. 6.Subjects or their mothers not participating in any other trials. 7.Infants without contraindications or precautionary circumstances for participating in the trial 8.Ability of the subjectâ??s parent or le