Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV

Inclusion Criteria:

• Male or female infants aged 6-8 weeks at the time of first vaccination.

• Infants with good health, as determined by the medical history, physical examinationand clinical judgment of the Investigator.

• Informed consent form signed by at least one parent.

• Infants born at full term pregnancy (≥ 37 weeks).

• Infants with weight-for-length z-score ≥ -2 standard deviation (SD) at the time ofenrolment.

• Willingness of subjects' parent to comply with the requirements of the protocol.

Exclusion Criteria:

• History of diphtheria/ tetanus/ pertussis/ hepatitis B/ Haemophilus Influenzae typeb/ poliomyelitis infection(s).

• Presence of fever ≥ 38°C/ 100.4°F.

• Acute illness of moderate to severe intensity according to the clinical judgment ofthe investigator .

• Receipt of antibiotics in the past 3 days

• Previous vaccination or planned receipt of any vaccine against diphtheria, tetanus,pertussis, hepatitis B (except birth dose), poliomyelitis (except OPV birth dose) orHaemophilus Influenzae type b infection apart from trial vaccines during the studyperiod.

• Administration of any vaccine (except OPV during government immunization campaign)in the 4 weeks preceding the first trial vaccination.

• History of major congenital defects or illness that require medical therapy, asdetermined by medical history or clinical assessment.

• History of any clinically significant chronic disease that in the opinion of theInvestigator, might interfere with the evaluation of the study objectives.

• History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergyto any vaccine or components of study vaccine.

• Infants with known or suspected impairment of the immune function, or thosereceiving immunosuppressive therapy such as anti-cancer chemotherapy or radiationtherapy or received immunosuppressive therapy prior to study entry

• Presence of evolving or changing neurological disorder or infant with a history ofseizures and/or encephalopathy.

• Known thrombocytopenia or a bleeding disorder.

• Known personal or maternal history of HIV, Hepatitis B or Hepatitis Cseropositivity.

• Planned surgery during the study.

• Receipt of blood or blood-derived products or immunoglobulins or plannedadministration during the trial which might interfere with the assessment of theimmune response.

• Participation in another clinical trial 4 weeks preceding the trial enrolment orplanned participation during the present trial period in another clinical trial.

• Infants whose families are planning to leave the area of the study site before theend of the study period.