Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth

Inclusion Criteria:

• Aged 61 to 91 days on the day of the first study visit
• Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥2.5 kg
• Informed consent form has been signed and dated by the parent(s) or other legallyacceptable representative (and by an independent witness if required by localregulations)
• Subject and parent/legally acceptable representative are able to attend all scheduledvisits and to comply with all trial procedures
• Have received one dose of Hep B vaccine at birth or within 1 week after birth (documented according to the national recommendations).

Exclusion Criteria:

• Participation in the 4 weeks preceding the first trial vaccination or plannedparticipation during the present trial period in another clinical trial investigatinga vaccine, drug, medical device, or medical procedure
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or plannedreceipt of any other vaccine within the period from 8 days before to 8 days after eachsubsequent trial vaccination except for Bacille Calmette Guerin (BCG) vaccination (anyadministration of oral poliovirus vaccine (OPV) in the context of oral poliovirusvaccine-national immunization days (NIDs) does not fall within the scope of thisexclusion criterion)
• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitisB (except the dose of Hep B vaccine given at birth or within 1 week after birth)diseases or Haemophilus influenzae type b infection with either the trial vaccine oranother vaccine (any administration of OPV in the context of OPV-NIDs does not fallwithin the scope of this exclusion criterion)
• Past or current receipt of immune globulins, blood or blood-derived products orplanned administration during the trial
• Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy sincebirth; or long-term systemic corticosteroid therapy (prednisone or equivalent for morethan 2 consecutive weeks since birth)
• History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilusinfluenzae type b infections (confirmed either clinically, serologically ormicrobiologically)
• Known personal or maternal history of Human Immunodeficiency Virus (HIV), or hepatitisC seropositivity
• Known systemic hypersensitivity to any of the vaccine components, or history of alife-threatening reaction to the vaccine used in the trial or to a vaccine containingany of the same substances
• Known thrombocytopenia, as reported by the parent/legally acceptable representative
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,contraindicating intramuscular vaccination
• History of seizures
• In an emergency setting, or hospitalized involuntarily
• Chronic illness that, in the opinion of the investigator, is at a stage where it mightinterfere with trial conduct or completion
• Moderate or severe acute illness/infection (according to investigator judgment) on theday of vaccination or febrile illness (temperature ≥38.0°C). A prospective subjectshould not be included in the study until the condition has resolved or the febrileevent has subsided
• Identified as a natural or adopted child of the Investigator, relatives or employeewith direct involvement in the proposed study.