Study of Sanofi Pasteur's DTaP-IPV Hep B-PRP-T Combined Vaccine in Infants Who Previously Received Hepatitis B Vaccine

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 orplanned receipt of any other vaccine within the period from 8 days before to 8 daysafter each subsequent trial vaccination except for Bacille Calmette Guerin (BCG)vaccination (any administration of oral poliovirus vaccine (OPV) in the context oforal poliovirus vaccine-national immunization days (NIDs) does not fall within thescope of this exclusion 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 therapysince birth; or long-term systemic corticosteroid therapy (prednisone or equivalentfor more than 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), orhepatitis C 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 itmight interfere with trial conduct or completion

• Moderate or severe acute illness/infection (according to investigator judgment) onthe day of vaccination or febrile illness (temperature ≥38.0°C). A prospectivesubject should not be included in the study until the condition has resolved or thefebrile event has subsided

• Identified as a natural or adopted child of the Investigator, relatives or employeewith direct involvement in the proposed study.