DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants

Inclusion Criteria:

(Screening Criteria for the participants mother)

• At least 18 years of age at the time of the Screening blood sample draw
• Self-reported or maternity-reported HIV infection in the mother Inclusion Criteria:
• Born to an adult mother and aged 35 to 56 days (between 5 and 8 weeks of age) on theday of inclusion
• Group A participants must be HIV infected, as documented through the results of apolymerase chain reaction (PCR) test, and following an anti-retroviral therapyaccording to the national recommendations; and Group B participants must be HIVexposed uninfected infants, as documented through the results of a PCR test.
• Born with a birth weight ≥ 2.0 kg
• Informed consent form signed by the parent(s)/legal guardian(s) and by one independentwitness if the parent(s)/legal guardian(s) is illiterate
• Participants and parent(s)/legal guardian(s) are able to attend all scheduled visitsand to comply with all trial procedures.

Exclusion Criteria:

• Participation in another clinical trial of an investigational product in the 4 weekspreceding the trial inclusion (receipt of study vaccine) or planned participationduring the present trial period in another clinical trial investigating a vaccine,drug, medical device, or medical procedure
• Group A participants diagnosed with a chronic condition, except HIV infection, or anyexperience of blood or blood-derived products received or experience ofthrombocytopenia or bleeding disorder; and Group B participants diagnosed with chronicillness or any experience of blood or blood-derived products received or experience ofthrombocytopenia or bleeding disorder.
• Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (oralpolio vaccine [OPV] given at birth does not constitute an exclusion criteria),hepatitis B (a birth dose of Hep B vaccine does not constitute an exclusion criteria)diseases or Hib infection with the trial vaccine or another vaccine. Previousvaccination with Bacillus Calmette-Guerin (BCG) is not considered an exclusioncriterion
• History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilusinfluenzae type b infections (confirmed either clinically, serologically ormicrobiologically)
• History of seizures or history of uncontrolled neurologic disorder or uncontrolledepilepsy until treatment for the condition has been established, the condition hasstabilized and the benefit clearly outweighs the risk
• Known systemic hypersensitivity to any of the vaccine components, or history of alife-threatening reaction to the vaccine(s) used in the trial or to a vaccinecontaining any of the same substances
• Febrile (axillary temperature ≥ 38°C) or acute illness on the day of inclusion (temporary contraindication).