Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

Lot to Lot Consistency Study of DTaP-IPV-Hep B-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Mexican Infants

The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.

The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series.

The secondary objectives are:

• To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series
• To assess the overall safety in each group one month after the third dose of the primary series.

Inclusion Criteria :

• Two months old infants on the day of inclusion
• Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
• Informed consent form signed by one or both parents or by the guardian and two independent witnesses
• Able to attend all scheduled visits and to comply with all trial procedures
• Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.

Exclusion Criteria :

• Participation in another clinical trial in the four weeks preceding the (first) trial vaccination
• Planned participation in another clinical trial during the present trial period
• Congenital or acquired immunodeficiency
• Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
• Chronic illness at a stage that could interfere with trial conduct or completion
• Blood or blood-derived products received since birth
• Any vaccination in the four weeks preceding the first trial visit
• Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
• Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
• Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
• Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity
• Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
• History of seizures
• Febrile (rectal equivalent temperature ≥ 38.0°C) or acute illness on the day of inclusion.