Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Hepatitis
Intervention: DTaP-IPV-HB-PRP~T vaccine; DTaP-IPV-HB-PRP~T vaccine; DTaP-IPV-HB-PRP~T vaccine; DTaP-HBV-IPV vaccine
Intervention description: 0.5 mL, intramuscular (IM); 0.5 mL, IM; 0.5 mL, IM; 0.5 mL, IM
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1189.0
Sex: All
Minimum age: 2 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Invasive Haemophilus influenzae type b.

Summary:

      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.
    

Eligibility criteria:

        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.