Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants
Condition: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis
MeSH terms: Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Whooping Cough; Hepatitis
Intervention: DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide; DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide; DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine
Intervention description: 0.5 mL, Intramuscular each into the right and left deltoid muscle; 0.5 mL, Intramuscular each into the right and left deltoid muscle; 0.5 mL (each), Intramuscular each into the right and left deltoid muscle
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1106.0
Sex: All
Minimum age: 12 Months
Maximum age: 24 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis; Pediatric combined vaccine; Invasive Hib infections

Summary:

      This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722).
      The objectives are:

        -  To describe the antibody persistence to any antigen contained in the investigational
           DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose

        -  To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep
           B-PRP-T or Infanrix hexa™ vaccine.

        -  To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 12 to 24 months on the day of inclusion.

          -  Informed consent form has been signed and dated by the parent(s) or other legally
             acceptable representative (and by an independent witness(es) if required by local
             regulations).

          -  Subject and parent/guardian are able to attend all scheduled visits and to comply with
             all trial procedures.

          -  Toddlers previously included in Study A3L24 who completed the three-dose primary
             series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™ at 2,4 and 6
             months of age according to protocol (both concomitantly administered with Prevenar™
             and Rotarix™).

        Exclusion Criteria:

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or medical procedure in the 4 weeks preceding the booster vaccinations.

          -  Planned participation in another clinical trial during the present trial period.

          -  Receipt of any vaccine in the 4 weeks preceding the booster vaccinations, except in
             case of pandemic influenza vaccination, which may be received at least two weeks
             before the study vaccines.

          -  Planned receipt of any vaccine in the 4 weeks following the trial vaccinations.

          -  Previous booster vaccination against pertussis, tetanus, diphtheria, poliomyelitis,
             Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s) with either
             the trial vaccine or another vaccine.

          -  Receipt of blood or blood-derived products in the past 3 months, which might interfere
             with assessment of the immune response.

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
             the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or
             equivalent for more than 2 consecutive weeks within the past 3 months).

          -  Laboratory-confirmed or clinical suspicion of personal or maternal seropositivity for
             Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C, as reported by the
             parent/guardian.

          -  History of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type
             b, hepatitis B and pneumococcal infection(s), confirmed either clinically,
             serologically, or microbiologically.

          -  At high risk for opportunistic infection during the trial.

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine(s) used in the trial or to a vaccine
             containing any of the same substances.

          -  History of contraindication to receipt of pertussis-containing vaccine.

          -  Laboratory-confirmed or clinical suspicion of thrombocytopenia contraindicating
             Intramuscular vaccination.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination.

          -  History of seizures .

          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
             interfere with trial conduct or completion.

          -  Receipt of oral or injected antibiotic therapy within 72 hours prior to the first
             blood draw

          -  Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection
             (according to investigator judgment) on the day of vaccination.