A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American 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 Vaccine; DTaP-IPV-Hep B-PRP-T Vaccine; DTaP-IPV-Hep B-PRP-T Vaccine; DTaP-Hep B-IPV vaccine
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1375.0
Sex: All
Minimum age: 55 Days
Maximum age: 65 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Whooping cough; Hepatitis B; Poliomyelitis; Diphtheria-Tetanus-acellular Pertussis Vaccines

Summary:

      The purpose of this study is to generate immunogenicity and safety data of an investigational
      hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when
      given along with Prevenar™ and Rotarix™ vaccines.

      Primary Objectives:

        -  To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T
           vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with
           Prevenar™ and Rotarix™, in terms of immunoresponses.

        -  To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the
           licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™.

      Secondary Objectives:

        -  To describe in each group the immunogenicity parameters for all antigens for each
           vaccine

        -  To assess the safety profile in terms of solicited and unsolicited adverse events and
           serious adverse events in each group for each vaccine.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Two month old infants (55 to 65 days old) 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 legally acceptable
             representative as per local requirements.

          -  Able to attend all scheduled visits and to comply with all trial procedures.

          -  Received Hepatitis B and Bacille de Calmette-Guérin (BCG) vaccines between birth and
             one month of life in agreement with the national immunization calendar.

        Exclusion Criteria :

          -  Participation in another clinical trial in the 4 weeks preceding the first trial
             vaccination.

          -  Planned participation in another clinical trial during the present trial period.

          -  Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy,
             or long-term systemic corticosteroid therapy.

          -  Known 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, in
             the opinion of the Investigator.

          -  Blood or blood-derived products received since birth that might interfere with the
             assessment of the immune response.

          -  Any vaccination before trial vaccination (except Hepatitis B and Bacille de Calmette
             Guérin given at birth).

          -  Any planned vaccination until 1 month after the last trial vaccination (except the
             study vaccines, rotavirus and pneumococcal conjugated vaccines).

          -  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 pertussis, tetanus, diphtheria, poliomyelitis, or
             Haemophilus influenzae type b infections.

          -  Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B
             surface antigen (HBsAg) or hepatitis C seropositivity.

          -  Known coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion
             contraindicating intramuscular (IM) vaccination.

          -  History of seizures or encephalopathy.

          -  Febrile illness (temperature ≥ 38.0°C), or moderate or severe acute illness/infection
             on the day of inclusion, according to the Investigator judgment.