Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants
Condition: Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type b; Hepatitis B
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis
Intervention: DTaP IPV HB PRP~T vaccine; DTaP-HB-IPV and Haemophilus influenzae type b
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 263.0
Sex: All
Minimum age: 50 Days
Maximum age: 71 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Pertussis; whooping cough; Haemophilus influenzae type b; Hepatitis B; Poliomyelitis

Summary:

      The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP~T
      vaccine has immunological and safety profiles that are comparable to those of the control
      vaccine that is already marketed (Infanrix®Hexa)

      Primary Objective:

      To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP~T combined vaccine induces an immune
      response that is at least as good as the response following Infanrix®Hexa in terms of
      seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months)

      Secondary Objectives:

        -  To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep
           B-PRP~T and Infanrix®Hexa) one month after the third dose of the primary series.

        -  To assess the overall safety in each group one month after each dose of the primary
           series and through the entire study.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Two month old infant (50 to 71 days old) on the day of inclusion, of either gender

          -  Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

          -  Mother negative for Hepatitis B surface Antigen (HBsAg) in approximately the last 30
             days of pregnancy (≥ 36 weeks of amenorrhea) or in the 30 days post partum

          -  Informed consent form signed by both parents. If one or both parent(s) are under 18
             years of age, the subject's grandparent(s) should also sign. An independent witness
             should also sign if the parent(s)/grandparent(s) are illiterate

          -  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 4 weeks preceding the first trial
             vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  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

          -  Congenital or acquired immunodeficiency, or immunosuppressive therapy such as
             long-term (for more than 2 weeks) systemic corticosteroid therapy within the last four
             weeks

          -  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 4 weeks preceding the first trial vaccination

          -  Any planned vaccination during the trial (until Visit 06), except the study vaccines,
             rotavirus vaccine and pneumococcal conjugate vaccines

          -  Documented history of pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or
             Haemophilus influenzae type b infection(s) (confirmed either clinically,
             serologically, or microbiologically)

          -  Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, hepatitis
             B or Haemophilus influenzae type b infection(s)

          -  Known personal or maternal history of Human Immunodeficiency Virus, hepatitis B or
             hepatitis C seropositivity

          -  Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination

          -  History of seizures

          -  Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion.