Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants
Condition: Diphtheria; Tetanus; Pertussis; Poliomyelitis; Hepatitis B
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Hepatitis
Intervention: DTaP-IPV//PRP~T combined vaccine; DTaP-IPV//PRP~T combined vaccine
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 458.0
Sex: All
Minimum age: 510 Days
Maximum age: 578 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Pertussis; whooping cough; Haemophilus influenzae type b; Hepatitis B; Poliomyelitis

Summary:

      This study will assess both the antibody persistence of the investigational vaccine and the
      immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers
      who participated in an earlier study in order to determine if they are still protected before
      they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the
      quality of the induced immune memory in response to a booster dose of the same vaccine as in
      the primary series.

      Primary Objective:

      To describe the antibody persistence at 18 months of age and the booster effect of a dose of
      PENTAXIM™ on immunogenicity.

      Secondary objective:

      To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by
      the vaccines received during the primary series.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Toddler at 18 months of age (range: 510 days to 578 days of age inclusive)

          -  Participated in study A3L02 (NCT00831311) and has completed the three-dose primary
             series with either diphtheria, tetanus, pertussis (2-component acellular), recombinant
             Hepatitis B Hansenula and poliomyelitis vaccine adsorbed, and Haemophilus influenzae
             type b vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T) or PENTAXIM™ and
             ENGERIX B® PEDIATRICO at 2, 4, and 6 months of age

          -  Written informed consent form signed by at least one parent or by a legal
             representative and an independent witness

          -  Able to attend all scheduled visits and to comply with all trial procedures.

        Exclusion Criteria:

          -  Participation in another clinical trial in the four weeks preceding the trial
             vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer
             chemotherapy or radiation therapy within the preceding 6 months or long-term systemic
             corticosteroids therapy

          -  Systemic hypersensitivity to any of the vaccine components or history of a
             life-threatening reaction to 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 in the last six months

          -  Any vaccination in the four weeks preceding the trial

          -  Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus
             influenzae type b, polio, or hepatitis B antigen, since the end of the primary series

          -  History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b,
             polio, or hepatitis B infection(s) (confirmed either clinically, serologically, or
             microbiologically)

          -  Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination

          -  History of seizures

          -  Fever (axillary temperature ≥37.4°C or equivalent rectal temperature ≥38.0°C) or acute
             illness on the day of inclusion

          -  Known contraindication to further vaccination with a pertussis vaccine such as:

          -  Encephalopathy; Inconsolable crying for >3 hours within 48 hours following vaccine
             injection

          -  Hypotonic hyporesponsive episode within 48 hours following vaccine injection

          -  Seizures with or without fever within three days following vaccine injection

          -  Axillary temperature >39.4°C or equivalent rectal temperature > 40.0°C within 48 hours
             following vaccine injection.