Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Haemophilus Influenzae Type B Infection
MeSH terms: Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Haemophilus Infections; Hepatitis
Intervention: DTaP-IPV-Hep B-PRP~T vaccine (Batch 1); DTaP-IPV-Hep B-PRP~T vaccine (Batch 2); DTaP-IPV-Hep B-PRP~T vaccine (Batch 3); Infanrix Hexa™
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: None (Open Label)
Enrollment: 881.0
Sex: All
Minimum age: 15 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Invasive Haemophilus influenzae type b.; Haemophilus Influenzae Type B Infection

Summary:

      This is a follow-up of Study A3L11 (NCT00404651).

      Immunogenicity

        -  To describe the antibody persistence following a primary series vaccination of either
           DTaP-IPV-Hep B-PRP~T or Infanrix hexa™.

        -  To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP~T in a subset of
           subjects.

      Safety

      - To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP~T.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Toddlers previously included in Study A3L11 (NCT00404651) who completed the three-dose
             primary series vaccination of either DTaP-IPV-HepB-PRP-T or Infanrix hexa™ at 2, 4 and
             6 months of age

          -  Toddlers of 15 to 18 months (456 to 578 days) of age, inclusive

          -  Informed Consent Form signed by at least one parent or legal representative and two
             mandatory witnesses

          -  Able to attend all scheduled visits and to comply with all trial procedures.

        Exclusion Criteria:

          -  Participation in another clinical trial in the 4 weeks preceding the booster
             vaccination.

          -  Planned participation in another clinical trial during the present trial period.

          -  Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term
             systemic corticosteroid 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 3 months.

          -  Any vaccination in the 4 weeks preceding the booster vaccination.

          -  Any vaccination planned until the next visit.

          -  History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae
             type b or hepatitis B (HB) infection(s) (confirmed either clinically, serologically or
             microbiologically).

          -  Administration of a vaccine against pertussis, tetanus, diphtheria, polio, Hib, and/or
             hepatitis B infection(s) since the end of participation in Study A3L11.

          -  Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular
             vaccination.

          -  Known maternal history of human immunodeficiency virus (HIV), Hepatitis B surface
             antigen (HbsAg) or Hepatitis C seropositivity.

          -  Subjects with any related serious adverse event that occurred following the three-dose
             primary series administration of the investigational vaccine or of the reference
             vaccine in Study A3L11.

          -  History of seizures.

          -  Febrile (temperature ≥38.0°C) or acute illness on the day of inclusion

          -  Known contraindication to further vaccination with a pertussis vaccine, i.e.:
             Encephalopathy; Temperature >40.0°C within 48 hours following a vaccine injection, not
             due to another identifiable cause during the primary series; Inconsolable crying that
             occurred for >3 hours within 48 hours following vaccine injection during the primary
             series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection
             during the primary series; Seizures with or without fever within 3 days following
             vaccine injection.