Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants
Condition: Diphtheria; Polio; Pertussis; Hepatitis B
MeSH terms: Hepatitis B; Whooping Cough; Diphtheria; Hepatitis
Intervention: DTaP-IPV-HB-PRP~T vaccine
Intervention description: 0.5 mL, intramuscular (IM)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 254.0
Sex: All
Minimum age: 15 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B; Polio; Diphtheria; Pertussis; H.influenzae type b

Summary:

      This is a follow-up of Study A3L10 (NCT00315055)

      Immunogenicity

        -  To describe the antibody persistence following a primary series vaccination of either
           DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®.

        -  To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP~T.

      Safety

      - To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP~T.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Toddler previously included in Study A3L10 who completed the three-dose primary series
             vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B® at 2, 3 and 4
             months of age.

          -  Toddler of 15 to 18 months of age (range: 456 to 578 days of age inclusive).

          -  Informed Consent Form signed by the parent(s) or other legal representative(s) and an
             institution official other than an Investigator.

          -  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 second Visit.

          -  History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae
             type b or hepatitis B infection(s) (confirmed either clinically, serologically or
             microbiologically).

          -  Previous booster vaccination against pertussis, tetanus, diphtheria, polio or
             Haemophilus influenzae type b, and hepatitis B infection(s).

          -  Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular
             vaccination.

          -  Any vaccine-related serious adverse event that occurred following the three-dose
             primary series administration of the investigational vaccine or of the reference
             vaccine in Study A3L10 (NCT00315055).

          -  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.