Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Tritanrix™- HepB; Hiberix™; Mencevax™ ACW
Intervention description: One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months; One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months; One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: All
Minimum age: 15 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: meningococcal serogroups A and C diseases; tetanus; hepatitis B; pertussis; Haemophilus influenzae type b; meningococcal vaccine; Prophylaxis diphtheria

Summary:

      The purpose of this study is to assess the safety and reactogenicity of a booster dose of
      diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b
      vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and
      reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal
      vaccine (ACW) at 24 to 30 m in primed subjects.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  A male or female between, and including, 15 and 18 months of age at the time of
             vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Having participated in the primary vaccination study (CPMS N° 759346/007).

        Exclusion criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine within 30 days preceding the vaccination, or planned use during the
             study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to vaccination.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within 30 days of vaccination.

          -  Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus
             influenzae type b (Hib) and/or meningococcal serogroups A, C or W disease, after the
             date of the study conclusion visit of the primary vaccination study (CPMS N°
             759346/007).

          -  History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal
             serogroup A, C or W disease.

          -  Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or
             meningococcal serogroup A, C or W disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  A family history of congenital or hereditary immunodeficiency.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines administered in the study.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures including febrile seizures in infancy.

          -  Acute disease at the time of enrolment.

          -  Axillary temperature ≥ 37.5°C at the time of vaccination.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the vaccination or planned administration during the study period.

          -  Anaphylactic reaction following the administration of vaccine in the primary
             vaccination study.

          -  Known hypersensitivity to any component of the vaccine, or subjects having shown signs
             of hypersensitivity after previous administration of diphtheria, tetanus, pertussis,
             hepatitis B, Hib or meningococcal vaccines.