Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children
Condition: Whole Cell Pertussis; Tetanus; Hepatitis B; Diphtheria; Haemophilus Influenzae Type b; Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis; Tetany
Intervention: Tritanrix-HepB/Hib-MenAC; Tritanrix-HepB/Hiberix; Mencevax-ACWY
Intervention description: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine; Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine; Meningococcal Serogroups A, C, W-135 and Y Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 798.0
Sex: All
Minimum age: 427 Days
Maximum age: 577 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hib & Neisseria meningitidis serogroups A & C diseases

Summary:

      This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP)
      booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or
      Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24 months in a single-blind manner so
      that the subjects' parents will not know which vaccine was administered to their child. In
      the Mencevax ACWY phase at 24-30 months, a dose of Mencevax ACWY will be given in an open
      manner to only those subjects who received less than 4 doses of Tritanrix-HepB/Hib-MenAC. No
      blood samples will be taken in this safety study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent obtained from the parent or guardian of a healthy male or
             female child between, and including 15 and 18 months age (Philippines)/ 15 and 24
             months age (Thailand) at the time of vaccination and who have previously received a
             3-dose primary vaccination in the studies DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004)
             or DTPW-HBV=HIB-MENAC-TT-013 (eTrack No. 100791).

        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 (> 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. Note: Oral poliovirus vaccine can be given
             concomitantly.

          -  Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus
             influenzae type b (Hib) and/or meningococcal serogroups A and C disease, after the
             date of the study conclusion visit of the primary vaccination study.