US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease
Condition: Acellular Pertussis; Tetanus; Diphtheria
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Intervention: Boostrix®; Menactra™
Intervention description: GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.; Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1344.0
Sex: All
Minimum age: 11 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tetanus; pertussis; Prophylaxis; meningococcus; diptheria

Summary:

      New immunization recommendations in the US include vaccination of adolescents against
      pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the
      Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced
      Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed) and MCV4 (Meningococcal conjugate
      vaccine against serotypes A, C, Y and W-135) vaccines be administered to adolescents at the
      same office visit if vaccination with both vaccines is indicated. Therefore, this study is
      designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix
      co-administered with Menactra as compared to the administration of either vaccine alone in
      healthy adolescents 11 - 18 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects as established by medical history and history-directed physical
             examination before entering into the study.

          -  Previously completed routine childhood vaccinations against diphtheria, tetanus and
             pertussis diseases according to the recommended vaccination schedule at the time.

          -  Females of childbearing potential at the time of study entry are required to have a
             negative pregnancy test prior to administration of the dose of vaccine and are
             required to be abstinent or use adequate contraceptive precautions for one month prior
             to vaccination. Subjects also are required to agree to continue such precautions for
             two months after vaccination.

        Exclusion Criteria:

          -  Administration of a pre-school booster of DTP vaccine within the previous 5 years

          -  Administration of a diphteria-tetanus (Td) booster within the previous 5 years

          -  Previous vaccination against N. meningitidis

          -  Hypersensitivity to latex

          -  History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus
             toxoid, diphteria toxoid or pertussis-containing vaccine or any component of the study
             vaccines

          -  History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged
             seizures) within seven days of administration of a previous dose of pertussis vaccine
             taht is not attributable to another identifiable cause

          -  Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy:
             pertussis vaccine should not be administered to individuals with these conditions
             until a treatment regimen has been established and the condition has stabilized

          -  Previous history of Guillain-Barré syndrome