Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
Condition: Meningitis; Meningococcemia; Pertussis; Tetanus; Diphtheria
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Meningitis; Tetany
Intervention: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.; Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.; Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap
Intervention description: Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular; Day 0: 0.5 mL (T dap) + 0.5 mL (Menactra®) Intramuscular; Day 28: Placebo 0.5 mL Intramuscular; Day 0: 0.5 mL (Menactra®)+0.5 mL Placebo, Intramuscular; Day 28: 0.5 mL (T dap) Intramuscular
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1345.0
Sex: All
Minimum age: 11 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcemia; Pertussis; Neisseria meningitidis; Tetanus; Diphtheria

Summary:

      The purpose of this study was to evaluate the immunogenicity and safety of the concomitant
      administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years.

      Primary Objective:

      To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces
      antibody responses that are similar to those observed when each vaccine is given separately.

      Secondary Objective:

      To compare the rates of injection site reactions at the Tdap injection site after Tdap and
      Menactra® vaccines are administered concomitantly to the corresponding rates of reactions
      when Tdap vaccine is administered alone.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Healthy as determined by medical history and physical examination.

          -  Aged ≥ 11 to 17 years at the time of study vaccination on Day 0.

          -  Informed consent form that has been approved by the Institutional Review Board (IRB)
             signed by the parent or legal guardian.

          -  Informed assent form that has been approved by the IRB signed by the subject.

          -  Subject (female) agrees to use measures to prevent pregnancy during the study.

        Exclusion Criteria :

          -  Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic,
             psychiatric, etc.).

          -  Known or suspected impairment of immunologic function.

          -  Acute medical illness with or without fever within the last 72 hours or an oral
             temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrolment.

          -  History of documented invasive meningococcal disease or previous meningococcal
             vaccination.

          -  History of documented infection with Bordetella pertussis, Clostridium tetani, or
             Corynebacterium diphtheriae or vaccination with any tetanus, diphtheria or pertussis
             vaccine within the previous 5 years.

          -  Received either immune globulin or other blood products within the last 3 months; or
             received injected or oral corticosteroids, or other immunomodulator therapy, within 6
             weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids
             lasting <7 days and individuals (e.g., asthmatics) on a short schedule of oral
             steroids lasting 3 to 4 days may be included in the trial as long as they have not
             received more than one course within the last 2 weeks prior to enrolment.

          -  Received antibiotic therapy within the 72 hours prior to vaccination on Day 0.

          -  Received any vaccine 28 days prior to the 1st study vaccination or scheduled to
             receive any vaccination during the course of the study.

          -  Suspected or known hypersensitivity to either of the two study vaccines or their
             components.

          -  Unavailable for the entire study period, or unable to attend the scheduled visits or
             to comply with the study procedures.

          -  Enrolled in another clinical trial.

          -  Diagnosed with any condition, which, in the opinion of the investigator, would pose a
             health risk to the subject or interfere with the evaluation of the vaccine.

          -  For all females, a positive or equivocal urine pregnancy test at time of study
             vaccination.

          -  Nursing mothers.