Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
Condition: Meningococcal Meningitis; Tetanus; Diphtheria; Pertussis; Poliomyelitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Meningitis, Meningococcal; Meningitis; Tetany
Intervention: Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Intervention description: 0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30); 0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30); 0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 882.0
Sex: All
Minimum age: 4 Years
Maximum age: 7 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal meningitis; Tetanus; Diphtheria; Pertussis; Poliomyelitis; Neisseria meningitidis

Summary:

      The purpose of this study is to evaluate the immunogenicity and safety of the concomitant
      administration of Menactra® vaccine and DAPTACEL® vaccine.

      The main objectives are:

      Immunogenicity:

      To evaluate the antibody responses to both vaccines when Menactra vaccine is given
      concomitantly with DAPTACEL® compared to when either vaccine is given alone.

      Safety:

      To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are
      administered concomitantly compared to when each vaccine is given alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, as determined by medical history and physical examination.

          -  Aged 4 to < 7 years at the time of study vaccination on Day 0.

          -  Informed consent form that has been approved by the Institutional Review Board (IRB)
             and signed/dated by the parent or legal guardian.

          -  Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular
             pertussis (DTaP) series.

        Exclusion Criteria:

          -  Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic,
             psychiatric, hematologic)

          -  Known or suspected impairment of immunologic function

          -  Acute medical illness with or without fever within the last 72 hours or temperature ≥
             100.4°F (≥ 38°C) at the time of enrollment

          -  History of documented invasive meningococcal disease or previous meningococcal
             vaccination

          -  Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or
             4th dose of IPV prior to this study.

          -  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 enrollment.

          -  Received oral or injected antibiotic therapy within the 72 hours prior to any blood
             draw.

          -  Suspected or known hypersensitivity to any of the study vaccine components, history of
             serious or life-threatening reaction to the trial vaccines or a vaccine containing the
             same substances.

          -  Thrombocytopenia or a bleeding disorder contraindicating IM vaccination.

          -  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 physician investigator,
             would pose a health risk to the subject or interfere with the evaluation of the
             vaccine.

          -  Received any other vaccine 30 days prior to the first study vaccination or scheduled
             to receive any vaccination during the course of the study.

          -  Personal or family history of Guillain-Barré Syndrome (GBS).