A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
Condition: Meningococcal Meningitis; Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1128.0
Sex: All
Minimum age: 249 Days
Maximum age: 305 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Menactra vaccine; Meningococcal meningitis; Measles; Mumps; Rubella; Varicella virus; Haemophilus influenzae type b; Pneumococcal conjugate vaccine

Summary:

      This is a Phase III, modified single-blind, randomized, parallel-group, multicenter,
      comparative trial in the United States designed to evaluate the immunogenicity and safety of
      two doses of Menactra vaccine administered alone, and concomitantly with other routine
      pediatric vaccines typically administered between 12 and 15 months of age.

      Primary Objective:

      To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135.

      Secondary Objectives:

      Immunogenicity

        -  To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when
           Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines.

        -  To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when
           Menactra vaccine is administered alone or concomitantly with PCV vaccine.

      Safety

      - To describe the safety profile within 7 and 30 days of each vaccination, and serious
      adverse events (SAEs) throughout the course of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, as determined by medical history and physical examination.

          -  Aged 9 months (249 to 291 days) at the time of enrollment.

          -  The parent or legal guardian has signed and dated the Institutional Review
             Board-approved informed consent form

        Exclusion Criteria:

          -  Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic,
             psychiatric, hematologic, or autoimmune disorders, diabetes, atopic conditions,
             congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas
             of any type, or other malignant neoplasms affecting the bone marrow or lymphatic
             system, acute untreated tuberculosis) that could interfere with trial conduct or
             completion.

          -  Known or suspected impairment of immunologic function.

          -  Acute medical illness within the last 72 hours, or temperature ≥ 100.4 ºF (≥ 38.0 ºC)
             at the time of enrollment.

          -  History of documented invasive meningococcal disease or previous meningococcal
             vaccination.

          -  Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity
             as reported by the parent or legal guardian

          -  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 two weeks prior to enrollment. Topical
             steroids are not included in this exclusion criterion.

          -  Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior
             to the study blood draw. Topical antibiotics or antibiotic drops are not included in
             this exclusion criterion.

          -  Suspected or known hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the study vaccines or a vaccine containing the same
             substances. For ProQuad vaccine recipients, this includes a hypersensitivity to
             gelatin or a history of anaphylactic reactions to neomycin.

          -  Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM)
             vaccination.

          -  Parent or legal guardian unable or unwilling to comply with the study procedures.

          -  Participation in another interventional clinical trial in the 30 days preceding
             enrollment, or participation in another clinical trial involving the investigation of
             a drug, vaccine, medical procedure, or medical device during the subject's trial
             period.

          -  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.

          -  Received any vaccine in the 30-day period prior to receipt of study vaccine, or
             scheduled to receive any vaccination other than influenza vaccination and
             hyposensitization therapy in the 30-day period after receipt of any study vaccine.
             Hyposensitization therapy and influenza vaccination may be received up to two weeks
             before or two weeks after receiving the study vaccines. Subjects should not have
             received their 4th dose of Pneumococcal Conjugate (PCV) or Hib vaccine or their first
             dose of Measles-Mumps-Rubella-Varicella (MMRV) vaccine before enrollment.

          -  Personal or family history of Guillain-Barré Syndrome (GBS).

          -  History of seizures, including febrile seizures, or any other neurologic disorder.

          -  Known hypersensitivity to dry natural rubber latex (pertinent to the Menactra® vaccine
             needle shield)