Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
Condition: Meningococcal Meningitis; Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Meningitis, Meningococcal; Meningitis
Intervention: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Measles-mumps-rubella-varicella vaccine; Routine paediatric vaccine - Pneumococcal conjugate (PCV); Routine paediatric vaccine - Hepatitis A
Intervention description: 0.5 mL, IM at age 9 and 12 months; 0.5 mL, intramuscular at 12 months of age; 0.5 mL, Intramuscular at age 12 months; 0.5 mL, Intramuscular at age 12 months
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1378.0
Sex: All
Minimum age: 9 Months
Maximum age: 12 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Menactra® vaccine; Meningococcal meningitis; Measles; Mumps; Rubella; Varicella virus; Haemophilus influenzae type b; Pneumococcal conjugate vaccine

Summary:

      This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in
      subjects at 9 months and at 12 months of age when the second dose is given concomitantly with
      other pediatric vaccines routinely administered in the US.

      Safety Objective:

      To describe the safety profile of two doses of Menactra® Vaccine.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Healthy, as determined by medical history and physical examination

          -  Aged 9 months (249 to 305 days) or 12 months (365 to 400 days) at the time of
             enrollment

          -  The parent or legal guardian has signed and dated the Independent Ethics Committee
             (IEC)-/Institutional Review Board (IRB)-approved informed consent form.

        Exclusion Criteria :

          -  Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic,
             psychiatric, hematologic, 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 a temperature ≥ 100.4ºF (≥ 38.0ºC)
             at the time of enrollment.

          -  History of documented invasive meningococcal disease or previous meningococcal
             vaccination.

          -  Has received the fourth dose of Prevnar, or the first dose of measles-mumps-rubella
             (MMR), varicella, or hepatitis A (HepA) vaccine.

          -  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.

          -  Suspected or known hypersensitivity to any of the vaccine components.

          -  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 the study vaccine(s), or
             scheduled to receive any vaccination other than influenza vaccination and
             hyposensitization therapy in the 30-day period after receipt of the study vaccine(s).

          -  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.

        For the subjects scheduled to provide blood samples:

        - Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to
        either of the study blood draws. Topical antibiotics and antibiotic drops are not included
        in this exclusion criterion.