Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age
Condition: Meningitis; Meningococcal Infection; Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Serotype b (Hib)
MeSH terms: Whooping Cough; Diphtheria; Meningococcal Infections; Meningitis
Intervention: Meningococcal polysaccharide diphtheria toxoid conjugate; Meningococcal polysaccharide diphtheria toxoid conjugate + Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed; Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1394.0
Sex: All
Minimum age: 9 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Infection; Diphtheria; Pertussis; Menactra®; Pentacel®

Summary:

      The aim of the study is to further characterize the safety and immunogenicity of Menactra® in
      the population <2 years of age when administered alone and when the second dose is
      administered concomitantly with the 4th dose of Pentacel®, a licensed pediatric vaccine.

      Primary Objectives:

        -  To evaluate and compare the antibody responses to meningococcal serogroups A, C, Y, and
           W-135 induced by 2 injections of Menactra® in subjects aged 9 months at the first
           vaccination visit and 15 to 18 months at the second vaccination visit.

        -  To evaluate and compare the antibody responses to Pertussis (pertussis toxoid [PT],
           filamentous haemagglutinin [FHA] and pertactin [PRN]) antigens induced by a dose of
           Pentacel® when administered concomitantly with Menactra® to those elicited by a dose of
           Pentacel® administered alone.

        -  To evaluate and compare the antibody responses to polyribosylribitol phosphate (PRP),
           tetanus and diphtheria antigens induced by a dose of Pentacel® when administered
           concomitantly with Menactra® to those elicited by a dose of Pentacel® alone.

      Observational Objectives:

        -  To describe the safety profile (immediate unsolicited AEs within 30 minutes of each
           trial vaccination, solicited reactions within 7 days of each vaccination, unsolicited
           AEs within 30 days of each vaccination, and serious adverse events [SAEs] throughout the
           course of the trial from Day 0 up to Day 30 after the last trial vaccination[s]) in all
           trial groups

        -  To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135,
           measured by SBA HC, 30 days after the second Menactra® administration

        -  To describe the antibody responses to Pentacel® (PT, FHA, PRN, FIM, diphtheria, tetanus,
           polio, PRP) measured by enzyme-linked immunosorbent assay (ELISA), radioimmunoassay
           (RIA), or functional assays.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 9 months (249 to 305 days) for Groups 1 and 2, or 15 to 18 months (420 to 570
             days) for Group 3 on the day of the first trial visit

          -  Informed consent form has been signed and dated by the parent(s) or other legally
             acceptable representative

          -  Received 3 doses of any DTaP-containing vaccines

          -  Received 3 doses of a Hib-containing vaccine, or 2 doses if the subject received
             PRP-OMP (PedvaxHIB® or Comvax®[HepB-Hib])

          -  Received at least 3 doses of a CRM197-based pneumococcal conjugate vaccine
             (Pneumococcal conjugate vaccine [PCV] or 13-Valent pneumococcal conjugate vaccine
             [PCV13])

          -  Subject and parent/ legally acceptable representative are able to attend all scheduled
             visits and to comply with all trial procedures.

        Exclusion Criteria:

          -  Participation in the 4 weeks preceding the first trial vaccination or planned
             participation during the present trial period in another clinical trial investigating
             a vaccine, drug, medical device, or medical procedure

          -  Receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned
             receipt of any vaccine in the 4 weeks following each trial vaccination, except for
             influenza vaccination, which may be received at least 2 weeks before or after the
             trial vaccination(s)

          -  Vaccination against meningococcal disease with either the trial vaccine or another
             vaccine, or receipt of the 4th dose of any DTaP-containing vaccines, receipt of the
             4th dose of a Hib-containing vaccine, or receipt of the 3rd dose of PRP-OMP
             (PedvaxHIB® or Comvax® [Hep B-Hib]) prior to enrollment or during the conduction of
             the trial, except for Group 1 subjects, who may receive Hib vaccine at 12 months

          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
             within the preceding 6 months; or long-term systemic corticosteroid therapy
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
             Topical steroids are not included in this exclusion criterion

          -  History of invasive meningococcal infection, confirmed either clinically,
             serologically, or microbiologically

          -  Personal history of Guillain-Barré Syndrome

          -  History of encephalopathy (e.g., coma, decreased level of consciousness, prolonged
             seizures) within 7 days of a previous dose of a pertussis containing vaccine that is
             not attributable to another identifiable cause

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to one of the vaccines used in the trial or to a vaccine
             containing any of the same substances

          -  Known thrombocytopenia, as reported by the parent/ legally acceptable representative,
             contraindicating intramuscular vaccination

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination

          -  In an emergency setting or hospitalized involuntarily

          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  Moderate or severe acute illness/ infection (according to investigator judgment) or
             febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]) on the day of vaccination. A
             prospective subject should not be included in the trial until the condition has
             resolved or the febrile event has subsided

          -  Receipt of oral or injectable antibiotic therapy within 72 hours prior to any trial
             blood draw (topical antibiotics, drops, or ointments are not included in this
             criterion)

          -  Identified as a natural or adopted child of the Investigator or employee with direct
             involvement in the proposed trial.