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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Participants will be vaccinated according to their randomized groups at age 9 months and at
      age 15 to 18 months. They will undergo immunogenicity assessment and safety monitoring
      post-vaccination.
    

Intervention name(s): 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 type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Menactra®; Menactra®; Pentacel®; Pentacel®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal Infection; Diphtheria; Pertussis; Menactra®; Pentacel®