Tetanus Clinical Trial
Official title:
An Immunogenicity and Safety Evaluation of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) When Administered to Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age.
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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