At a glance
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A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers
In Brief
A Phase 2 clinical trial evaluating Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine and Meningococcal Polysaccharide groups A, C, W-135 and Y Conjugate Vaccine for Meningitis and 2 related conditions. Completed, enrolled 188 participants across 8 sites.
Detailed Summary
The purpose of the study was to evaluate the immunogenicity and safety profile of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate vaccine when given alone compared to that of the licensed Meningococcal groups A, C, W 135 and Y (NIMENRIX®) Conjugate vaccine. Observational objectives: * To evaluate the antibody responses to the antigens (serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine and NIMENRIX® measured by serum bactericidal assay using baby rabbit complement (rSBA) and by serum bactericidal assay using human complement (hSBA) * To evaluate the antibody responses against tetanus in participants who received MenACYW Conjugate vaccine or NIMENRIX® vaccine * To evaluate the safety profile of MenACYW Conjugate vaccine and NIMENRIX®
Study Details
Timeline
Interventions
0.5 milliliter (mL), Intramuscular (IM)
0.5 mL, IM