Meningitis Clinical Trial
Official title:
Antibody Responses to a Reduced Dose of Menomune® in Children Who Previously Received an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, TetraMenD
This study was designed to simulate meningococcal challenge by vaccination with a fractional
combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in
children who were vaccinated with one dose of TetraMenD at least 18 months earlier.
Primary Objective:
To evaluate and compare the antibody responses to a reduced dose of Menomune® in
participants who had previously received a tetravalent meningococcal diphtheria toxoid
conjugate vaccine to those responses in participants who received the same reduced dose of
Menomune® but had not previously received any meningococcal vaccine.
This was a two stage, controlled, open-label trial. Stage I of the trial simulated meningococcal challenge Stage II of the trial evaluated the meningococcal vaccine naïve participants from Stage I, who had also received a reduced dose of Menomune® vaccine in Stage I and were administered a full dose of Menactra® vaccine 6 months later. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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