Meningitis Clinical Trial
Official title:
Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135
The objective of this trial is to study the administration of the Menomune vaccine given
intradermally and low-dose subcutaneously versus standard subcutaneously. This study will
describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard
dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose)
and a low dose (2/10th of standard dose) subcutaneously.
The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal
(ID) routes at different dosages
This trial will provide a proof of concept that a dose range of Menomune given ID can induce
an immune response that is comparable to standard dosing by the SC route, and is equivalent
or superior to a low dose given SC.
Subjects will be randomized according to a computer-generated randomization schedule to
receive the vaccine by SC injection or by ID injection at different dosages.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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