drugset / Trial / NCT00850603
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
RandomizedParallel-groupOpen-labelPrevention
Summary
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
Timeline
- Start
- 2002-10
- Primary completion
- 2003-05
- Completion
- 2004-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined | Vaccine | 0.05 ml | Subcutaneous |
| Subject | Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined | Vaccine | 0.1 ml | Subcutaneous |
| Subject | Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined | Vaccine | 0.15 ml | Subcutaneous |
| Subject | Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined | Vaccine | 0.5 ml | Subcutaneous |