NCT00850603

Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®

Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

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.

Conditions

• Meningococcal Infections
• Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined	0.5 mL, Subcutaneous
BIOLOGICAL	Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined	0.1 mL, Subcutaneous
BIOLOGICAL	Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined	0.05 mL, Intradermal
BIOLOGICAL	Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined	0.1 mL, Intradermal
BIOLOGICAL	Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined	0.15 mL, Intradermal

Timeline

• Start date: 2002-10-01
• Primary completion: 2003-05-01
• Completion: 2004-11-01
• First posted: 2009-02-25
• Last updated: 2016-04-14
• Results posted: 2009-04-30

Locations

1 site across 1 country: United States