CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 170 enrolled
Drug / intervention
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined +4 morebiological
Likely dose
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00850603
NCT00850603Phase 4Completed
CompareCT.gov

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

Sanofi Pasteur, a Sanofi Company·interventional·Posted Feb 25, 2009·Updated Apr 14, 2016

In Brief

A Phase 4 clinical trial evaluating Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined for Meningococcal Infections and Meningitis. Completed, enrolled 170 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Infections, Meningitis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 25, 2009
Enrollment StartOct 1, 2002
Primary CompletionMay 1, 2003
Study CompletionNov 1, 2004
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.4 years ago

Interventions

Meningococcal Polysaccharide Groups A\C\Y\W-135 Combinedbiological

0.5 mL, Subcutaneous

Meningococcal Polysaccharide Groups A\C\Y\W-135 Combinedbiological

0.1 mL, Subcutaneous

Meningococcal Polysaccharide Groups A\C\Y\W-135 Combinedbiological

0.05 mL, Intradermal

Meningococcal Polysaccharide Groups A\C\Y\W-135 Combinedbiological

0.1 mL, Intradermal

Meningococcal Polysaccharide Groups A\C\Y\W-135 Combinedbiological

0.15 mL, Intradermal