MedTrace Logo

Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®

NCT00850603 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2016-04-14

Study results available
· View outcomes & findings →

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2003-05-31
Completion
2004-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00850603 on ClinicalTrials.gov