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Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine

NCT00772070 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2014-02-14

Study results available
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Summary

This study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in children who were vaccinated with one dose of TetraMenD at least 18 months earlier.

Primary Objective:

To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine to those responses in participants who received the same reduced dose of Menomune® but had not previously received any meningococcal vaccine.

Conditions

  • Meningitis
  • Meningococcemia
  • Neisseria Meningitidis

Interventions

BIOLOGICAL

A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)

0.05 mL, Subcutaneous

BIOLOGICAL

A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)

0.05 mL, Subcutaneous

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2003-08-31
Completion
2004-05-31

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 NCT00772070 on ClinicalTrials.gov