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Fractional Dose Tetravalent A, C, Y, W135 Meningococcal Polysaccharide Vaccine

NCT00271479 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2006-12-22

No results posted yet for this study

Summary

Hypothesis:

Lower doses of each A/C/Y/W135 component of the meningococcal polysaccharide vaccine could confer a similar functional immunogenic response as the dose of 50 μg currently being used, and subsequently be equally protective.

The purpose of this study is to evaluate the use of fractional dose tetravalent meningococcal polysaccharide vaccine to control outbreak especially caused by N. meningitidis serogroup W135

Primary Objectives:

* To measure the immunogenicity of a dose corresponding to one fifth of the amount of the licensed meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 10 μg for each component; and
* To measure the immunogenicity of a dose corresponding to one tenth of the licensed meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 5 μg for each component.

Conditions

  • Infections, Meningococcal
  • Meningitis, Meningococcic

Interventions

BIOLOGICAL

A, C, Y, W135 meningococcal polysaccharide vaccine

Sponsors & Collaborators

  • Norwegian Institute of Public Health

    collaborator OTHER_GOV

  • University of Oslo

    collaborator OTHER

  • Medecins Sans Frontieres, Netherlands

    collaborator OTHER

  • Epicentre

    lead OTHER

Principal Investigators

  • Philippe J Guerin, MD, MPH, PhD · Epicentre

  • Dominique A Caugant, PhD · Norwegian Institute of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-06-30
Completion
2006-11-30

Countries

  • Norway
  • Uganda

Study Locations

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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 NCT00271479 on ClinicalTrials.gov