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Dose Comparison Study of Menactra® in US Children

NCT00700635 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2016-04-14

Study results available
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Summary

To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children.

Primary Objective:

To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.

Conditions

  • Meningitis
  • Meningococcal Infection
  • Neisseria Meningitidis

Interventions

BIOLOGICAL

Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate

0.5 mL, 2 doses Intramuscular

BIOLOGICAL

Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate

0.5 mL, 2 doses Intramuscular

BIOLOGICAL

Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate

0.5 mL, 1 dose Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-05-31
Completion
2009-10-31

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 NCT00700635 on ClinicalTrials.gov