NCT00119080

Brief Summary

The purpose of this study is to determine whether the new meningococcal conjugate vaccine (MCV4) can reduce asymptomatic carriage of meningococcal bacteria, and thus decrease the transmission of these bacteria in the population.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2005

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

March 19, 2007

Status Verified

March 1, 2007

First QC Date

July 7, 2005

Last Update Submit

March 16, 2007

Conditions

Meningitis

Keywords

Meningococcal carriageConjugate vaccine

Outcome Measures

Primary Outcomes (1)

  • The prevalence of asymptomatic nasopharyngeal carriage of meningococci serogroup Y in vaccinated and unvaccinated individuals

Secondary Outcomes (2)

  • The overall prevalence of asymptomatic nasopharyngeal carriage of meningococci in vaccinated and unvaccinated individuals

  • the baseline prevalence of asymptomatic nasopharyngeal carriage of meningococci

Interventions

meningococcal conjugate vaccine (Menactra)BIOLOGICAL

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • High school students (grades 9-12) enrolled in participating schools

You may not qualify if:

  • Contraindications to vaccine administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Meningitis

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neuroinflammatory DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Bacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Eric Stern, MD

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

July 7, 2005

First Posted

July 13, 2005

Study Start

August 1, 2006

Study Completion

May 1, 2007

Last Updated

March 19, 2007

Record last verified: 2007-03