Effect of Meningococcal Conjugate Vaccine on Meningococcal Carriage

This study has been completed.
Sponsor:
Collaborators:
Georgia Department of Human Resources
Maryland Department of Health and Mental Hygiene
Johns Hopkins University
University of Pittsburgh
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00119080
First received: July 7, 2005
Last updated: March 16, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Meningitis
Biological: meningococcal conjugate vaccine (Menactra)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Effect of Tetravalent (A, C, Y, W-135) Meningococcal Conjugate Vaccine on Serogroup-Specific Carriage of Neisseria Meningitidis

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • The prevalence of asymptomatic nasopharyngeal carriage of meningococci serogroup Y in vaccinated and unvaccinated individuals

Secondary Outcome Measures:
  • The overall prevalence of asymptomatic nasopharyngeal carriage of meningococci in vaccinated and unvaccinated individuals
  • the baseline prevalence of asymptomatic nasopharyngeal carriage of meningococci

Estimated Enrollment: 4000
Study Start Date: August 2006
Estimated Study Completion Date: May 2007
Detailed Description:

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.

Neisseria meningitidis is a leading cause of bacterial meningitis in the United States. A new tetravalent (A, C, Y, W-135) meningococcal conjugate vaccine ([MCV4], MenactraTM manufactured by Sanofi Pasteur Inc.) has been approved by Food and Drug Administration (FDA) in January 2005. This vaccine is recommended by ACIP for routine vaccination of young adolescents at the pre-adolescent visit (11-12 years old), adolescents at high school entry (15 years old), and college freshmen living in dormitories. Prevention of asymptomatic nasopharyngeal carriage of meningococci is important to interrupt person-to-person transmission and to induce herd immunity, when lower transmission results in lower disease rates among those people who are not vaccinated. No studies have yet been done to evaluate the impact of this new vaccine on carriage.

This is a randomized study designed to evaluate the effect of MCV4 on meningococcal carriage. Several high schools will be randomized into the intervention and control groups. Students in intervention group will receive MCV4 at the beginning of the study, students in the control group will be offered MCV4 after the study completion. Three specimens of throat secretions (similar to swabs for Strep throat) will be collected from the students enrolled in the study: before vaccination of intervention group students (at the start of the school year), 8 weeks post-vaccination, and 9 months post-vaccination (at the end of the school year). Questionnaire administered at the time of swabbing will assess potential risk factors for meningococcal carriage. Meningococcal bacteria isolated from the throat specimens will be serogrouped and molecularly typed. Approximately 2,000 students in each group will be needed for the study. Anticipating 35% refusal rate and 25% loss to follow-up, approximately 4,200 high school students will need to be approached in each group.

This study will answer an important question whether those who are vaccinated are protected not only from disease, but also from being asymptomatic carriers of meningococci. If so, those who are vaccinated will not be able to carry and transmit bacteria to unvaccinated individuals. Meningococcal conjugate vaccines may become available in the near future to other age groups, including infants and children. Determining the efficacy of MCV4 against meningococcal carriage will be important for policy decisions regarding vaccination with this and future conjugate vaccines in different age groups.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to vaccine administration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119080

Sponsors and Collaborators
Georgia Department of Human Resources
Maryland Department of Health and Mental Hygiene
Johns Hopkins University
University of Pittsburgh
Investigators
Principal Investigator: Eric Stern, MD Centers for Disease Control and Prevention
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00119080     History of Changes
Other Study ID Numbers: CDC-NCID-4591
Study First Received: July 7, 2005
Last Updated: March 16, 2007
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Meningococcal carriage
Conjugate vaccine

Additional relevant MeSH terms:
Meningitis
Central Nervous System Diseases
Central Nervous System Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on October 21, 2014