Effect of Meningococcal Conjugate Vaccine on Meningococcal Carriage

NCT ID: NCT00119080

Last Updated: 2007-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 4000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2007-05-31

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.

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.

Conditions

Meningitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

meningococcal conjugate vaccine (Menactra)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Contraindications to vaccine administration

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Georgia Department of Human Resources

OTHER_GOV

Sponsor Role: collaborator

Maryland Department of Health and Mental Hygiene

OTHER_GOV

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Principal Investigators

Eric Stern, MD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Other Identifiers

CDC-NCID-4591

Identifier Type: -

Identifier Source: org_study_id