- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00119080
Effect of Meningococcal Conjugate Vaccine on Meningococcal Carriage
Evaluation of the Effect of Tetravalent (A, C, Y, W-135) Meningococcal Conjugate Vaccine on Serogroup-Specific Carriage of Neisseria Meningitidis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- High school students (grades 9-12) enrolled in participating schools
Exclusion Criteria:
- Contraindications to vaccine administration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
The prevalence of asymptomatic nasopharyngeal carriage of meningococci serogroup Y in vaccinated and unvaccinated individuals
|
Secondary Outcome Measures
Outcome Measure |
---|
The overall prevalence of asymptomatic nasopharyngeal carriage of meningococci in vaccinated and unvaccinated individuals
|
the baseline prevalence of asymptomatic nasopharyngeal carriage of meningococci
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Eric Stern, MD, Centers for Disease Control and Prevention
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCID-4591
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Meningitis
-
Prof. Elizabeth MillerNovartis VaccinesCompletedMeningococcal Meningitis, Serogroup A | Meningococcal Meningitis, Serogroup B | Meningococcal Meningitis, Serogroup C | Meningococcal Meningitis, Serogroup Y | Meningococcal Meningitis, Serogroup WUnited Kingdom
-
University Hospital, Strasbourg, FranceCompleted
-
Assiut UniversityUnknown
-
University Medical Centre LjubljanaHarvard University; University of Ljubljana School of Medicine, Slovenia; Slovenian...Unknown
-
University of MinnesotaNational Institute of Neurological Disorders and Stroke (NINDS); Medical Research... and other collaboratorsCompletedCryptococcal Meningitis | Fungal MeningitisUganda
-
Rambam Health Care CampusWithdrawnGram Negative Meningitis | Post Traumatic Bacterial MeningitisIsrael
-
Charite University, Berlin, GermanyRecruitingBacterial Meningitis | Implant Infection | Fungal MeningitisGermany
-
Brigham and Women's HospitalActive, not recruitingPreventive Immunization; MeningitisUnited States
-
Matinas BioPharma Nanotechnologies, Inc.University of MinnesotaNot yet recruitingCryptococcal Meningitis
Clinical Trials on meningococcal conjugate vaccine (Menactra)
-
Sanofi Pasteur, a Sanofi CompanyCompletedMeningitis | Meningococcal InfectionCanada
-
Sanofi Pasteur, a Sanofi CompanyCompletedMeasles | Rubella | Mumps | Varicella | Meningococcal MeningitisUnited States
-
Sanofi Pasteur, a Sanofi CompanyCompletedMeningitis | Meningococcal InfectionUnited States
-
Sanofi Pasteur, a Sanofi CompanyCompletedMeningitis | Meningococcal Infection | Neisseria MeningitidisUnited States
-
Sanofi Pasteur, a Sanofi CompanyCompletedMeningitis | Meningococcal InfectionUnited States
-
SanofiCompletedMeningitis | Meningococcal InfectionIndia
-
Sanofi Pasteur, a Sanofi CompanyCompletedMeningitis | Meningococcal DiseasePhilippines
-
Sanofi Pasteur, a Sanofi CompanyCompletedMeningitis | MeningococcemiaSaudi Arabia
-
Sanofi Pasteur, a Sanofi CompanyCompletedMeningitis | Meningococcal InfectionUnited States
-
Sanofi Pasteur, a Sanofi CompanyCompletedMeningitis | MeningococcemiaUnited States