Effect of Meningococcal Conjugate Vaccine on Meningococcal Carriage

Status Completed

Clinical Trial Summary

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Meningitis

Clinical Trial Details

NCT number	NCT00119080
Study type	Interventional
Source	Centers for Disease Control and Prevention
Contact
Status	Completed
Phase	Phase 4
Start date	August 2006
Completion date	May 2007

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT03445416` - Increasing Healthcare Engagement Via Routine Vaccination Among Young Black Men Who Have Sex With Men	N/A
Completed	`NCT02526394` - Pertussis and Meningitis C Concomitant Vaccination in Adolescents	Phase 4
Completed	`NCT01442675` - Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine	Phase 2
Completed	`NCT00539032` - Immunology and Safety of Menactra® in Children in Saudi Arabia	Phase 3
Terminated	`NCT00428051` - Colombia Epidemiologic Surveillance Study	N/A
Recruiting	`NCT05496673` - Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda	N/A
Completed	`NCT02003495` - Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine	Phase 3
Recruiting	`NCT00901602` - Lebanese Interhospital Pneumococcal Surveillance Program
Completed	`NCT00850603` - Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®	Phase 4
Completed	`NCT02591290` - Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects	Phase 4
Completed	`NCT03112031` - Treatment With Tamoxifen in Cryptococcal Meningitis	Phase 2
Completed	`NCT02881957` - Hypovitaminosis D in Neurocritical Patients	Phase 2/Phase 3
Completed	`NCT06334796` - Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology	Early Phase 1
Completed	`NCT03378258` - Petechiae In Children (PIC) Study: Defining A Clinical Decision Rule for The Management Of Fever and Non-Blanching Rashes In Children Including The Role Of Point Of Care Testing For Procalcitonin & Neisseria Meningitidis DNA.
Recruiting	`NCT05637645` - Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section	N/A
Completed	`NCT02841254` - Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies	N/A
Completed	`NCT02003313` - Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine	Phase 3
Recruiting	`NCT01619462` - Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children	Phase 3
Completed	`NCT01239043` - Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination	Phase 2
Completed	`NCT00495690` - Impact of Daily Zinc Supplementation to Infants Born With Low Birth Weight on Death and Severe Disease	Phase 3