Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119080
Status:
COMPLETED
Last Update Posted:
2007-03-19
First Post:
2005-07-07
Brief Title:
Effect of Meningococcal Conjugate Vaccine on Meningococcal Carriage
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Evaluation of the Effect of Tetravalent A C Y W-135 Meningococcal Conjugate Vaccine on Serogroup-Specific Carriage of Neisseria Meningitidis
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2000 students in each group will be needed for the study Anticipating 35 refusal rate and 25 loss to follow-up approximately 4200 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
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 2000 students in each group will be needed for the study Anticipating 35 refusal rate and 25 loss to follow-up approximately 4200 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None