Study Stopped
No cases on NmA meningitis were recorded following vaccination with MenAfriVac
A Case-control Study of the Efficacy of a New Serogroup A Meningococcal Conjugate Vaccine (MenAfriVac) in Mali and Niger
VES
Sponsor study identifier
observational
0
2 countries
2
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Major epidemics of meningococcal meningitis occur in countries of the African Sahel and sub-Sahel every few years. Most of these epidemics are caused by meningococci belonging to serogroup A. Until recently there has been no serogroup A conjugate vaccine available to prevent epidemics in Africa because none of the major pharmaceutical companies wanted to develop such a vaccine for commercial reasons. For this reason a public private partnership was established in 2001, the Meningitis Vaccine Project (MVP), with support from the Bill and Melinda Gates Foundation, to develop an affordable new serogroup A meningococcal conjugate vaccine for Africa. The new vaccine, MenAfriVac™, received WHO pre-qualification in 2010 and mass campaigns started in Burkina Faso, Mali and Niger in 2010. It is expected that full coverage through mass vaccination campaigns will be achieved by the end of 2011 in these three countries. A case-control study will be conducted in Mali and Niger during the epidemic seasons of 2012 and 2013 to assess the efficacy of MenAfriVac™.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2011
Actual (reported)February 24, 2011
Actual (reported)February 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
serogroup A meningococci disease
3 years
Cases of serogroup A meningococcal disease
Healthy members of the community controls matched with cases for age, sex and place of residence
Patients admitted to the hospital with an acute illness other than meningitis or septicemia
Cases: Patients with serogroup A meningococcal meningitis Hospital controls: Patients admitted to the same hospital/health facility as the case with an acute illness other than meningitis or septicemia. Community controls:Healthy individuals recruited from the same community as the case
Center for Vaccine Development
Bamako, Bamako, Mali
Centre de Recherche Médicale et Sanitaire, CERMES
Niamey, Niamey, Niger
Sera samples will be separated from 5 ml blood sample obtained from cases and controls.
Brian Greenwood, MD
London School of Hygiene and Tropical Medicine
James Stuart, MD
London School of Hygiene and Tropical Medicine
0 participants (actual enrollment reported by the registry).
First Submitted
February 8, 2011
First Posted
February 24, 2011
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Dose-finding and Safety of 2 Intradermal MEN-ACYW135-conjugate Vaccines
Contact the study team to confirm eligibility.
Primary Completion
May 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 20, 2013
Record last verified: 2013-02
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Source: ClinicalTrials.gov.
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