title: Active Surveillance for Adverse Events After a Mass Vaccination Campaign With a Group A Meningococcal Conjugate Vaccine (PsA-TT) in Mali.
abstract: BACKGROUND
  The monovalent meningococcal A conjugate vaccine (PsA-TT, MenAfriVac) was developed for use in the "meningitis belt" of sub-Saharan Africa. Mali was 1 of 3 countries selected for early introduction. As this is a new vaccine, postlicensure surveillance is particularly important to identify and characterize possible safety issues.
  
  
  METHODS
  The national vaccination campaign was phased from September 2010 to November 2011. We conducted postlicensure safety surveillance for PsA-TT in 40 government clinics from southern Mali serving approximately 400 000 people 1-29 years of age. We conducted analyses with individual-level data and population-level data, and we calculated rates of adverse events using the conditional exact test, a modified vaccine cohort risk interval method, and a modified self-controlled case series method for each outcome of interest, including 18 prespecified adverse events and 18 syndromic categories.
  
  
  RESULTS
  An increased rate of clinic visits for fever within 3 days after vaccination was found using multiple methods for all age groups. Although other signals were found with some methods, complete assessment of all other prespecified outcomes and syndromic categories did not reveal that PsA-TT was consistently associated with any other health problem.
  
  
  CONCLUSIONS
  No new safety concerns were identified in this study. These results are consistent with prelicensure data and other studies indicating that PsA-TT is safe. The approach presented could serve as a model for future active postlicensure vaccine safety monitoring associated with large-scale immunization campaigns in low-income countries.
authors.affiliation: Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Kirsten S
authors.initials: KS
authors.lastname: Vannice
authors.affiliation: Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali.
authors.forename: Modibo
authors.initials: M
authors.lastname: Keita
authors.affiliation: Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali.
authors.forename: Samba O
authors.initials: SO
authors.lastname: Sow
authors.affiliation: Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Anna P
authors.initials: AP
authors.lastname: Durbin
authors.affiliation: Emory Vaccine Center and Rollins School of Public Health, Emory University, Atlanta, Georgia.
authors.forename: Saad B
authors.initials: SB
authors.lastname: Omer
authors.affiliation: Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Lawrence H
authors.initials: LH
authors.lastname: Moulton
authors.affiliation: Institut supérieur des sciences de la Santé, Université Polytechnique de Bobo-Dioulasso, Burkina Faso.
authors.forename: Téné M
authors.initials: TM
authors.lastname: Yaméogo
authors.affiliation: Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland.
authors.forename: Patrick L F
authors.initials: PL
authors.lastname: Zuber
authors.affiliation: Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali.
authors.forename: Uma
authors.initials: U
authors.lastname: Onwuchekwa
authors.affiliation: World Health Organization, Mali Country Office, Bamako, Mali.
authors.forename: Massambou
authors.initials: M
authors.lastname: Sacko
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Fabien V K
authors.initials: FV
authors.lastname: Diomandé
authors.affiliation: Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Neal A
authors.initials: NA
authors.lastname: Halsey
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D006801:Humans; D015994:Incidence; D007223:Infant; D008302:Mali / Q000453:epidemiology; D032541:Mass Vaccination; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D055815:Young Adult
chemical_list: C573970:MenAfriVac; D022401:Meningococcal Vaccines
keywords: MenAfriVac; PsA-TT; meningitis belt; meningococcal vaccine; vaccine safety