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Clin Infect Dis. 2015 Nov 15;61 Suppl 5:S493-500. doi: 10.1093/cid/civ497.

Active Surveillance for Adverse Events After a Mass Vaccination Campaign With a Group A Meningococcal Conjugate Vaccine (PsA-TT) in Mali.

Author information

1
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
2
Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali.
3
Emory Vaccine Center and Rollins School of Public Health, Emory University, Atlanta, Georgia.
4
Institut supérieur des sciences de la Santé, Université Polytechnique de Bobo-Dioulasso, Burkina Faso.
5
Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland.
6
World Health Organization, Mali Country Office, Bamako, Mali.
7
Centers for Disease Control and Prevention, Atlanta, Georgia.

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.

KEYWORDS:

MenAfriVac; PsA-TT; meningitis belt; meningococcal vaccine; vaccine safety

PMID:
26553680
PMCID:
PMC4639483
DOI:
10.1093/cid/civ497
[Indexed for MEDLINE]
Free PMC Article

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