title: A Phase 3, Double-Blind, Randomized, Active Controlled Study to Evaluate the Safety of MenAfriVac in Healthy Malians.
abstract: BACKGROUND
  A safe, affordable, and highly immunogenic meningococcal A conjugate vaccine (PsA-TT, MenAfriVac) was developed to control epidemic group A meningitis in Africa. Documentation of the safety specifications of the PsA-TT vaccine was warranted, with sufficient exposure to detect potential rare vaccine-related adverse reactions.
  
  
  METHODS
  This phase 3, double-blind, randomized, active controlled clinical study was designed to evaluate the safety--primarily vaccine-related serious adverse events (SAEs)--up to 3 months after administration of a single dose of the PsA-TT vaccine to subjects aged 1-29 years in Mali. Safety outcomes were also compared to those following a single dose of a licensed meningococcal ACWY polysaccharide vaccine (PsACWY).
  
  
  RESULTS
  No vaccine-related SAEs occurred during the 3 months of follow-up of 4004 subjects vaccinated with a single dose of PsA-TT. When compared to PsACWY (1996 subjects), tenderness at the injection site appeared to be more frequent in the PsA-TT group. However, rates of local induration, systemic reactions, adverse events (AEs), and SAEs were similar in both groups, and unsolicited AEs and SAEs were all unrelated to the study vaccines.
  
  
  CONCLUSIONS
  The study confirmed on a large scale the excellent safety profile of a single dose of PsA-TT when administered to its entire target population of 1-29 years of age.
  
  
  BACKGROUND
  PACTR ATMR201003000191317.
authors.affiliation: Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.
authors.forename: Milagritos D
authors.initials: MD
authors.lastname: Tapia
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: Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali.
authors.forename: Fadima Cheick
authors.initials: FC
authors.lastname: Haidara
authors.affiliation: Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali.
authors.forename: Fatoumata
authors.initials: F
authors.lastname: Diallo
authors.affiliation: Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali.
authors.forename: Moussa
authors.initials: M
authors.lastname: Doumbia
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Godwin C
authors.initials: GC
authors.lastname: Enwere
authors.affiliation: DiagnoSearch Life Sciences, Mumbai, India.
authors.forename: Gandhali
authors.initials: G
authors.lastname: Paranjape
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Hervé
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Enricke
authors.initials: E
authors.lastname: Bouma
authors.affiliation: DiagnoSearch Life Sciences, Mumbai, India.
authors.forename: Varsha
authors.initials: V
authors.lastname: Parulekar
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Martellet
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Julie
authors.initials: J
authors.lastname: Chaumont
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Brian D
authors.initials: BD
authors.lastname: Plikaytis
authors.affiliation: Meningitis Vaccine Project, PATH, Seattle, Washington.
authors.forename: Yuxiao
authors.initials: Y
authors.lastname: Tang
authors.affiliation: Serum Institute of India Ltd, Pune.
authors.forename: Prasad S
authors.initials: PS
authors.lastname: Kulkarni
authors.affiliation: Department of Pharmacovigilance and Pharmacoepidemiology, Eidgenössische Technische Hochschule, Zürich.
authors.forename: Katharina
authors.initials: K
authors.lastname: Hartmann
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France Meningitis Vaccine Project, Department of Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland.
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: Preziosi
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008302:Mali / Q000453:epidemiology; D008585:Meningitis, Meningococcal / Q000453:epidemiology / Q000382:microbiology / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D038381:Neisseria meningitidis, Serogroup A / Q000276:immunology; D055815:Young Adult
chemical_list: C573970:MenAfriVac; D022401:Meningococcal Vaccines
keywords: Africa; MenAfriVac; active control; randomized clinical trial; vaccine safety