title: Safety Monitoring in Group A Meningococcal Conjugate Vaccine Trials: Description, Challenges, and Lessons.
abstract: BACKGROUND
  The determination of the safety profile of any vaccine is critical to its widespread use in any population. In addition, the application of international guidelines to fit local context could be a challenging but important step toward obtaining quality safety data.
  
  
  METHODS
  In clinical studies of PsA-TT (MenAfriVac), safety was monitored immediately after vaccination, at 4-7 days for postimmunization local and systemic reactions, within 28 days for adverse events, and throughout the duration of study for serious adverse events. Initial and ongoing training of sites' staff were undertaken during the studies, and a data and safety monitoring board reviewed all the data during and after the studies.
  
  
  RESULTS
  The safety of PsA-TT was evaluated according to international standards despite obvious challenges in remote areas where these studies were conducted. These challenges included the need for uniformity of methods, timely reporting in the context of frequent communication problems, occurrence of seasonal diseases such as malaria and rotavirus diarrhea, and healthcare systems that required improvement.
  
  
  CONCLUSIONS
  The trials of PsA-TT highlighted the value of a robust vaccine development plan and design so that lessons learned in initial studies were incorporated into the subsequent ones, initial training and periodic retraining, strict monitoring of all procedures, and continuous channel of communication with all stakeholders that enabled the application of international requirements to local settings, with high quality of data.
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Godwin C
authors.initials: GC
authors.lastname: Enwere
authors.affiliation: DiagnoSearch Laboratories, Mumbai.
authors.forename: Gandhali
authors.initials: G
authors.lastname: Paranjape
authors.affiliation: Serum Institute of India, Ltd, Pune.
authors.forename: Prasad S
authors.initials: PS
authors.lastname: Kulkarni
authors.affiliation: DiagnoSearch Laboratories, Mumbai.
authors.forename: Manisha
authors.initials: M
authors.lastname: Ginde
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.
authors.forename: Simonetta
authors.initials: S
authors.lastname: Viviani
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Julie
authors.initials: J
authors.lastname: Chaumont
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: Marie-Francoise
authors.initials: MF
authors.lastname: Makadi
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Karen
authors.initials: K
authors.lastname: Ivinson
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Elisa
authors.initials: E
authors.lastname: Marchetti
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Herve
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Kim
authors.initials: K
authors.lastname: Kertson
authors.affiliation: Serum Institute of India, Ltd, Pune.
authors.forename: F Marc
authors.initials: FM
authors.lastname: LaForce
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: D002986:Clinical Trials as Topic; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D006801:Humans; D022401:Meningococcal Vaccines / Q000008:administration & dosage*
chemical_list: C573970:MenAfriVac; D022401:Meningococcal Vaccines
keywords: MenAfriVac; effective communication; safety monitoring and reporting; uniform methods