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Safety Monitoring in Group A Meningococcal Conjugate Vaccine Trials: Description, Challenges, and Lessons.

Autor: Enwere GC; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Paranjape G; DiagnoSearch Laboratories, Mumbai., Kulkarni PS; Serum Institute of India, Ltd, Pune., Ginde M; DiagnoSearch Laboratories, Mumbai., Hartmann K; Department of Pharmacovigilance and Pharmacoepidemiology, Eidgenössische Technische Hochschule, Zürich., Viviani S; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Chaumont J; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Martellet L; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Makadi MF; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Ivinson K; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Marchetti E; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Herve J; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Kertson K; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., LaForce FM; Serum Institute of India, Ltd, Pune., Preziosi MP; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France Meningitis Vaccine Project, Department of Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland.

Publikováno v: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2015 Nov 15; Vol. 61 Suppl 5, pp. S501-6.

A Phase 3, Double-Blind, Randomized, Active Controlled Study to Evaluate the Safety of MenAfriVac in Healthy Malians.

Autor: Tapia MD; Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore., Sow SO; Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali., Haidara FC; Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali., Diallo F; Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali., Doumbia M; Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali., Enwere GC; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Paranjape G; DiagnoSearch Life Sciences, Mumbai, India., Hervé J; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Bouma E; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Parulekar V; DiagnoSearch Life Sciences, Mumbai, India., Martellet L; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Chaumont J; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Plikaytis BD; Centers for Disease Control and Prevention, Atlanta, Georgia., Tang Y; Meningitis Vaccine Project, PATH, Seattle, Washington., Kulkarni PS; Serum Institute of India Ltd, Pune., Hartmann K; Department of Pharmacovigilance and Pharmacoepidemiology, Eidgenössische Technische Hochschule, Zürich., Preziosi MP; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France Meningitis Vaccine Project, Department of Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland.

Publikováno v: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2015 Nov 15; Vol. 61 Suppl 5, pp. S507-13.

Antibody Persistence at 1 and 4 Years Following a Single Dose of MenAfriVac or Quadrivalent Polysaccharide Vaccine in Healthy Subjects Aged 2-29 Years.

Autor: Diallo A; Institut de Recherche pour le Développement, Niakhar, Sénégal., Sow SO; Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali., Idoko OT; Medical Research Council Laboratories, Basse, The Gambia., Hirve S; Shirdi Sai Baba Hospital, Vadu/King Edward Memorial Hospital and Research Centre, Pune, India., Findlow H; Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, United Kingdom., Preziosi MP; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France Meningitis Vaccine Project, Department of Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland., Elie C; Centers for Disease Control and Prevention, Atlanta, Georgia., Kulkarni PS; Serum Institute of India, Ltd, Pune., Parulekar V; DiagnoSearch Life Sciences, Mumbai, India., Diarra B; Institut de Recherche pour le Développement, Niakhar, Sénégal., Cheick Haidara F; Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali., Diallo F; Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali., Tapia M; Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore., Akinsola AK; Medical Research Council Laboratories, Basse, The Gambia., Adegbola RA; GlaxoSmithKline Vaccines, Wavre, Belgium., Bavdekar A; Shirdi Sai Baba Hospital, Vadu/King Edward Memorial Hospital and Research Centre, Pune, India., Juvekar S; Shirdi Sai Baba Hospital, Vadu/King Edward Memorial Hospital and Research Centre, Pune, India., Chaumont J; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Martellet L; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Marchetti E; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., LaForce MF; Serum Institute of India, Ltd, Pune., Plikaytis BD; Centers for Disease Control and Prevention, Atlanta, Georgia., Enwere GC; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France., Tang Y; Meningitis Vaccine Project, PATH, Seattle, Washington., Borrow R; Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, United Kingdom., Carlone G; Centers for Disease Control and Prevention, Atlanta, Georgia., Viviani S; Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.

Publikováno v: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2015 Nov 15; Vol. 61 Suppl 5, pp. S521-30.