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

Tapia, Milagritos D. ; Sow, Samba O. ; Haidara, Fadima Cheick ; Diallo, Fatoumata ; Doumbia, Moussa ; Enwere, Godwin C. ; Paranjape, Gandhali ; Hervé, Jacques ; Bouma, Enricke ; Parulekar, Varsha ; Martellet, Lionel ; Chaumont, Julie ; Plikaytis, Brian D. ; Tang, Yuxiao ; Kulkarni, Prasad S. ; Hartmann, Katharina ; Preziosi, Marie-Pierre

In: Clinical Infectious Diseases, 2015, vol. 61, p. S507-S513

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    Titre
    • A Phase 3, Double-Blind, Randomized, Active Controlled Study to Evaluate the Safety of MenAfriVac in Healthy Malians
    Auteur
    • Tapia, Milagritos D.. Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore
    • Sow, Samba O.. Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali
    • Haidara, Fadima Cheick. Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali
    • Diallo, Fatoumata. Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali
    • Doumbia, Moussa. Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali
    • Enwere, Godwin C.. Meningitis Vaccine Project, PATH, Ferney-Voltaire, France
    • Paranjape, Gandhali. DiagnoSearch Life Sciences, Mumbai, India
    • Hervé, Jacques. Meningitis Vaccine Project, PATH, Ferney-Voltaire, France
    • Bouma, Enricke. Meningitis Vaccine Project, PATH, Ferney-Voltaire, France
    • Parulekar, Varsha. DiagnoSearch Life Sciences, Mumbai, India
    • Martellet, Lionel. Meningitis Vaccine Project, PATH, Ferney-Voltaire, France
    • Chaumont, Julie. Meningitis Vaccine Project, PATH, Ferney-Voltaire, France
    • Plikaytis, Brian D.. Centers for Disease Control and Prevention, Atlanta, Georgia
    • Tang, Yuxiao. Meningitis Vaccine Project, PATH, Seattle, Washington
    • Kulkarni, Prasad S.. Serum Institute of India Ltd, Pune
    • Hartmann, Katharina. Department of Pharmacovigilance and Pharmacoepidemiology, Eidgenössische Technische Hochschule, Zürich
    • Preziosi, Marie-Pierre. Meningitis Vaccine Project, PATH, Ferney-Voltaire, France
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • Clinical Infectious Diseases, 2015, vol. 61, p. S507-S513. Oxford University Press
    Autre version électronique
    Identifiant OAI-PMH
    • oai:doc.rero.ch:301813
    Summary
    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. Clinical Trials Registration. PACTR ATMR201003000191317