Literature DB >> 31403358

Safety profile of the meningococcal conjugate vaccine (Menafrivac™) in clinical trials and vaccination campaigns: a review of published studies.

Jerome Ateudjieu1,2,3, Beat Stoll4, Anne Cecile Bisseck3,5, Ayok M Tembei6, Blaise Genton2,7.   

Abstract

The study aimed to assess the capacity of AEFI surveillance during vaccination campaigns with the new conjugate meningitis vaccine (MenAfrivac). A systematic review of studies on MenAfrivac™ published in English during 2001-2016 was done.AEFIs incidence (I) was estimated and compared between MenAfrivac™ clinical trials and immunization campaigns using incidence difference (Id). Nine studies were included with an overall local AEFI I of 11,496/100,000 doses administered per week in clinical trials and 0.72/100,000 doses in immunization campaigns. An Id of 11,497.92 [11,497.91-11,497.93] and 17,243.20 [17,241.80-17,245.90] per 100,000 doses administered per week for overall local and systemic AEFI, respectively, were observed with highest from clinical trials. The incidence of AEFIs after MenAfrivac™ vaccination was far lower in campaigns than in clinical trial studies. Current capacity of AEFI surveillance during vaccination campaigns requires extensive re-assessment of its structure and capacity.

Entities:  

Keywords:  AEFI surveillance; MenAfrivac™ safety; clinical trials; immunization campaigns

Year:  2019        PMID： 31403358      PMCID： PMC7482715          DOI： 10.1080/21645515.2019.1652041

Source DB:  PubMed          Journal:  Hum Vaccin Immunother        ISSN： 2164-5515            Impact factor:   3.452


  31 in total

1.  A randomized, double-blind trial to evaluate immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given concomitantly with trivalent influenza vaccine in adults aged ≥65 years.

Authors:  T F Schwarz; J Flamaing; H C Rümke; J Penzes; C Juergens; A Wenz; D Jayawardene; P Giardina; E A Emini; W C Gruber; B Schmoele-Thoma
Journal:  Vaccine       Date:  2011-05-25       Impact factor: 3.641

2.  Who is unlikely to report adverse events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS)?

Authors:  Michael M McNeil; Rongxia Li; Susanne Pickering; Theresa M Real; Philip J Smith; Michael R Pemberton
Journal:  Vaccine       Date:  2013-04-16       Impact factor: 3.641

3.  Vaccines safety; effect of supervision or SMS on reporting rates of adverse events following immunization (AEFI) with meningitis vaccine (MenAfriVac™): a randomized controlled trial.

Authors:  Jerome Ateudjieu; Beat Stoll; Georges Nguefack-Tsague; Christoph Tchangou; Blaise Genton
Journal:  Vaccine       Date:  2014-08-23       Impact factor: 3.641

4.  Adverse events following immunization with oral poliovirus in Kinshasa, Democratic Republic of Congo: preliminary results.

Authors:  Didier Nzolo; Michel Ntetani Aloni; Thérèse Mpiempie Ngamasata; Bibiche Mvete Luemba; Sandrine Bazundama Marfeza; Mathilde Bothale Ekila; Célestin Ndosimao Nsibu; Narcisse Lutete Tona
Journal:  Pathog Glob Health       Date:  2013-10       Impact factor: 2.894

5.  Adverse events following immunization during mass vaccination campaigns at first introduction of a meningococcal A conjugate vaccine in Burkina Faso, 2010.

Authors:  Claude-Roger Ouandaogo; Téné M Yaméogo; Fabien V K Diomandé; Charles Sawadogo; Bassirou Ouédraogo; Rasmata Ouédraogo-Traoré; Lorenzo Pezzoli; Mamoudou H Djingarey; Nehémie Mbakuliyemo; Patrick L F Zuber
Journal:  Vaccine       Date:  2012-01-09       Impact factor: 3.641

6.  The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI).

Authors:  Jan Bonhoeffer; Katrin Kohl; Robert Chen; Philippe Duclos; Harald Heijbel; Ulrich Heininger; Tom Jefferson; Elisabeth Loupi
Journal:  Vaccine       Date:  2002-12-13       Impact factor: 3.641

7.  Safety and tolerability of 13-valent pneumococcal conjugate vaccine in the elderly.

Authors:  Paolo Durando; Roberto Rosselli; Ilaria Cremonesi; Andrea Orsi; Erika Albanese; Ilaria Barberis; Chiara Paganino; Cecilia Trucchi; Mariano Martini; Lorenzo Marensi; Valter Turello; The Ligurian Pneumococcal Study Group; Alessandro Bregante; Roberto Cacciani; Rocco Iudici; Diego La Marca; Leonardo Pedano; Amadio Franco Petrucci; Maria Santolini; Valentina Sbisà; Monica Zacconi
Journal:  Hum Vaccin Immunother       Date:  2014-11-01       Impact factor: 3.452

8.  Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults.

Authors:  Nilima Kshirsagar; Naidu Mur; Urmila Thatte; Nithya Gogtay; Simonetta Viviani; Marie-Pierre Préziosi; Cheryl Elie; Helen Findlow; George Carlone; Ray Borrow; Varsha Parulekar; Brian Plikaytis; Prasad Kulkarni; Nathalie Imbault; F Marc LaForce
Journal:  Vaccine       Date:  2007-05-08       Impact factor: 3.641

9.  Operational lessons learned in conducting a multi-country collaboration for vaccine safety signal verification and hypothesis testing: The global vaccine safety multi country collaboration initiative.

Authors:  Christine Guillard-Maure; Varalakshmi Elango; Steven Black; Silvia Perez-Vilar; Jose Luis Castro; Pamela Bravo-Alcántara; Helvert Felipe Molina-León; Daniel Weibel; Miriam Sturkenboom; Patrick L F Zuber
Journal:  Vaccine       Date:  2017-08-02       Impact factor: 3.641

10.  Enhancing global vaccine pharmacovigilance: Proof-of-concept study on aseptic meningitis and immune thrombocytopenic purpura following measles-mumps containing vaccination.

Authors:  Silvia Perez-Vilar; Daniel Weibel; Miriam Sturkenboom; Steven Black; Christine Maure; Jose Luis Castro; Pamela Bravo-Alcántara; Caitlin N Dodd; Silvana A Romio; Maria de Ridder; Swabra Nakato; Helvert Felipe Molina-León; Varalakshmi Elango; Patrick L F Zuber
Journal:  Vaccine       Date:  2017-05-27       Impact factor: 3.641
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