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

References

• WHO. Immunization safety surveillance guidelines for immunization programme managers on surveillance of adverse events following immunization 2nded. Manila, World Health Organization Western pacific region; Manila, 2013.
   Google Scholar
• Vaccine development, testing, and regulation. [ accessed 2015 Feb 28] http://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation.
   Google Scholar
• Abdelnour A, Silas PE, Lamas MRV, Aragón CFG, Chiu N-C, Chiu C-H, Acuña TH, Castrejón TDL, Izu A, Odrljin T, et al. Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3 b controlled study in healthy infants. Vaccine. 2014;32(8):965–72. doi:10.1016/j.vaccine.2013.12.034.
   PubMed Web of Science ®Google Scholar
• Iskander JK, Miller ER, Chen RT. The role of the Vaccine Adverse Event Reporting system (VAERS) in monitoring vaccine safety. Pediatr Ann. 2004 Sep;33(9):599–606. doi:10.3928/0090-4481-20040901-11.
   PubMed Web of Science ®Google Scholar
• WHO, Policy Perspectives on Medicines. Pharmacovigilance: ensuring the safe use of medicines. World Health Organization; Geneva, 2004.
   Google Scholar
• Alicino C, Merlano C, Zappettini S, Schiaffino S, Della Luna G, Accardo C, Gasparini R, Durando P, Icardi G. Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety. Hum Vaccin Immunother. 2014;7:e34360.
   Google Scholar
• McNeil MM, Li R, Pickering S, Real TM, Smith PJ, Pemberton MR. Who is unlikely to report adverse events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS)? Vaccine. 2013 May;31(24):2673–79. doi:10.1016/j.vaccine.2013.04.009.
   PubMed Web of Science ®Google Scholar
• Monteiro SA, Takano OA, Waldman EA. Evaluation of the Brazilian surveillance system for adverse events following vaccination. Rev Bras Epidemiol. 2011 Sep;14(3):361–71.
   PubMedGoogle Scholar
• Muehlhans S, Richard G, Ali M, Codarini G, Elemuwa C, Khamesipour A, Maurer W, Mworozi E, Kochhar S, Rundblad G, et al. Safety reporting in developing country vaccine clinical trials-a systematic review. Vaccine. 2012 May;30(22):3255–65. doi:10.1016/j.vaccine.2012.02.059.
   PubMed Web of Science ®Google Scholar
• Breugelmans JG, Lewis RF, Agbenu E, Veit O, Jackson D, Domingo C, Böthe M, Perea W, Niedrig M, Gessner DB, et al. Adverse events following yellow fever preventive vaccination campaigns in eight African countries from 2007 to 2010. Vaccine. 2013 April;31(14, 3):1819–29. doi:10.1016/j.vaccine.2013.01.054.
   PubMed Web of Science ®Google Scholar
• Guoa B, Pagea A, Wangb H, Taylorc R, Peter M. Systematic review of reporting rates of adverse events following immunization: an international comparison of post-marketing surveillance programs with reference to China. Vaccine. 2013;31:603–17. doi:10.1016/j.vaccine.2012.11.051.
   PubMed Web of Science ®Google Scholar
• Frasch CE, Preziosi M-P, Marc LaForce F. Development of a group A meningococcal conjugate vaccine, MenAfriVacTM. Hum Vaccin Immunother. 2012 June;8(6):715–24. doi:10.4161/hv.19619.
   PubMed Web of Science ®Google Scholar
• Kshirsagar N, Murb N, Thatte U, Gogtay N, Viviani S, Préziosi M-P, Elie C, Findlow H, Carlone G, Borrow R, et al. Safety, immunogenicity, and antibody persistence of a new. Vaccine. 2007;25S:A101–A107. doi:10.1016/j.vaccine.2007.04.050.
   Web of Science ®Google Scholar
• Sow SO, Okoko BJ, Diallo A, Viviani S, Borrow R, Carlone G, Tapia M, Akinsola AK, Arduin P, Findlow H, et al. Immunogenicity and safety of a meningococcal A conjugate vaccine in Africans. N Engl J Med. 2011;364:2293–304. doi:10.1056/NEJMoa1003812.
   PubMed Web of Science ®Google Scholar
• Hirvea S, Bavdekara A, Pandita A, Juvekar S, Patil M, Preziosi M-P, Tang Y, Marchetti E, Martellet L, Findlow H, et al. Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2–10 years: a Phase II/III double-blind randomized controlled trial. Vaccine. 2012;30:6456–60. doi:10.1016/j.vaccine.2012.08.004.
   PubMed Web of Science ®Google Scholar
• WHO. Meningococcal disease in countries of the Africanmeningitis belt, 2012 emerging needs and future perspectives. Weekly Epidemiol Record 2013;12:129–36.
   Google Scholar
• Chaiboua MS, Bako H, Salisou L, Yaméogo TM, Sambo M, Kim SH, Djingarey MH, Zuber PLF, Perea WA, Pezzoli L. Monitoring adverse events following immunization with a new conjugate vaccine against group A meningococcus in Niger 2010. Vaccine. 2012 Sept;30:5229–34. doi:10.1016/j.vaccine.2012.06.006.
   PubMed Web of Science ®Google Scholar
• Ouandaogo CR, Yaméogo TM, Diomandé FV, Sawadogo C, Ouédraogo B, Ouédraogo-Traoré R, Pezzoli L, Djingarey MH, Mbakuliyemo N, Zuber PLF. Adverse events following immunization during mass vaccination campaigns at first introduction of a meningococcal A conjugate vaccine in Burkina Faso, 2010. Vaccine. 2012;30(suppl 2):B46–51. doi:10.1016/j.vaccine.2011.12.112.
   PubMed Web of Science ®Google Scholar
• Ankrah DNA, Darko DM, Sabblah G, Mantel-Teeuwisse A, Leufkens HMG. Reporting of adverse events following immunizations in Ghana - Using disproportionality analysis reporting ratios. Hum Vaccin Immunother. 2018;14:172–78. doi:10.1080/21645515.2017.1384105.
   PubMed Web of Science ®Google Scholar
• WHO. Meeting of the global advisory committee on vaccine safety, june 2011. Weekly Epidemiol Record. 2011;86(30):321–24.
   PubMedGoogle Scholar
• WHO. Review of safety profile on meningococcalA. Weekly Epidemiol Record. 2010;5(85):29–36.
   Google Scholar
• Ateudjieu J, Stoll B, Nguefack-Tsague G, Tchangou C, Genton B. Vaccines safety; effect of supervision or SMS on reporting rates of adverse events following immunization (AEFI) with meningitis vaccine (MenAfriVac™): A randomized controlled trial. Vaccine. 2014 Sep 29;32(43):5662–68. doi:10.1016/j.vaccine.2014.08.012.
   PubMed Web of Science ®Google Scholar
• Vannice KS, Keita M, Sow SO, Durbin AP, Omer SB, Moulton LH, Yaméogo TM, Zuber PLF, Onwuchekwa U, Sacko M, et al. Active surveillance for adverse events after a mass vaccination campaign with a group A meningococcal conjugate vaccine (PsA-TT) in Mali. Clin Infect Dis. 2015;61(S5):S493–S500. doi:10.1093/cid/civ497.
   PubMedGoogle Scholar
• Higgins JPT, Altman DG, Gøtzsche PC, Juni P, Moher D, Oxman AD, Savovic J, Schulz KF, Weeks L, Sterne JAC. Research methods & reporting: the cochrane collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928. doi:10.1136/bmj.d5928.
   PubMed Web of Science ®Google Scholar
• Steffen C, Tokplonou E, Jaillard P, Dia R, Alladji MNB, Gessner B. A field based evaluation of adverse events following MenAfriVac®vaccine delivered in a controlled temperature chain (CTC) approach in Benin. Pan Afr Med J. 2014;18:344. doi:10.11604/pamj.2014.18.226.4800.
   PubMedGoogle Scholar
• Meningitis vaccine project. Meningitis vaccine project. Meningitis vaccine project. [ Accessed 2015 Mar 07]. http://www.meningvax.org/.
   Google Scholar
• Bonhoeffer J, Kohl K, Chen R, Duclos P, Heijbel H, Heininger U, Jefferson T, Loupi E. The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI). Vaccine. 2002;21:298–302. doi:10.1016/s0264-410x(02)00449-8.
   PubMed Web of Science ®Google Scholar
• Nzolo D, Ntetani Aloni M, Mpiempie Ngamasata T, Mvete Luemba B, Bazundama Marfeza S, Bothale Ekila M, Ndosimao Nsibu C, Lutete Tona N. Adverse events following immunization with oral poliovirus in Kinshasa, Democratic Republic of Congo: preliminary results. Pathog Glob Health. 2013 Oct;107(7):381–84. doi:10.1179/2047773213Y.0000000113.
   PubMed Web of Science ®Google Scholar
• Frenck RW Jr., Gurtman A, Rubino J, Smith W, van Cleeff M, Jayawardene D, Giardina PC, Emini EA, Gruber WC, Scott DA, et al. Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. Clin Vaccine Immunol. 2012;19(8):1296–303. doi:10.1128/CVI.00176-12.
   PubMed Web of Science ®Google Scholar
• Yeh SH, Gurtman A, Hurley DC, Block SL, Schwartz RH, Patterson S, Jansen KU, Love J, Gruber WC, Emini EA, et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010;126:3. doi:10.1542/peds.2009-3027.
   Web of Science ®Google Scholar
• Schwarza FT, Flamaing R, Rümke HC, Penzes J, Juergens C, Wenz A, Jayawardene D, Giardina P, Emini EA, Gruber WC, et al. 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. Vaccine. 2011;29:5195–202. doi:10.1016/j.vaccine.2011.05.031.
   PubMed Web of Science ®Google Scholar
• Bryant KA, Stan L, Baker SA, Gruber WC, Scott DA. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. Pediatrics. 2010;125:5. doi:10.1542/peds.2009-1405.
   Web of Science ®Google Scholar
• Durando P, Rosselli R, Cremonesi I. Safety and tolerability of 13-valent pneumococcal conjugate vaccine in the elderly. Hum Vaccin Immunother. 2015;11(1):172–77. doi:10.4161/hv.34420.
   PubMed Web of Science ®Google Scholar
• Izurieta HS, Zuber P, Bonhoeffer J, Chen RT, Sankohg O, Laserson KF, Sturkenboom M, Loucq C, Weibel D, Dodd C, et al. Roadmap for the international collaborative epidemiologic monitoring of safety and effectiveness of new high priority. Vaccines. 2013;31:3623–27.
   PubMed Web of Science ®Google Scholar
• Guillard-Maure EV, Black S, Black S, Perez-Vilar S, Castro JL, Bravo-Alcántara P, Molina-León HF, Weibel D, Sturkenboom M, Zuber PLF. 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. Vaccine. 2018 Jan 8;36(3):355–62. doi:10.1016/j.vaccine.2017.07.085.
   PubMed Web of Science ®Google Scholar
• Perez-Vilar S, Weibel D, Sturkenboom M, Black S, Maure C, Castro JL, Bravo-Alcántara P, Dodd CN, Romio SA, de Ridder M, Nakato S, Molina-León HF, Elango V, Zuber PLF. WHO Global Vaccine Safety-Multi Country Collaboration. Enhancing global vaccine pharmacovigilance: proof-of-concept study on aseptic meningitis and immune thrombocytopenic purpura following measles-mumps containing vaccination. Vaccine. 2018;36(3):347–54. doi:10.1016/j.vaccine.2017.05.012.
   PubMed Web of Science ®Google Scholar
• WHO. Immunization safety surveillance: guidelines for managers of immunization programmes on reporting and investigating adverse events following immunization. Manila: World Health Organization Western Pacific Regional Office; Manila, 1999.
   Google Scholar