References
- Deghmane AE, Taha MK. Product review on the IMD serogroup B vaccine Bexsero®. Hum Vaccin Immunother. 2022;18(1):2020043. doi:10.1080/21645515.2021.2020043.
- Sohn W-Y, Tahrat H, Novy P, Bekkat-Berkani R. Real-world implementation of 4-component meningococcal serogroup B vaccine (4CMenB): implications for clinical practices. Expert Rev Vaccines. 2022;21(3):325–13. doi:10.1080/14760584.2022.2021881.
- Czech Vaccinology Society. Recommendations of the Czech Vaccinology Society of the J. E. Purkyně Czech Medical Association for Vaccination against Invasive Meningococcal Disease; 2020[accessed 2023 Feb] http://www.szu.cz/uploads/IMO/2020_Recommendation_vaccination_IMD.pdf.
- New Zealand Immunisation Advisory Centre. MenB Bexsero quick facts . [accessed 2023 Apr] https://www.immune.org.nz/factsheets/menb-bexsero.
- Ministry of Health New Zealand. Meningococcal disease . [accessed 2023 Apr] https://www.health.govt.nz/our-work/immunisation-handbook-2020/13-meningococcal-disease.
- Government of South Australia. National immunisation program March 2023 South Australia schedule. [accessed 2023 Apr] https://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/resources/national+immunisation+program+south+australia+schedule.
- FDA, Bexsero prescribing information. [accessed 2021 Nov] https://www.fda.gov/media/90996/download.
- EMA. Bexsero summary of product characteristics. [accessed 2021 Nov]. https://www.ema.europa.eu/en/documents/product-information/bexsero-epar-product-information_en.pdf.
- Mbaeyi SA, Bozio CH, Duffy J, Rubin LG, Hariri S, Stephens DS, MacNeil JR. Meningococcal vaccination: recommendations of the Advisory Committee on Immunization Practices, United States, 2020. MMWR Recomm Rep. 2020;69(9):1–41. doi:10.15585/mmwr.rr6909a1.
- Sulis G, Horn M, Borrow R, Basta NE. A comparison of national vaccination policies to prevent serogroup B meningococcal disease. Vaccine. 2022;40(26):3647–54. doi:10.1016/j.vaccine.2022.04.101.
- Marshall GS, Abbing-Karahagopian V, Marshall HS, Cenci S, Conway JH, Occhipinti E, Bekkat-Berkani R, Banzhoff A, Sohn W-Y. A comprehensive review of clinical and real-world safety data for the four-component serogroup B meningococcal vaccine (4CMenB). Expert Rev Vaccines. 2023;22(1):530–44. doi:10.1080/14760584.2023.2222015.
- Dolhain J, Janssens W, Dindore V, Mihalyi A. Infant vaccine co-administration: review of 18 years of experience with GSK’s hexavalent vaccine co-administered with routine childhood vaccines. Expert Rev Vaccines. 2020;19(5):419–43. doi:10.1080/14760584.2020.1758560.
- Chiu NC, Huang LM, Willemsen A, Bhusal C, Arora AK, Reynoso Mojares Z, Toneatto D. Safety and immunogenicity of a meningococcal B recombinant vaccine when administered with routine vaccines to healthy infants in Taiwan: a phase 3, open-label, randomized study. Hum Vaccin Immunother. 2018;14(5):1075–83. doi:10.1080/21645515.2018.1425659.
- Davis K, Valente Pinto M, Andrews NJ, Goldblatt D, Borrow R, Findlow H, Southern J, Partington J, Plested E, Patel S, et al. Immunogenicity of the UK group B meningococcal vaccine (4CMenB) schedule against groups B and C meningococcal strains (Sched3): outcomes of a multicentre, open-label, randomised controlled trial. Lancet Infect Dis. 2021;21(5):688–96. doi:10.1016/S1473-3099(20)30600-9.
- Gossger N, Snape MD, Yu LM, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Becker B, et al. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA. 2012;307(6):573–82. doi:10.1001/jama.2012.85.
- Macias Parra M, Gentile A, Vazquez Narvaez JA, Capdevila A, Minguez A, Carrascal M, Willemsen A, Bhusal C, Toneatto D. Immunogenicity and safety of the 4CMenB and MenACWY-CRM meningococcal vaccines administered concomitantly in infants: a phase 3b, randomized controlled trial. Vaccine. 2018;36(50):7609–17. doi:10.1016/j.vaccine.2018.10.096.
- Safadi M, Martinon-Torres F, Weckx LY, Moreira EDJ, da Fonseca Lima EJ, Mensi I, Calabresi M, Toneatto D. Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: a phase 3b, randomized controlled trial. Vaccine. 2017;35(16):2052–9. doi:10.1016/j.vaccine.2017.03.002.
- Safadi M, Martinon-Torres F, Weckx LY, Moreira EDJ, da Fonseca Lima EJ, Willemsen A, Toneatto D, Habib MA, Borys D. Immunogenicity of the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered concomitantly with the meningococcal serogroup B (4CMenB) vaccine in infants: a post-hoc analysis in a phase 3b, randomised, controlled trial. Vaccine. 2019;37(35):4858–63. doi:10.1016/j.vaccine.2019.07.021.
- Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013;381(9869):825–35. doi:10.1016/S0140-6736(12)61961-8.
- Zafack JG, Bureau A, Skowronski DM, De Serres G. Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials. BMJ Open. 2019;9(5):e026953. doi:10.1136/bmjopen-2018-026953.
- Prymula R, Esposito S, Zuccotti GV, Xie F, Toneatto D, Kohl I, Dull PM. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I). Hum Vaccin Immunother. 2014;10(7):1993–2004. doi:10.4161/hv.28666.
- Findlow J, Bai X, Findlow H, Newton E, Kaczmarski E, Miller E, Borrow R. Safety and immunogenicity of a four-component meningococcal group B vaccine (4CMenB) and a quadrivalent meningococcal group ACWY conjugate vaccine administered concomitantly in healthy laboratory workers. Vaccine. 2015;33(29):3322–30. doi:10.1016/j.vaccine.2015.05.027.
- Hall GC, Douglas I, Heath PT, Prabhakar P, Rosillon D, Khan J, Abbing-Karahagopian V. Post-licensure observational safety study after meningococcal B vaccine 4CMenB (Bexsero) vaccination within the routine UK immunisation program. Vaccine. 2021;39(24):3296–303. doi:10.1016/j.vaccine.2021.02.065.
- Pillsbury A, Quinn H, Cashman P, Leeb A, Macartney K. Active SMS-based influenza vaccine safety surveillance in Australian children. Vaccine. 2017;35(51):7101–6. doi:10.1016/j.vaccine.2017.10.091.
- De Serres G, Billard MN, Gariépy MC, Rouleau I, Toth E, Landry M, Boulianne N, Gagné H, Gilca V, Deceuninck G, et al. Short-term safety of 4CMenB vaccine during a mass meningococcal B vaccination campaign in Quebec, Canada. Vaccine. 2018;36(52):8039–46. doi:10.1016/j.vaccine.2018.10.095.
- Alderfer J, Srivastava A, Isturiz R, Burman C, Absalon J, Beeslaar J, Perez J. Concomitant administration of meningococcal vaccines with other vaccines in adolescents and adults: a review of available evidence. Hum Vaccin Immunother. 2019;15(9):2205–16. doi:10.1080/21645515.2019.1581542.
- O’Ryan M, Stoddard J, Toneatto D, Wassil J, Dull PM. A multi-component meningococcal serogroup B vaccine (4CMenB): the clinical development program. Drugs. 2014;74(1):15–30. doi:10.1007/s40265-013-0155-7.
- Bryan P, Seabroke S, Wong J, Donegan K, Webb E, Goldsmith C, Vipond C, Feavers I. Safety of multicomponent meningococcal group B vaccine (4CMenB) in routine infant immunisation in the UK: a prospective surveillance study. Lancet Child Adolesc Health. 2018;6:395–403. doi:10.1016/S2352-4642(18)30103-2.
- Esposito S, Prymula R, Zuccotti GV, Xie F, Barone M, Dull PM, Toneatto D. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II). Hum Vaccin Immunother. 2014;10(7):2005–14. doi:10.4161/hv.29218.
- Dubus M, Ladhani S, Vasu V. Prophylactic paracetamol after meningococcal B vaccination reduces postvaccination fever and septic screens in hospitalized preterm infants. Pediatr Infect Dis J. 2020;39(1):78–80. doi:10.1097/INF.0000000000002507.
- Joint Committee on Vaccination and Immunisation (JCVI). JCVI position statement on use of BEXSERO® meningococcal B vaccine in the UK ; 2014 [accessed 2022 Feb] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/294245/JCVI_Statement_on_MenB.pdf.
- Isitt C, Cosgrove CA, Ramsay ME, Ladhani SN. Success of 4CMenB in preventing meningococcal disease: evidence from real-world experience. Arch Dis Child. 2020;105(8):784–90. doi:10.1136/archdischild-2019-318047.
- World Health Organization. Defeating meningitis by 2030; 2020 [accessed 2023 Apr] https://www.who.int/initiatives/defeating-meningitis-by-2030.
- Government of Andorra. Calendari de vacunacions; 2019 [accessed 2023 Apr] https://www.salut.ad/images/stories/Salut/pdfs/temes_salut/Calendari_vacunacions.pdf.
- Ministry of Health Andorra. Recomanacions sobre l’administració de la vacunació enfront sel meningococ B (Bexsero) ; 2016 [accessed 2023 Apr] http://www.salut.ad/images/stories/Salut/pdfs/temes_salut/Recomanacions_Vacuna_Bexero.pdf.
- Vomáčka J. Vaccination against infectious diseases in the Czech Republic. [accessed 2023 Apr] http://www.mudrvomacka.cz/index.php?option=com_content&view=article&id=8&Itemid=152&lang=en.
- Ministry of Health France. Calendrier des vaccinations et recommandations vaccinales 2022 ; 2022 [accessed 2023 Mar]https://sante.gouv.fr/IMG/pdf/calendrier_vaccinal_2022_mis_a_jour_juin_2022_v2.pdf.
- Ministry of Health Italy. Piano nazionale prevenzione vaccinale 2017–2019 ; 2017 [accessed 2023 Apr] http://www.salute.gov.it/imgs/C_17_pubblicazioni_2571_allegato.pdf.
- Ministry of Health Republic of Lithuania. Dėl lietuvos respublikos sveikatos apsaugos ministro. 2015 m. BIRŽELIO 12 d. įsakymo nr. V-757 „DĖL Lietuvos respublikos vaikų profilaktinių skiepijimų kalendoriaus patvirtinimo“pakeitimo ; 2015 [accessed 2023 Apr] https://eseimas.lrs.lt/portal/legalAct/lt/TAD/f4a925d0f50f11e79a1bc86190c2f01a?positionInSearchResults=0&searchModelUUID=1561434a-b283-4be2-87f5-4f556ad37c32.
- Government of Malta. National immunisation schedule. [accessed 2023 Apr] https://deputyprimeminister.gov.mt/en/phc/pchyhi/Pages/National-Immunisation-Schedule.aspx#.
- Comissão de Vacinas da Sociedade de Infeciologia Pediátrica da Sociedade Portuguesa de Pediatria. Recomendações sobre vacinas extra programa nacional de vacinação 2020 ; 2020 [accessed 2023 Apr] https://www.spp.pt/UserFiles/file/Seccao_Infecciologia/recomendacoes%20vacinas_sip_final_28set_2.pdf.
- Ministry of Health Portugal. Aprova o novo esquema vacinal do Programa Nacional de Vacinação (PNV), revogando, com exceção do seu n. 6, o Despacho n.° 10441/2016, de 9 de agosto ; 2019 [accessed 2023 Apr] https://dre.pt/application/conteudo/127608823.
- Republic of Ireland Health Service Executive. Immunisation schedule ; 2020 [accessed 2023 Apr] https://www.hse.ie/eng/health/immunisation/pubinfo/pcischedule/immschedule/.
- Institute for Social Security Republic of San Marino. Vaccinazioni pediatriche raccomandate: calendario vaccinale; 2017 [accessed 2023 Apr] https://www.iss.sm/on-line/home/vaccini-e-vaccinazioni/vaccinazioni-raccomandate.html.
- Sistema Nacional de Salud. Consejo Interritorial. Calendario común de vacunación a lo largo de toda la vida. Calendario recomendado año 2023. [accessed 2023 Mar] https://www.sanidad.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/calendario-y-coberturas/docs/CalendarioVacunacion_Todalavida.pdf .
- Ministry of Health Spain. Recomendaciones de vacunación frente a la enfermedad meningocócica invasiva por serogrupo B ; 2022 [accessed 2023 Apr] https://www.sanidad.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/comoTrabajamos/docs/MenB_2022.pdf.
- Asociación Española de Pediatría (AEP). Calendario de immunizaciones AEP 2023. [accessed 2023 Apr] https://vacunasaep.org/profesionales/calendario-de-inmunizaciones-de-la-aep-2023.
- UK Health Security Agency. The complete routine immunisation schedule from February 2022 ; 2022 [accessed 2023 Apr] https://www.gov.uk/government/publications/the-complete-routine-immunisation-schedule/the-complete-routine-immunisation-schedule-from-february-2022.
- Marshall HS, Lally N, Flood L, Phillips P. First statewide meningococcal B vaccine program in infants, children and adolescents: evidence for implementation in South Australia. Med J Aust. 2020;212(2):89–93. doi:10.5694/mja2.50481.
- Australian Technical Advisory Group on Immunisation (ATAGI). Australian immunisation handbook. Canberra: Care AGDoHaA. [accessed 2022 Feb] https://immunisationhandbook.health.gov.au/.
- Masters NB, Wagner AL, Carlson BF, Boulton ML. Vaccination timeliness and co-administration among Kenyan children. Vaccine. 2018;36(11):1353–60. doi:10.1016/j.vaccine.2018.02.001.
- O’Donnell S, Dubé E, Tapiero B, Gagneur A, Doll MK, Quach C. Determinants of under-immunization and cumulative time spent under-immunized in a Quebec cohort. Vaccine. 2017;35(43):5924–31. doi:10.1016/j.vaccine.2017.08.072.
- McNamara LA, Shumate AM, Johnsen P, MacNeil JR, Patel M, Bhavsar T, Cohn AC, Dinitz-Sklar J, Duffy J, Finnie J, et al. First use of a serogroup B meningococcal vaccine in the US in response to a university outbreak. Pediatrics. 2015;135(5):798–804. doi:10.1542/peds.2014-4015.
- Watson PS, Turner DP. Clinical experience with the meningococcal B vaccine, Bexsero®: prospects for reducing the burden of meningococcal serogroup B disease. Vaccine. 2016;34(7):875–80. doi:10.1016/j.vaccine.2015.11.057.
- Thabuis A, Tararbit K, Taha MK, Dejour-Salamanca D, Ronin V, Parent du Chatelet I, Spaccaferri G. Community outbreak of serogroup B invasive meningococcal disease in Beaujolais, France, February to June 2016: from alert to targeted vaccination. Euro Surveill. 2018;23(28):1700590. doi:10.2807/1560-7917.ES.2018.23.28.1700590.
- Australia DoHaAC. Bexsero meningococcal B vaccine. Final update - monitoring finds no new or unexpected safety issues ; 2016 [accessed 2023 Apr] https://www.tga.gov.au/news/safety-alerts/bexsero-meningococcal-b-vaccine.
- Italian Medicines Agency. Rapporto vaccini 2017. La sorveglianza post-marketing in Italia ; 2017 [accessed 2023 Apr] www.aifa.gov.it/sites/default/files/Rapp_Vaccini_2017_0.pdf.
- Marshall HS, Koehler AP, Wang B, A’Houre M, Gold M, Quinn H, Crawford N, Pratt N, Sullivan TR, Macartney K, et al. Safety of meningococcal B vaccine (4CMenB) in adolescents in Australia. Vaccine. 2020;38(37):5914–22. doi:10.1016/j.vaccine.2020.07.009.
- Ladhani SN, Andrews N, Parikh SR, Campbell H, White J, Edelstein M, Bai X, Lucidarme J, Borrow R, Ramsay ME, et al. Vaccination of infants with meningococcal group B vaccine (4CMenB) in England. N Engl J Med. 2020;382(4):309–17. doi:10.1056/NEJMoa1901229.
- Rodrigues FMP, Marlow R, Simões MJ, Danon L, Ladhani S, Finn A. Association of use of a meningococcus group B vaccine with group B invasive meningococcal disease among children in Portugal. JAMA. 2020;324(21):2187–94. doi:10.1001/jama.2020.20449.
- Azzari C, Moriondo M, Nieddu F, Guarnieri V, Lodi L, Canessa C, Indolfi G, Giovannini M, Napoletano G, Russo F, et al. Effectiveness and impact of the 4CMenB vaccine against group B meningococcal disease in two Italian regions using different vaccination schedules: a five-year retrospective observational study (2014–2018). Vaccines (Basel). 2020;8(3):469. doi:10.3390/vaccines8030469.
- Castilla J, García Cenoz M, Abad R, Sánchez-Cambronero L, Lorusso N, Izquierdo C, Cañellas Llabrés S, Roig J, Malvar A, González Carril F, et al. Effectiveness of a meningococcal group B vaccine (4CMenB) in children. N Engl J Med. 2023;388(5):427–38. doi:10.1056/NEJMoa2206433.
- Marshall HS, McMillan M, Koehler AP, Lawrence A, Sullivan TR, MacLennan JM, Maiden MCJ, Ladhani SN, Ramsay ME, Trotter C, et al. Meningococcal B vaccine and meningococcal carriage in adolescents in Australia. N Engl J Med. 2020;382(4):318–27. doi:10.1056/NEJMoa1900236.
- Bauwens J, de Lusignan S, Sherlock J, Ferreira F, Künzli N, Bonhoeffer J. Co-administration of routine paediatric vaccines in England often deviates from the immunisation schedule. VaccineX. 2021;9:100115. doi:10.1016/j.jvacx.2021.100115.
- Pingali C, Yankey D, Elam-Evans LD, Markowitz LE, Valier MR, Fredua B, Crowe SJ, Stokley S, Singleton JA. National vaccination coverage among adolescents aged 13–17 years — National Immunization Survey-Teen, United States, 2021. Morb Mortal Wkly Rep. 2022;71(35):1101–8. doi:10.15585/mmwr.mm7135a1.
- Packnett ER, Zimmerman NM, Kim G, Novy P, Morgan LC, Chime N, Ghaswalla P. A real-world claims data analysis of meningococcal serogroup B vaccine series completion and potential missed opportunities in the United States. Pediatr Infect Dis J. 2022;41(4):e158–e65. doi:10.1097/INF.0000000000003455.
- Bakhache P, Rodrigo C, Davie S, Ahuja A, Sudovar B, Crudup T, Rose M. Health care providers’ and parents’ attitudes toward administration of new infant vaccines—a multinational survey. Eur J Pediatr. 2013;172(4):485–92. doi:10.1007/s00431-012-1904-4.
- Ladhani SN, Riordan A. The yin and yang of fever after meningococcal B vaccination. Arch Dis Child. 2017;102(10):881–2. doi:10.1136/archdischild-2017-313419.
- Koufoglou E, Kourlaba G, Michos A. Effect of prophylactic administration of antipyretics on the immune response to pneumococcal conjugate vaccines in children: a systematic review. Pneumonia (Nathan). 2021;13(1):7. doi:10.1186/s41479-021-00085-8.
- Falup-Pecurariu O, Man SC, Neamtu ML, Chicin G, Baciu G, Pitic C, Cara AC, Neculau AE, Burlea M, Brinza IL, et al. Effects of prophylactic ibuprofen and paracetamol administration on the immunogenicity and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine (PHiD-CV) co-administered with DTPa-combined vaccines in children: an open-label, randomized, controlled, non-inferiority trial. Hum Vaccin Immunother. 2017;13(3):649–60. doi:10.1080/21645515.2016.1223001.
- Muse D, Christensen S, Bhuyan P, Absalon J, Eiden JJ, Jones TR, York LJ, Jansen KU, O’Neill RE, Harris SL, et al. A phase 2, randomized, active-controlled, observer-blinded study to assess the immunogenicity, tolerability and safety of bivalent rLP2086, a meningococcal serogroup B vaccine, coadministered with tetanus, diphtheria and acellular pertussis vaccine and serogroup A, C, Y and W-135 meningococcal conjugate vaccine in healthy US adolescents. Pediatr Infect Dis J. 2016;35(6):673–82. doi:10.1097/INF.0000000000001124.
- Jafri RZ, Ali A, Messonnier NE, Tevi-Benissan C, Durrheim D, Eskola J, Fermon F, Klugman KP, Ramsay M, Sow S, et al. Global epidemiology of invasive meningococcal disease. Popul Health Metr. 2013;11(1):17. doi:10.1186/1478-7954-11-17.
- Niccolai LM, Hansen CE. Suboptimal uptake of meningococcal vaccines among older adolescents: barriers, solutions, and future research directions. Hum Vaccin Immunother. 2020;16(12):3208–12. doi:10.1080/21645515.2020.1754052.
- ClinicalTrials.gov. NCT04502693. Effectiveness of GlaxoSmithKline Biologicals S.A's (GSK's) meningococcal group B and combined ABCWY vaccines in healthy adolescents and young adults. [accessed 2023 Apr] https://classic.clinicaltrials.gov/ct2/show/NCT04502693 .
- Bekkat-Berkani R, Fragapane E, Preiss S, Rappuoli R, Sohn WY, Soumahoro L, Vadivelu K. Public health perspective of a pentavalent meningococcal vaccine combining antigens of MenACWY-CRM and 4CMenB. J Infect. 2022;85(5):481–91. doi:10.1016/j.jinf.2022.09.001.