Immunogenicity and safety of MenACWY-TT, a quadrivalent meningococcal tetanus toxoid conjugate vaccine recently licensed in the United States for individuals ≥2 years of age

References

• Pace D, Pollard AJ. Meningococcal disease: clinical presentation and sequelae. Vaccine. 2012;30(Suppl 2):1–17. doi:10.1016/j.vaccine.2011.12.062.
   Google Scholar
• Rouphael NG, Stephens DS. Neisseria meningitidis: biology, microbiology, and epidemiology. Methods Mol Biol. 2012;799:1–20.
   PubMedGoogle Scholar
• Mbaeyi S, Duffy J, and McNamara LA. Meningococcal disease. In: Hamborsky J, Kroger A, Wolfe S, editors. Epidemiology and prevention of vaccine-preventable diseases. Washington DC: Public Health Foundation. 207–224; 2015.
   Google Scholar
• Stephens DS. Biology and pathogenesis of the evolutionarily successful, obligate human bacterium Neisseria meningitidis. Vaccine. 2009;27 Suppl 2:B71–7. doi:10.1016/j.vaccine.2009.04.070.
   PubMed Web of Science ®Google Scholar
• Dos Santos Souza I, Ziveri J, Bouzinba-Segard H, Morand P, Bourdoulous S. Meningococcus, this famous unknown. C R Biol. 2021;344:127–143.
   PubMed Web of Science ®Google Scholar
• Gallacher SD, Seaton A. Meningococcal meningitis and COVID-19 co-infection. BMJ Case Rep. 2020;13(8):e237366. doi:10.1136/bcr-2020-237366.
   PubMedGoogle Scholar
• Jacobs JH, Viboud C, Tchetgen ET, Schwartz J, Steiner C, Simonsen L, Lipsitch M. The association of meningococcal disease with influenza in the United States, 1989–2009. PLoS One. 2014;9:e107486. doi:10.1371/journal.pone.0107486.
   PubMed Web of Science ®Google Scholar
• Siddiqui JA, Ameer MA, Gulick PG. Meningococcemia. StatPearls. Treasure Island (FL): StatPearls Publishing LLC.; 2021.
   Google Scholar
• World Health Organization (WHO). Meningococcal meningitis - Fact sheet. Geneva, Switzerland: World Health Organization (WHO); 2018.
   Google Scholar
• Pelton SI. The global evolution of meningococcal epidemiology following the introduction of meningococcal vaccines. J Adolesc Health. 2016;59(2):S3–S11. doi:10.1016/j.jadohealth.2016.04.012.
   PubMed Web of Science ®Google Scholar
• Borrow R, Alarcon P, Carlos J, Caugant DA, Christensen H, Debbag R, De Wals P, Echániz-Aviles G, Findlow J, et al. The Global Meningococcal Initiative: global epidemiology, the impact of vaccines on meningococcal disease and the importance of herd protection. Expert Rev Vaccines. 2017;16:313–328. doi:10.1080/14760584.2017.1258308.
   PubMed Web of Science ®Google Scholar
• United States Centers for Disease Control and Prevention. Enhanced Meningococcal Disease Surveillance Report, 2018. Atlanta, Georgia: Centers for Disease Control and Prevention, 2018.
   Google Scholar
• MacNeil JR, Blain AE, Wang X, Cohn AC. Current epidemiology and trends in meningococcal disease-United States, 1996-2015. Clin Infect Dis. 2018;66:1276–1281. doi:10.1093/cid/cix993.
   PubMed Web of Science ®Google Scholar
• Peterson ME, Li Y, Bita A, Moureau A, Nair H, Kyaw MH, Abad R, Bailey F, Garcia IDLF, Decheva A, et al. Meningococcal serogroups and surveillance: a systematic review and survey. J Glob Health. 2019;9:010409. doi:10.7189/jogh.09.010409.
   PubMed Web of Science ®Google Scholar
• Xie O, Pollard AJ, Mueller JE, Norheim G. Emergence of serogroup X meningococcal disease in Africa: need for a vaccine. Vaccine. 2013;31:2852–2861. doi:10.1016/j.vaccine.2013.04.036.
   PubMed Web of Science ®Google Scholar
• European Center for Disease Prevention and Control. Surveillance Atlas of Infectious Diseases - Invasive Meningococcal Disease. Solna, Sweden: European Center for Disease Prevention and Control; 2017.
   Google Scholar
• Public Health England. Meningococcal group W (MenW) immunisation advised for 14 to 18 year-olds. London, UK: Public Health England; 2015.
   Google Scholar
• Knol MJ, Ruijs WL, Antonise-Kamp L, de Melker HE, van der Ende A. Implementation of MenACWY vaccination because of ongoing increase in serogroup W invasive meningococcal disease, the Netherlands, 2018. Euro Surveill. 2018;23. doi:10.2807/1560-7917.ES.2018.23.16.18-00158.
   PubMedGoogle Scholar
• Booy R, Gentile A, Nissen M, Whelan J, Abitbol V. Recent changes in the epidemiology of Neisseria meningitidis serogroup W across the world, current vaccination policy choices and possible future strategies. Hum Vaccin Immunother. 2019;15:470–480. doi:10.1080/21645515.2018.1532248.
   PubMed Web of Science ®Google Scholar
• Taha MK, Achtman M, Alonso JM, Greenwood B, Ramsay M, Fox A, Gray S, Kaczmarski E. Serogroup W135 meningococcal disease in Hajj pilgrims. Lancet. 2000;356:2159. doi:10.1016/S0140-6736(00)03502-9.
   PubMed Web of Science ®Google Scholar
• Yezli S. The threat of meningococcal disease during the Hajj and Umrah mass gatherings: a comprehensive review. Travel Med Infect Dis. 2018;24:51–58. doi:10.1016/j.tmaid.2018.05.003.
   PubMed Web of Science ®Google Scholar
• Guiddir T, Gros M, Hong E, Terrade A, Denizon M, Deghmane AE, Taha M-K. Unusual initial abdominal presentations of invasive meningococcal disease. Clin Infect Dis. 2018;67:1220–1227. doi:10.1093/cid/ciy257.
   PubMed Web of Science ®Google Scholar
• Houweling BM, van Meurs SJ, Versluis J, Grewal S, Verkaik NJ, van den Akker JPC. Massive diarrhoea and sepsis due to an infection with Neisseria meningitidis serogroup W. Neth J Med. 2019;77:116–118.
   PubMed Web of Science ®Google Scholar
• Aung M, Raith E, Williams E, Burrell AJ. Severe meningococcal serogroup W sepsis presenting as myocarditis: a case report and review of literature. J Intensive Care Soc. 2019;20:182–186. doi:10.1177/1751143718794127.
   PubMedGoogle Scholar
• Stinson C, Burman C, Presa J, Abalos M. Atypical presentation of invasive meningococcal disease caused by serogroup W meningococci. Epidemiol Infect. 2020;148:e12. doi:10.1017/S0950268819002152.
   PubMed Web of Science ®Google Scholar
• Loenenbach AD, van der Ende A, de Melker HE, Sanders EAM, Knol MJ. The clinical picture and severity of invasive meningococcal disease serogroup W compared with other serogroups in the Netherlands, 2015-2018. Clin Infect Dis. 2020;70:2036–2044. doi:10.1093/cid/ciz578.
   PubMed Web of Science ®Google Scholar
• Wang B, Santoreneos R, Giles L, Haji Ali Afzali H, Marshall H. Case fatality rates of invasive meningococcal disease by serogroup and age: a systematic review and meta-analysis. Vaccine. 2019;37:2768–2782. doi:10.1016/j.vaccine.2019.04.020.
   PubMed Web of Science ®Google Scholar
• Cohn AC, MacNeil JR, Harrison LH, Hatcher C, Theodore J, Schmidt M, Pondo T, Arnold K, Baumbach J, Bennett N, et al. Changes in Neisseria meningitidis disease epidemiology in the United States, 1998–2007: Implications for prevention of Meningococcal Disease. Clin Infect Dis. 2010;50:184–191. doi:10.1086/649209.
   PubMed Web of Science ®Google Scholar
• Macneil JR, Cohn AC, Zell ER, Schmink S, Miller E, Clark T, Messonnier NE. Early estimate of the effectiveness of quadrivalent meningococcal conjugate vaccine. Pediatr Infect Dis J. 2011;30:451–455. doi:10.1097/INF.0b013e31820a8b3c.
   PubMed Web of Science ®Google Scholar
• Mbaeyi S, Pondo T, Blain A, Yankey D, Potts C, Cohn A, Hariri S, Shang N, MacNeil JR. Incidence of meningococcal disease before and after implementation of quadrivalent meningococcal conjugate vaccine in the United States. JAMA Pediatr. 2020;174:843–851. doi:10.1001/jamapediatrics.2020.1990.
   PubMed Web of Science ®Google Scholar
• Harcourt BH, Anderson RD, Wu HM, Cohn AC, MacNeil JR, Taylor TH, Wang X, Clark TA, Messonnier NE, Mayer LW, et al. Population-based surveillance of Neisseria meningitidis antimicrobial resistance in the United States. Open Forum Infect Dis. 2015;2:ofv117. doi:10.1093/ofid/ofv117.
   PubMed Web of Science ®Google Scholar
• McNamara LA, Potts C, Blain AE, Retchless AC, Reese N, Swint S, Lonsway D, Karlsson M, Lunquest K, Sweitzer JJ et al. Detection of ciprofloxacin-resistant, β-lactamase–producing Neisseria meningitidis serogroup Y isolates — United States, 2019–2020. MMWR Morb Mortal Wkly Rep. 2020;69(24):735–739. doi:10.15585/mmwr.mm6924a2.
   PubMed Web of Science ®Google Scholar
• Granoff DM, Pollard AJ. Reconsideration of the use of meningococcal polysaccharide vaccine. Pediatr Infect Dis J. 2007;26:716–722. doi:10.1097/INF.0b013e3180cc2c25.
   PubMed Web of Science ®Google Scholar
• Khatami A, Pollard AJ. The epidemiology of meningococcal disease and the impact of vaccines. Expert Rev Vaccines. 2010;9:285–298. doi:10.1586/erv.10.3.
   PubMed Web of Science ®Google Scholar
• Clark SA, Borrow R. Herd protection against Meningococcal disease through vaccination. Microorganisms. 2020;8:1675. doi:10.3390/microorganisms8111675.
   PubMed Web of Science ®Google Scholar
• Dretler AW, Rouphael NG, Stephens DS. Progress toward the global control of Neisseria meningitidis: 21st century vaccines, current guidelines, and challenges for future vaccine development. Hum Vaccin Immunother. 2018;14:1146–1160. doi:10.1080/21645515.2018.1451810.
   PubMed Web of Science ®Google Scholar
• Christodoulides M, Heckels J. Novel approaches to Neisseria meningitidis vaccine design. Pathog Dis. 2017;75. doi:10.1093/femspd/ftx033.
   PubMed Web of Science ®Google Scholar
• Huang L, Mauskopf J, Farkouh R, Masaquel C. Use of cost-effectiveness analyses for decisions about vaccination programs for Meningococcal disease in the United States, United Kingdom, the Netherlands, and Canada. Expert review of vaccines 2021.
   Google Scholar
• Tin Tin Htar M, Jackson S, Balmer P, Serra LC, Vyse A, Slack M, Riera-Montes M, Swerdlow DL, Findlow J. Systematic literature review of the impact and effectiveness of monovalent meningococcal C conjugated vaccines when used in routine immunization programs. BMC Public Health. 2020;20:1890. doi:10.1186/s12889-020-09946-1.
   PubMed Web of Science ®Google Scholar
• Presa J, Findlow J, Vojicic J, Williams S, Serra L. Epidemiologic trends, global shifts in meningococcal vaccination guidelines, and data supporting the use of MenACWY-TT vaccine: a review. Infect Dis Ther. 2019;8:307–333. doi:10.1007/s40121-019-0254-1.
   PubMed Web of Science ®Google Scholar
• 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;69:1–41. doi:10.15585/mmwr.rr6909a1.
   PubMed Web of Science ®Google Scholar
• Sanofi Pasteur. Menactra®, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Solution for Intramuscular Injection. Swiftwater, PA: Sanofi Pasteur Inc; 2016.
   Google Scholar
• GSK Vaccines Srl. MENVEO [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM₁₉₇ Conjugate Vaccine]. Bellaria-Rosia, Sovicille, Italy: GSK Vaccines, Srl; 2020.
   Google Scholar
• Sanofi Pasteur I. MenQuadfi™, Meningococcal (Groups A, C, Y, W) Conjugate Vaccine Solution for Intramuscular Injection. Swiftwater, PA: Sanofi Pasteur, Inc; 2020.
   Google Scholar
• Myers TR, McNeil MM, Ng CS, Li R, Lewis PW, Cano MV. Adverse events following quadrivalent meningococcal CRM-conjugate vaccine (Menveo®) reported to the Vaccine Adverse Event Reporting system (VAERS), 2010-2015. Vaccine. 2017;35:1758–1763. doi:10.1016/j.vaccine.2017.02.030.
   PubMed Web of Science ®Google Scholar
• Myers TR, McNeil MM, Ng CS, Li R, Marquez PL, Moro PL, Omer SB, Cano MV. Adverse events following quadrivalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) reported to the Vaccine Adverse Event Reporting System (VAERS), 2005–2016. Vaccine. 2020;38:6291–6298. doi:10.1016/j.vaccine.2020.07.039.
   PubMed Web of Science ®Google Scholar
• Cohn AC, MacNeil JR, Harrison LH, Lynfield R, Reingold A, Schaffner W, Zell ER, Plikaytis B, Wang X, Messonnier NE, et al. Effectiveness and duration of protection of one dose of a meningococcal conjugate vaccine. Pediatrics. 2017;139:139. doi:10.1542/peds.2016-2193.
   Web of Science ®Google Scholar
• Rennels M, King J Jr., Ryall R, Papa T, Froeschle J. Dosage escalation, safety and immunogenicity study of four dosages of a tetravalent meninogococcal polysaccharide diphtheria toxoid conjugate vaccine in infants. Pediatr Infect Dis J. 2004;23:429–435. doi:10.1097/01.inf.0000126297.28952.f8.
   PubMed Web of Science ®Google Scholar
• United States National Library of Medicine. Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years (NCT00874549). Bethesda, MD: National Institutes of Health; 2009.
   Google Scholar
• Stamboulian D, Lopardo G, Lopez P, Cortes-Barbosa C, Valencia A, Bedell L, Karsten A, Dull PM. Safety and immunogenicity of an investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America. Int J Infect Dis. 2010;14:e868–75. doi:10.1016/j.ijid.2010.03.017.
   PubMed Web of Science ®Google Scholar
• Ramasamy MN, Clutterbuck EA, Haworth K, Bowman J, Omar O, Thompson AJ, Blanchard-Rohner G, Yu L-M, Snape MD, Pollard AJ, et al. Randomized clinical trial to evaluate the immunogenicity of quadrivalent meningococcal conjugate and polysaccharide vaccines in adults in the United kingdom. Clin Vaccine Immunol. 2014;21:1164–1168. doi:10.1128/CVI.00099-14.
   PubMed Web of Science ®Google Scholar
• Lalwani S, Agarkhedkar S, Gogtay N, Palkar S, Agarkhedkar S, Thatte U, Vakil H, Jonnalagedda R, Pedotti P, Hoyle M, et al. Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years. Int J Infect Dis. 2015;38:36–42. doi:10.1016/j.ijid.2015.07.003.
   PubMed Web of Science ®Google Scholar
• Pina LM, Bassily E, Machmer A, Hou V, Reinhardt A. Safety and immunogenicity of a quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine in infants and toddlers: three multicenter phase III studies. Pediatr Infect Dis J. 2012;31:1173–1183. doi:10.1097/INF.0b013e318268dfe4.
   PubMed Web of Science ®Google Scholar
• Klein NP, Reisinger KS, Johnston W, Odrljin T, Gill CJ, Bedell L, Dull P. Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants. Pediatr Infect Dis J. 2012;31:64–71. doi:10.1097/INF.0b013e31823dce5c.
   PubMed Web of Science ®Google Scholar
• Gasparini R, Tregnaghi M, Keshavan P, Ypma E, Han L, Smolenov I. Safety and Immunogenicity of a quadrivalent meningococcal conjugate vaccine and commonly administered vaccines after coadministration. Pediatr Infect Dis J. 2016;35:81–93. doi:10.1097/INF.0000000000000930.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate vaccine–United States, June-July 2005. MMWR Morb Mortal Wkly Rep 2005;54:1023–1025.
   PubMedGoogle Scholar
• Cho BH, Clark TA, Messonnier NE, Ortega-Sanchez IR, Weintraub E, Messonnier ML. MCV vaccination in the presence of vaccine-associated Guillain-Barré Syndrome risk: a decision analysis approach. Vaccine. 2010;28:817–822. doi:10.1016/j.vaccine.2009.10.050.
   PubMed Web of Science ®Google Scholar
• Velentgas P, Amato AA, Bohn RL, Chan KA, Cochrane T, Funch DP, Dashevsky I, Duddy AL, Gladowski P, Greenberg SA, et al. Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination. Pharmacoepidemiol Drug Saf. 2012;21:1350–1358. doi:10.1002/pds.3321.
   PubMed Web of Science ®Google Scholar
• Yih WK, Weintraub E, Kulldorff M. No risk of Guillain-Barré syndrome found after meningococcal conjugate vaccination in two large cohort studies. Pharmacoepidemiol Drug Saf. 2012;21:1359–1360. doi:10.1002/pds.3353.
   PubMed Web of Science ®Google Scholar
• Baxter R, Lewis N, Bakshi N, Vellozzi C, Klein NP. Recurrent Guillain-Barre syndrome following vaccination. Clin Infect Dis. 2012;54:800–804. doi:10.1093/cid/cir960.
   PubMed Web of Science ®Google Scholar
• Baxter R, Bakshi N, Fireman B, Lewis E, Ray P, Vellozzi C, Klein NP. Lack of association of Guillain-Barré syndrome with vaccinations. Clin Infect Dis. 2013;57:197–204. doi:10.1093/cid/cit222.
   PubMed Web of Science ®Google Scholar
• Tseng HF, Sy LS, Ackerson BK, Hechter RC, Tartof SY, Haag M, Slezak JM, Luo Y, Fischetti CA, Takhar HS, et al. Safety of quadrivalent meningococcal conjugate vaccine in 11- to 21-year-olds. Pediatrics. 2017; 139. doi:10.1542/peds.2016-2084
   PubMed Web of Science ®Google Scholar
• Hansen J, Zhang L, Klein NP, Robertson CA, Decker MD, Greenberg DP, Bassily E, Baxter R. Post-Licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine. Vaccine. 2017;35:6879–6884. doi:10.1016/j.vaccine.2017.09.032.
   PubMed Web of Science ®Google Scholar
• Hansen J, Zhang L, Eaton A, Baxter R, Robertson CA, Decker MD, Greenberg DP, Bassily E, Klein NP. Post-Licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and children. Vaccine. 2018;36:2133–2138. doi:10.1016/j.vaccine.2018.02.107.
   PubMed Web of Science ®Google Scholar
• Su JR, Miller ER, Duffy J, Baer BM, Cano MV. Notes from the Field: Administration Error Involving a Meningococcal Conjugate Vaccine–United States, March 1, 2010-September 22, 2015. MMWR Morb Mortal Wkly Rep. 2016;65:161–162. doi:10.15585/mmwr.mm6506a4.
   PubMed Web of Science ®Google Scholar
• Samad F, Burton SJ, Kwan D, Porter N, Smetzer J, Cohen MR, Tuttle J, Baker D, Doherty DE. Strategies to Reduce Errors Associated with 2-Component Vaccines. Pharmaceut Med. 2021;35:1–9. doi:10.1007/s40290-020-00362-9.
   PubMed Web of Science ®Google Scholar
• Tartof SY, Sy LS, Ackerson BK, Hechter RC, Haag M, Slezak JM, Luo Y, Fischetti CA, Takhar HS, Miao Y, et al. Safety of quadrivalent meningococcal conjugate vaccine in children 2–10 years. Pediatr Infect Dis J. 2017;36:1087–1092. doi:10.1097/INF.0000000000001696.
   PubMed Web of Science ®Google Scholar
• Kensinger R, Arunachalam AB. Preclinical development of the quadrivalent meningococcal (ACYW) tetanus toxoid conjugate vaccine, MenQuadfi®. Glycoconj J. 2022;39:381–392. doi:10.1007/s10719-022-10050-2.
   PubMed Web of Science ®Google Scholar
• United States Food and Drug Administration (FDA). Meningococcal (Groups A, C, Y, W) Conjugate Vaccine - BLA Approval. Rockville, MD: United States Food and Drug Administration (FDA); 2020.
   Google Scholar
• United States Food and Drug Administration (FDA). Meningococcal (Groups A, C, Y, W) Conjugate Vaccine - BLA Clinical Review Memorandum. Rockville, MD: United States Food and Drug Administration (FDA); 2020.
   Google Scholar
• Baccarini CI, Simon MW, Brandon D, Christensen S, Jordanov E, Dhingra MS. Safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine in healthy meningococcal-naïve children 2-9 years of age: a phase III, randomized study. Pediatr Infect Dis J. 2020;39:955–960. doi:10.1097/INF.0000000000002832.
   PubMed Web of Science ®Google Scholar
• Chang L-J, Hedrick J, Christensen S, Pan J, Jordanov E, Dhingra MS. A Phase II, randomized, immunogenicity and safety study of a quadrivalent meningococcal conjugate vaccine, MenACYW-TT, in healthy adolescents in the United States. Vaccine. 2020;38:3560–3569. doi:10.1016/j.vaccine.2020.03.017.
   PubMed Web of Science ®Google Scholar
• Dhingra MS, Peterson J, Hedrick J, Pan J, Neveu D, Jordanov E. Immunogenicity, safety and inter-lot consistency of a meningococcal conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study. Vaccine. 2020;38:5194–5201. doi:10.1016/j.vaccine.2020.06.013.
   PubMed Web of Science ®Google Scholar
• Áñez G, Hedrick J, Simon MW, Christensen S, Jeanfreau R, Yau E, Pan J, Jordanov E, Dhingra MS. Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study. Hum Vaccin Immunother. 2020;16:1292–1298. doi:10.1080/21645515.2020.1733867.
   PubMed Web of Science ®Google Scholar
• Kirstein J, Pina M, Pan J, Jordanov E, Dhingra MS. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adults 56 years of age and older: a Phase II randomized study. Hum Vaccin Immunother. 2020;16:1299–1305. doi:10.1080/21645515.2020.1733868.
   PubMed Web of Science ®Google Scholar
• Esteves-Jaramillo A, Koehler T, Jeanfreau R, Neveu D, Jordanov E, Singh Dhingra M. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in >/=56-year-olds: a Phase III randomized study. Vaccine. 2020;38:4405–4411. doi:10.1016/j.vaccine.2020.04.067.
   PubMed Web of Science ®Google Scholar
• Dhingra MS, Namazova-Baranova L, Arredondo-Garcia JL, Kim KH, Limkittikul K, Jantarabenjakul W, et al. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) administered concomitantly with other paediatric vaccines in toddlers: a phase III randomized study. Epidemiol Infect. 2021;149:1–10.
   Web of Science ®Google Scholar
• Piazza FM, Virta M, Paassilta M, Ukkonen B, Ahonen A, Esteves-Jaramillo A, Forsten A, Seppa I, Ding J, Neveu D, et al. Immunogenicity and safety of an investigational quadrivalent meningococcal conjugate vaccine administered as a booster dose in children vaccinated against meningococcal disease 3 years earlier as toddlers: a Phase III, open-label, multi-center study. Human Vaccines Immunother. 2022;18:1–10. doi:10.1080/21645515.2021.1902701.
   PubMed Web of Science ®Google Scholar
• van der Vliet D, Vesikari T, Sandner B, Martinón-Torres F, Muzsay G, Forsten A, Adelt T, Diaz Gonzalez C, Simko R, B’Chir S, et al. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) vs. A licensed quadrivalent meningococcal tetanus toxoid-conjugate vaccine in meningococcal vaccine-naïve and meningococcal C conjugate vaccine-primed toddlers: a phase III randomised study. Epidemiol Infect. 2021;149:e50. doi:10.1017/S0950268821000261.
   PubMed Web of Science ®Google Scholar
• Vesikari T, Borrow R, Forsten A, Findlow H, Dhingra MS, Jordanov E. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in healthy toddlers: a Phase II randomized study. Hum Vaccin Immunother. 2020;16:1306–1312. doi:10.1080/21645515.2020.1733869.
   PubMed Web of Science ®Google Scholar
• Martinón-Torres F, Bertrand-Gerentes I, Oster P. A novel vaccine to prevent meningococcal disease beyond the first year of life: an early review of MenACYW-TT. Expert Rev Vaccines. 2021;20:1123–1146. doi:10.1080/14760584.2021.1964962.
   PubMed Web of Science ®Google Scholar
• Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969;129:1307–1326. doi:10.1084/jem.129.6.1307.
   PubMed Web of Science ®Google Scholar
• Findlow J, Balmer P, Borrow R. A review of complement sources used in serum bactericidal assays for evaluating immune responses to meningococcal ACWY conjugate vaccines. Hum Vaccin Immunother. 2019;15:2491–2500. doi:10.1080/21645515.2019.1593082.
   PubMed Web of Science ®Google Scholar
• United States Food and Drug Administration (FDA). Vaccines and Related Biological Products Advisory Committee: FDA Briefing Document - Use of Serum Bactericidal Antibody as an Immunological Correlate for Demonstrating Effectiveness of Meningococcal Conjugate Vaccines (Serogroups A, C, Y, W-135) Administered to Children Less Than 2 Years of Age. Rockville, MD: United States Food and Drug Administration (FDA); 2011.
   Google Scholar
• United States Food and Drug Administration (FDA). MenQuadfi™ - Summary Basis for Regulatory Action, April 22, 2020. Rockville, MD: United States Food and Drug Administration (FDA); 2020.
   Google Scholar
• Rivera L, Schwarz TF, Kim KH, Kim YK, Behre U, Cha SH, Jo DS, Lee J, Lee J-S, Cheuvart B, et al. Immunogenicity and safety of the quadrivalent meningococcal vaccine MenACWY-TT co-administered with a combined diphtheria-tetanus-acellular pertussis vaccine versus their separate administration in adolescents and young adults: a phase III, randomized study. Vaccine. 2018;36:4750–4758. doi:10.1016/j.vaccine.2018.04.034.
   PubMed Web of Science ®Google Scholar
• Arguedas A, Soley C, Loaiza C, Rincon G, Guevara S, Perez A, Porras W, Alvarado O, Aguilar L, Abdelnour A, et al. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine. 2010;28:3171–3179. doi:10.1016/j.vaccine.2010.02.045.
   PubMed Web of Science ®Google Scholar
• Powers DC, Anderson EL, Lottenbach K, Mink CM. Reactogenicity and immunogenicity of a protein-conjugated pneumococcal oligosaccharide vaccine in older adults. J Infect Dis. 1996;173:1014–1018. doi:10.1093/infdis/173.4.1014.
   PubMed Web of Science ®Google Scholar
• Juergens C, Trammel J, Shoji Y, Patterson S, Watson W, Webber C, Gruber WC, Scott DA, Schmoele-Thoma B. Late onset of injection site reactions after vaccination with the 13-valent pneumococcal conjugate vaccine in adult study populations. Hum Vaccin Immunother. 2018;14:1948–1956. doi:10.1080/21645515.2018.1452576.
   PubMed Web of Science ®Google Scholar
• CDC. Meningococcal Disease in Florida 2022 - Serogroup C outbreak among men who have sex with men. Centers for Disease Control and Prevention (CDC), 2022.
   Google Scholar
• Oliver SE, Mbaeyi SA. A review of global epidemiology and response to meningococcal disease outbreaks among men who have sex with men, 2001–2018. Current Epidemiol Rep. 2018;5:321–330. doi:10.1007/s40471-018-0170-z.
   Google Scholar
• Parikh SR, Campbell H, Bettinger JA, Harrison LH, Marshall HS, Martinon-Torres F, Safadi MA, Shao Z, Zhu B, von Gottberg A, et al. The everchanging epidemiology of meningococcal disease worldwide and the potential for prevention through vaccination. J Infect. 2020;81:483–498. doi:10.1016/j.jinf.2020.05.079.
   PubMed Web of Science ®Google Scholar
• Dagan R, Poolman J, Siegrist CA. Glycoconjugate vaccines and immune interference: a review. Vaccine. 2010;28:5513–5523. doi:10.1016/j.vaccine.2010.06.026.
   PubMed Web of Science ®Google Scholar
• Dhingra MS, Namazova-Baranova L, Arredondo-Garcia JL, Kim K-H, Limkittikul K, and Jantarabenjakul W, et al. Immunogenicity and Safety of a Quadrivalent Meningococcal Tetanus Toxoid-Conjugate Vaccine (MenACYW-TT) Administered Concomitantly with Other Paediatric Vaccines in Toddlers: a Phase III randomized study. Epidemiol Infect. 149. 2021;E90.
   PubMed Web of Science ®Google Scholar
• Cornish M, Pina LM, Jezorwski J, DaCosta X, Rehm C, Dhingra MS Safety and immunogenicity of an investigational quadrivalent meningococcal conjugate vaccine (MenACYW-TT) administered to infants and toddlers (Abstract ID: 162). 20th International Pathogenic Neisseria Conference (IPNC). Manchester, United Kingdom, 2016:252.
   Google Scholar
• Wiedenmayer KA, Weiss S, Chattopadhyay C, Mukherjee A, Kundu R, Ayé R, Tediosi F, Hetzel MW, Tanner M. Simplifying paediatric immunization with a fully liquid DTP–HepB–Hib combination vaccine: Evidence from a comparative time-motion study in India. Vaccine. 2009;27:655–659. doi:10.1016/j.vaccine.2008.11.045.
   PubMed Web of Science ®Google Scholar
• De Coster I, Fournie X, Faure C, Ziani E, Nicolas L, Soubeyrand B, Van Damme P. Assessment of preparation time with fully-liquid versus non-fully liquid paediatric hexavalent vaccines. A time and motion study. Vaccine. 2015;33:3976–3982. doi:10.1016/j.vaccine.2015.06.030.
   PubMed Web of Science ®Google Scholar
• Orsi A, Azzari C, Bozzola E, Chiamenti G, Chirico G, Esposito S, Francia F, Lopalco P, Prato R, Russo R, et al. Hexavalent vaccines: characteristics of available products and practical considerations from a panel of Italian experts. J Prev Med Hyg. 2018;59:E107–e19.
   PubMedGoogle Scholar
• Mathijssen DAR, Heisen M, Clark-Wright JF, Wolfson LJ, Lu X, Carrol S, van Dijk BCP, Klijn SL, Alemayehu B. Budget impact analysis of introducing a non-reconstituted, hexavalent vaccine for pediatric immunization in the United Kingdom. Expert Rev Vaccines. 2020;19:1167–1175. doi:10.1080/14760584.2020.1873770.
   PubMed Web of Science ®Google Scholar
• Lucidarme J, Scott KJ, Ure R, Smith A, Lindsay D, Stenmark B, Jacobsson S, Fredlund H, Cameron JC, Smith-Palmer A, et al. An international invasive meningococcal disease outbreak due to a novel and rapidly expanding serogroup W strain, Scotland and Sweden, July to August 2015. Euro Surveill. 2016;21. doi:10.2807/1560-7917.ES.2016.21.45.30395
   Google Scholar
• United States Centers for Disease Control and Prevention (CDC). Outbreak of meningococcal disease associated with an elementary school – Oklahoma, March 2010. MMWR Morb Mortal Wkly Rep 2012;61:217–221.
   PubMedGoogle Scholar
• Barret AS, Clinard F, Taha MK, Girard I, Hong E, Tessier S, Zurbaran M, de Bort C, Antona D, Deghmane AE, et al. Cluster of serogroup W invasive meningococcal disease in a university campus. Médecine Et Maladies Infectieuses. 2020;50:335–341. doi:10.1016/j.medmal.2019.10.003.
   PubMed Web of Science ®Google Scholar
• United States Food and Drug Administration (FDA). MenQuadfi, Meningococcal (Groups A, C, Y, W) Conjugate Vaccine Solution for Intramuscular Injection - Prescribing Information. Rockville, MD: United States Food and Drug Administration (FDA); 2020.
   Google Scholar
• Keiser PB, Gill CJ. Defining efficacy in meningococcal vaccine trials. Clin Invest. 2012;2:589–601. doi:10.4155/cli.12.52.
   Google Scholar
• Jodar L, Cartwright K, Feavers IM. Standardisation and validation of serological assays for the evaluation of immune responses to Neisseria meningitidis serogroup a and C vaccines. Biologicals. 2000;28:193–197. doi:10.1006/biol.2000.0253.
   PubMedGoogle Scholar
• Cornish MJ, Hedrick JA, Gabrielsen AA, Johnson AD, Miriam Pina L, Rehm C, Pan J, Neveu D, Da Costa X, Jordanov E, et al. Safety and immunogenicity of an investigational quadrivalent meningococcal tetanus toxoid conjugate vaccine (MenACYW-TT) co-administered with routine pediatric vaccines in infants and toddlers: a Phase II study. Vaccine. 2022;40:1421–1438. doi:10.1016/j.vaccine.2022.01.050.
   PubMed Web of Science ®Google Scholar
• United States National Library of Medicine. A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers (MET39; NCT01049035). Bethesda, MD: National Institutes of Health; 2020.
   Google Scholar
• United States National Library of Medicine. Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered with Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe (MET58; NCT03547271). Bethesda, MD: National Institutes of Health; 2020.
   Google Scholar
• United States National Library of Medicine. Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers (MET41; NCT03673462). Bethesda, MD: National Institutes of Health; 2020.
   Google Scholar
• United States National Library of Medicine. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US (MET42; NCT03537508). Bethesda, MD: National Institutes of Health; 2021.
   Google Scholar
• United States National Library of Medicine. Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers (MET61; NCT03691610). Bethesda, MD: National Institutes of Health; 2021.
   Google Scholar
• United States National Library of Medicine. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly with Routine Pediatric Vaccines in the United Kingdom (MET52; NCT03632720). Bethesda, MD: National Institutes of Health; 2021.
   Google Scholar
• United States National Library of Medicine. Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico (MET33; NCT03630705). Bethesda, MD: National Institutes of Health; 2021.
   Google Scholar
• Peterson J, Deseda C, Julien K, Zambrano B, Áñez G, Jiayuan S, Pan J, Arroum H, Varghese K, Jordanov E, et al. 03. Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) administered as a booster dose in adults and adolescents vaccinated against meningococcal disease 3 - 6 years earlier. Open Forum Infect Dis. 2021;8: S125. doi:10.1093/ofid/ofab466.206.
   PubMedGoogle Scholar
• Robertson CA, Jacqmein J, Selmani A, Galarza K, Oster P. 1046. Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) administered as a booster to adults ≥ 59 years of age. Open Forum Infect Dis. 2021;8:S614–S5. doi:10.1093/ofid/ofab466.1240.
   Google Scholar
• United States National Library of Medicine. Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly with a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4) (MET59; NCT04084769). Bethesda, MD: National Institutes of Health; 2021.
   Google Scholar
• United States National Library of Medicine. Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine in Older Adults Who Received a Primary Vaccination (3 or More Years Earlier) in Study MET49 (MEQ00066; NCT04142242). Bethesda, MD: National Institutes of Health; 2019.
   Google Scholar