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

被引:1
作者
Marshall, Gary S. [1 ,2 ]
Pelton, Stephen, I [3 ]
Robertson, Corwin A. [4 ]
Oster, Philipp [5 ]
机构
[1] Norton Childrens, Div Pediat Infect Dis, Louisville, KY USA
[2] Univ Louisville, Sch Med, Louisville, KY 40292 USA
[3] Boston Univ, Sch Med, Dept Pediat, Boston, MA 02118 USA
[4] Sanofi, US Med Affairs, Discovery Dr, Swiftwater, PA USA
[5] Sanofi, Global Med Affairs, Lyon, France
关键词
Immunogenicity; invasive meningococcal disease; IMD; MenACWY-CRM; MenACWY-D; MenACWY-TT; MenACYW-TT; MenQuadfi; meningococcal conjugate vaccine; safety; vaccine recommendations; GUILLAIN-BARRE-SYNDROME; REPORTING SYSTEM VAERS; PHASE-III; GLOBAL EPIDEMIOLOGY; FULLY-LIQUID; DISEASE; CRM; ADULTS; ADOLESCENTS; IMPACT;
D O I
10.1080/21645515.2022.2099142
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
Vaccination offers the best way to prevent invasive meningococcal disease (IMD). As demonstrated in countries with national immunization programs (NIPs) against IMD, meningococcal conjugate vaccines have contributed to significant declines in incidence. Since some meningococcal vaccines are associated with modest immunogenicity in infants, possible immunological interference upon concomitant administration with some pediatric vaccines, and administration errors resulting from improper reconstitution, opportunities for improvement exist. A quadrivalent conjugate vaccine, MenQuadfi (R) (Meningococcal [Serogroups A, C, Y, and W] Conjugate Vaccine; Sanofi, Swiftwater, Pennsylvania), was approved in 2020 for the prevention of IMD caused by meningococcal serogroups A, C, W, and Y in individuals >= 2 years of age in the United States. Five pivotal studies and one ancillary study supported approval in the United States; clinical trials in infants are ongoing. Data on the immunogenicity and safety of this vaccine are presented, and its potential value in clinical practice is discussed.
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页数:17
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[21]   Persistence of antibodies for 42 months following vaccination of adolescents with a meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine (MenACWY-TT) [J].
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[24]   Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Adolescents and Young Adults 10 to 25 Years of Age [J].
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[27]   Immunogenicity and safety of a meningococcal serogroups A and C tetanus toxoid conjugate vaccine (MenAC-TT): two immune schedules in toddles aged 12-23 months in China [J].
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