Meningococcal quadrivalent (Serogroups A, C, W135 and Y) tetanus toxoid conjugate vaccine (Nimenrix™)

Drugs

Volumn 72, Issue 18, 2012, Pages 2407-2430

  Croxtall, Jamie D ^a   Dhillon, Sohita ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Adis Drug Evaluations; Meningococcal infections; Meningococcal meningitis; Meningococcal vaccine groups A C Y W 135 conjugate

Indexed keywords

CARRIER PROTEIN; MENINGOCOCCUS VACCINE; POLYSACCHARIDE; TETANUS TOXOID;

ACTIVE IMMUNIZATION; ADULT; ANTIBODY TITER; ARTICLE; CONCENTRATION (PARAMETERS); DRUG INDUSTRY; DRUG TOLERABILITY; HUMAN; IMMUNOGENICITY; MENINGOCOCCOSIS; NEISSERIA MENINGITIDIS; RECIPIENT; TREATMENT RESPONSE;

ADOLESCENT; ADULT; ANIMALS; CHILD; CHILD, PRESCHOOL; HUMANS; INFANT; MENINGOCOCCAL INFECTIONS; MENINGOCOCCAL VACCINES; MIDDLE AGED; NEISSERIA MENINGITIDIS; RABBITS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SERUM BACTERICIDAL ANTIBODY ASSAY; TETANUS TOXOID; VACCINATION; VACCINES, COMBINED; VACCINES, CONJUGATE; YOUNG ADULT;

FLU VACCINE; NEISSERIA MENINGITIDIS; ORYCTOLAGUS CUNICULUS;

EID: 84871233650     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/11209580-000000000-00000     Document Type: Article

References (74)

1. Stephens DS, Greenwood B, Brandtzaeg P. Epidemic meningitis, meningococcaemia, and Neisseria meningitidis. Lancet 2007; 369 (9580); 2196-210
2. Trotter CL, Ramsay ME. Vaccination against meningococcal disease in Europe; review and recommendations for the use of conjugate vaccines. FEMS Microbiol Rev 2007; 31 (1); 101-7
3. Girard MP, Preziosi MP, Aguado MT, et al. A review of vaccine research and development; meningococcal disease. Vaccine 2006 May 29; 24 (22); 4692-700
4. Thigpen MC, Whitney CG, Messonnier NE, et al. Bacterial meningitis in the United States, 1998-2007. N Engl J Med 2011 May 26; 364 (21); 2016-25
5. Harrison LH. Epidemiological profile of meningococcal disease in the United States. Clin Infect Dis 2010; 50 Suppl. 2; S37-44
6. Harrison LH, Trotter CL, Ramsay ME. Global epidemiology of meningococcal disease. Vaccine 2009 Jun 24; 27 Suppl. 2; B51-63
7. Miller JM, Mesaros N, Van Der Wielen M, et al. Conjugate meningococcal vaccines development; GSK Biologicals experience. Adv Prev Med 2011; 2011; 846756
8. Mutonga DM, Pimentel G, Muindi J, et al. Epidemiology and risk factors for serogroup X meningococcal meningitis during an outbreak in western Kenya, 2005-2006. Am J Trop Med Hyg 2009 Apr; 80 (4); 619-24
9. Hill D, Griffiths N, Borodina E, et al. Cellular and molecular biology of Neisseria meningitidis colonization and invasive disease. Clin Sci (Lond) 2010; 118 Pt 9; 547-64
10. Broker M, Jacobsson S, Detora L, et al. Increase of meningococcal serogroup Y cases in Europe; a reason for concern? Hum Vaccin Immunother 2012 May; 8 (5); 685-8
11. Marc LaForce F, Ravenscroft N, Djingarey M, et al. Epidemic meningitis due to Group A Neisseria meningitidis in the African meningitis belt; a persistent problem with an imminent solution. Vaccine 2009 Jun 24; 27 Suppl. 2; B13-9
12. Boisier P, Nicolas P, Djibo S, et al. Meningococcal meningitis; unprecedented incidence of serogroup X-related cases in 2006 in Niger. Clin Infect Dis 2007 Mar 1; 44 (5); 657-63
13. Lingappa JR, Al-Rabeah AM, Hajjeh R, et al. Serogroup W-135 meningococcal disease during the Hajj, 2000. Emerg Infect Dis 2003 Jun; 9 (6); 665-71
14. Choudhuri D, Huda T, Theodoratou E, et al. An evaluation of emerging vaccines for childhood meningococcal disease. BMC Public Health 2011; 11 Suppl. 3; S29
15. Stephens DS. Conquering the meningococcus. FEMS Microbiol Rev 2007 Jan; 31 (1); 3-14
16. Harrison LH. Prospects for vaccine prevention of meningococcal infection. Clin Microbiol Rev 2006 Jan; 19 (1); 142-64
17. Broker M, Dull PM, Rappuoli R, et al. Chemistry of a new investigational quadrivalent meningococcal conjugate vaccine that is immunogenic at all ages. Vaccine 2009; 27 (41); 5574-80
18. Papaevangelou V, Spyridis N. MenACWY-TT vaccine for active immunization against invasive meningococcal disease. Expert Rev Vaccines 2012 May; 11 (5); 523-37
19. Advisory Committee on Immunization Practices. Updated recommendation from the Advisory Committee on Immunization Practices (ACIP) for reactivation of persons at prolonged increased risk for meningococcal disease. MMWR Morb Mortal Wkly Rep 2009 Sep 25; 58 (37); 1042-3.
20. Deeks ED. Meningococcal quadrivalent (serogroups A, C, W135, and Y) conjugate vaccine (Menveo®); in adolescents and adults. BioDrugs 2010; 24 (5); 287-97
21. Sanofi Pasteur Inc. Menactra® (meningococcal. groups A, C, Y and W-135. polysaccharide diphtheria toxoid conjugate vaccine); US prescribing information. online. Available from URL; :http://www.fda.gov/downloads/ biologicsbloodvaccines/vaccines/approvedproducts/ucm131170.pdf. Accessed 2012 Jul 30.
22. Novartis AG. Menveo® (meningococcal. groups A, C, Y and W-135. oligosaccharide diphtheria CRM197 conjugate vaccine); US prescribing information. online. Available from URL; :http://www.fda.gov/downloads/ biologicsbloodvaccines/vaccines/approvedproducts/ucm201349.pdf. Accessed 2012 Jul 30.
23. European Medicines Agency. Menveo (meningococcal. group A, C, W135 and Y. conjugate vaccine); summary of product characteristics. online. Available from URL; :http://www.emea.europa.eu/docs/en-GB/document-library/EPAR-Product- Information/human/001095/WC500090147.pdf. Accessed 2012 Jul 30.
24. European Medicines Agency. Menveo; summary of opinion (post authorisation). online. Available from URL; :http://www.ema.europa.eu/docs/en- GB/document-library/Summary-of-opinion/human/001095/WC500124220.pdf. Accessed 2012 Nov 11.
25. European Medicines Agency. Meningococcal group A, C, W-135 and Y conjugate vaccine Nimenrix; summary of product characteristics. online. Available from URL; :http://www.europa.eu. Accessed 2012 May 25.
26. GlaxoSmithKline. GlaxoSmithKline receives European authorisation for Nimenrix™ (meningococcal group A, C, W-135 and Y conjugate vaccine). media release. 2012 Apr 27. online. Available from URL; :http://www.gsk.com/media/ press-releases/2012/glaxosmithkline-receives-european-authorisation-for- nimenrix-meningococcal-group-a-c-w-135-and-y-conjugate-vaccine.html
27. Knuf M, Kieninger-Baum D, Habermehl P, et al. A dose-range study assessing immunogenicity and safety of one dose of a new candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered in the second year of life and in young children. Vaccine 2010; 28 (3); 744-53
28. Ostergaard L, Lebacq E, Poolman J, et al. Immunogenicity, reactogenicity and persistence of meningococcal A, C, W-135 and Y-tetanus toxoid candidate conjugate (MenACWY-TT) vaccine formulations in adolescents aged 15-25 years. published erratum appears in Vaccine 2009; 27 (52); 7467.
29. Ostergaard L, Lebacq E, Poolman J, et al. Immunogenicity, reactogenicity and persistence of meningococcal A, C, W-135 and Y-tetanus toxoid candidate conjugate (MenACWY-TT) vaccine formulations in adolescents aged 15-25 years. Vaccine 2009; 27 (1); 161-8
30. Baxter R, Baine Y, Ensor K, et al. 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. Pediatr Infect Dis J 2011; 30 (3); e41-8
31. Vesikari T, Forsten A, Boutriau D, et al. A randomized study to assess the immunogenicity, antibody persistence and safety of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in children aged 2-10 ay. Hum Vaccin Immunother. Epub 2012 Oct 2
32. Borja-Tabora C, Montalban C, Memish Z, et al. Immunogenicity of one dose of an investigational meningococcal tetravalent tetanus-toxoid conjugate (MENACWY-TT) vaccine in 11-17 year olds. abstract no. 568. 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID); 2009 Nov 19-22; Buenos Aires
33. Memish ZA, Dbaibo G, Montellano M, et al. Immunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135, and Y conjugate vaccine administered to 2-to 10-year-olds is noninferior to a licensed-ACWY polysaccharide vaccine with an acceptable safety profile. Pediatr Infect Dis J 2011; 30 (4); e56-62
34. Vesikari T, Karvonen A, Bianco V, et al. Tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine is well tolerated and immunogenic when co-administered with measles-mumps-rubella-varicella vaccine during the second year of life; an open, randomized controlled trial. Vaccine 2011; 29 (25); 4274-84
35. Ostergaard L, Silfverdal S-A, Berglund J, et al. A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix in individuals aged 11-17 years; an open, randomised, controlled trial. Vaccine 2012; 30 (4); 774-83
36. Knuf M, Pantazi-Chatzikonstantinou A, Pfletschinger U, et al. An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children. Vaccine 2011; 29 (25); 4264-73
37. Dbaibo G, Macalalad N, Reyes MR, et al. The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine; a randomized, controlled non-inferiority study. Hum Vaccin Immunother 2012 Jul 1; 8 (7); 873-80
38. Reyes MR, Dimaano E, Macalalad N, et al. The investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) and the seasonal influenza virus vaccine are immunogenic and well-tolerated when co-administered in adults. Hum Vaccin Immunother 2012 Jul 1; 8 (7); 881-7
39. Bermal N, Huang L-M, Dubey AP, et al. Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults. Hum Vaccines 2011; 7 (2); 239-47
40. Dbaibo G, Van der Wielen M, Reda M, et al. The tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic with a clinically acceptable safety profile in individuals previously vaccinated with a tetravalent polysaccharide vaccine. Int J Infect Dis 2012 Aug; 16 (8); e608-15
41. Vesikari T, Forsten A, Boutriau D, et al. Randomized trial to assess the immunogenicity, safety and antibody persistence up to three years after a single dose of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlers. Human Vaccin Immunother. Epub 2012 Oct 2
42. Klein NP, Baine Y, Bianco V, et al. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy toddlers; 1-year persistence. abstract no. G1-753. 51st International Conference on Antimicrobial Agents and Chemotherapy; 2011 Sep 17-20; Chicago (IL
43. Borja-Tabora C, Montalban C, Memish Z, et al. Persistence of immune response up to 3 years following vaccination with MenACWY-TT meningococcal vaccine in individuals aged 11-55 years. abstract. 4th Northern European Conference on Travel Medicine; 2012 Jun 6-8; Dublin
44. Ostergaard L, Bianco V, Van Der Wielen M, et al. Persistence of immune response to candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid-conjugated vaccine (MenACWY-TT) up to 42 months following primary vaacination. abstract no. 530. 3rd Congress of the European Academy of Paediatric Sciences; 2010 Oct 23-26; Copenhagen
45. Baxter R, Baine Y, Ensor K, et al. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults; 1-year persistence. abstract no. G1-754. 51st International Conference on Antimicrobial Agents and Chemotherapy; 2011 Sep 17-20; Chicago (IL)
46. Knuf M, Baine Y, Bianco V, et al. Antibody persistence and immune memory 15 months after priming with an investigational tetravalent meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) in toddlers and young children. Hum Vaccin Immunother 2012 Jul; 8 (7); 866-72
47. Vesikari T, Forsten A, Bianco V, et al. Persistence of immune response to a candidate meningococcal tetravalent tetanus toxoid-conjugate vaccine (MENACWY-TT) in toddlers, 2 years after vaccination. abstract. 30th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2012 May 8-12; Thessaloniki
48. Quiambao BP, Jain H, Bavdekar A, et al. Persistence of immune response to a candidate meningococcal tetravalent tetanus toxoid-conjugate vaccine (MenACWY-TT) in healthy Asian adolescents, 2-years after vaccination. abstract. 30th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2012 May 8-12; Thessaloniki
49. Ruiz-Palacios GM, Huang LM, Lin TY, et al. Immunogenicity and safety of a booster dose of the 10-valent pneumococcal haemophilus influenzae protein D conjugate vaccine co-administered with the tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine in toddlers; a randomized trial. Pediatr Infect Dis J. Epub 2012 Oct 16
50. Nauta JJ, de Bruijn IA. The European CHMP criteria for influenza vaccine immunogenicity cannot be improved by the use of confidence intervals. Vaccine 2006 Nov 10; 24 (44-46); 6643-4
51. Borrow R, Andrews N, Goldblatt D, et al. Serological basis for use of meningococcal serogroup C conjugate vaccines in the United Kingdom; reevaluation of correlates of protection. Infect Immun 2001 Mar; 69 (3); 1568-73
52. Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med 1969 Jun 1; 129 (6); 1307-26
53. GlaxoSmithKline. Lot-to-lot consistency, non-inferiority versus Mencevax™ and evaluation of the co-administration with Fluarix™ of GSK Biologicals meningococcal vaccine GSK134612, in healthy subjects aged 18 through 55 years of age (study no. 109067). online. Available from URL; :www.gsk-clinicalstudyregister.com. Accessed 2012 Nov 13.
54. GlaxoSmithKline. Persistence of antibodies after GSK Biologicals, meningococcal vaccine GSK134612 in toddlers (study no.112036). online. Available from URL; :www.gsk-clinicalstudyregister.com. Accessed 2012 Jun 21.
55. GlaxoSmithKline. A phase II, open (partially double-blind), randomized, controlled dose-range study to evaluate the immunogenicity, reactogenicity and safety of four different formulations of GlaxoSmithKline (GSK) Biologicals, new generations meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine versus MENINGITEC™ or MENCEVAX™ ACWY when given as one dose to children aged 12 to 14 months and 3 to 5 years old (study no. 104703 and 104704). online. Available from URL; :www.gsk-clinicalstudyregister. com. Accessed 2012 Jun 21.
56. GlaxoSmithKline. Persistence of antibodies after vaccination with GSK Biologicals, meningococcal vaccine GSK134612 in adolescents and young adults (study no. 112148). online. Available from URL; :www.gsk-clinicalstudyregister. com. Accessed 2012 Jun 22.
57. Bilukha OO, Rosenstein N. Prevention and control of meningococcal disease; recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2005 May 27; 54 (RR07); 1-21
58. Rosenstein NE, Perkins BA, Stephens DS, et al. Meningococcal disease. N Engl J Med 2001 May 3; 344 (18); 1378-88
59. Reisinger K, Black S, Stoddard J. Optimizing protection against meningococcal disease. Clin Pediatr (Phila) 2010; 49 (6); 586-97
60. Tan L, Carlone G, Borrow R. Advances in the development of vaccines against Neisseria meningitidis. N Engl J Med 2010; 362 (16); 1511-20
61. Teyssou R, Muros-Le Rouzic E. Meningitis epidemics in Africa; a brief overview. Vaccine 2007 Sep 3; 25 Suppl. 1; A3-7
62. Cohn AC, MacNeil JR, Harrison LH, et al. Changes in Neisseria meningitidis disease epidemiology in the United States, 1998-2007; implications for prevention of meningococcal disease. Clin Infect Dis 2010 Jan 15; 50 (2); 184-91
63. Kriz P, Wieffer H, Holl K, et al. Changing epidemiology of meningococcal disease in Europe from the mid-20th to the early 21st Century. Expert Rev Vaccines 2011; 10 (10); 1477-86
64. Karve S, Misurski D, Miller J, et al. Long-term economic and clinical burden of complicated invasive meningococcal disease; evidence from a United States managed care population. abstract no. PIN13. ISPOR 13th Annual European Congress; 2010 Nov 6-9; Prague
65. Davis KL, Misurski D, Miller J, et al. Cost impact of complications in meningococcal disease; evidence from a United States managed care population. Hum Vaccin 2011 Apr; 7 (4); 458-65
66. Trotter C, Andrews N, Kaczmarski E, et al. Effectiveness of meningococcal serogroup C conjugate vaccine four years after introduction. Lancet 2004 Jul 24-30; 364 (9431); 365-7
67. Campbell H, Andrews N, Borrow R, et al. Updated postlicensure surveillance of the meningococcal C conjugate vaccine in England and Wales; effectiveness, validation of serological correlates of protection, and modeling predictions of the duration of herd immunity. Clin Vaccine Immunol May; 17 (5); 840-7
68. Trotter CL, Maiden MC. Meningococcal vaccines and herd immunity; lessons learned from serogroup C conjugate vaccination programs. Expert Rev Vaccines 2009 Jul; 8 (7); 851-61
69. Pfizer Limited. Meningitec; summary of product characteristics. online. Available from URL; :http://www.medicines.org.uk/EMC/medicine/20747/SPC/ Meningitec+in+pre-filled+syringe/#INDICATIONS. Accessed 2012 Sep 27.
70. Meningitis vaccine project. Vaccine introduction strategy. online. Available from URL; :http://www.meningvax.org/vaccine-introduction.php. Accessed 2012 Sep 27.
71. Centers for Disease Control and Prevention. Updated recommendations for use of meningococcal conjugate vaccines; Advisory Committee on Immunization Practices (ACIP), 2010. JAMA 2011 Apr 6; 305 (13); 1291-3.
72. McVernon J, Nolan T, Richmond P, et al. A randomized trial to assess safety and immunogenicity of alternative formulations of a quadrivalent meningococcal (A, C, Y, and W-135) tetanus protein conjugate vaccine in toddlers. Pediatr Infect Dis J 2012; 31 (1); e15-23
73. Auckland C, Gray S, Borrow R, et al. Clinical and immunologic risk factors for meningococcal C conjugate vaccine failure in the United Kingdom. J Infect Dis 2006 Dec 15; 194 (12); 1745-52
74. Gill CJ, Baxter R, Anemona A, et al. Persistence of immune responses after a single dose of Novartis meningococcal serogroup A, C, W-135 and Y CRM-197 conjugate vaccine (Menveo®) or Menactra® among healthy adolescents. Hum Vaccin 2010 Nov; 6 (11); 881-7