Immunogenicity and safety of the quadrivalent meningococcal serogroups A, C, W-135 and y tetanus toxoid conjugate vaccine (MenACWY-TT) in 2-10-year-old children: Results of an open, randomised, controlled study

European Journal of Pediatrics

Volumn 172, Issue 5, 2013, Pages 601-612

  Knuf, Markus ^a   Romain, Olivier ^b   Kindler, Klaus ^c   Walther, Uta ^d   Tran, Phu My ^e   Pankow Culot, Heidemarie ^f   Fischbach, Thomas ^g   Kieninger Baum, Dorothee ^a   Bianco, Véronique ^h   Baine, Yaela ⁱ   Miller, Jacqueline ⁱ  

^a JOHANNES GUTENBERG UNIVERSITY   (Germany)

^b HÔPITAL ANTOINE BÉCLÈRE   (France)

^c not available   (Germany)

^d not available   (Germany)

^e not available   (France)

^f not available   (Germany)

^g not available   (Germany)

^h GSK   (Belgium)

ⁱ GLAXOSMITHKLINE   (United States)

Author keywords

Bactericidal activity; Child; Conjugate vaccine; Quadrivalent meningococcal vaccine; Randomised trial; Tetanus toxoid

Indexed keywords

DIPHTHERIA TOXOID CRM197; MENINGOCOCCAL SEROGROUP A C Y W 135 TETANUS TOXOID CONJUGATE VACCINE; MENINGOCOCCUS VACCINE; TETANUS TOXOID; UNCLASSIFIED DRUG;

ARTICLE; CHILD; CHRONIC OTITIS MEDIA; CONTROLLED STUDY; COUGHING; DERMATITIS; DROWSINESS; DRUG ERUPTION; DRUG SAFETY; ECZEMA; ENDEMIC DISEASE; FEMALE; FEVER; FOLLOW UP; GASTROESOPHAGEAL REFLUX; HUMAN; IMMUNIZATION; IMMUNOGENICITY; IRRITABILITY; MAJOR CLINICAL STUDY; MALE; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SCHOOL CHILD; SERUM BACTERICIDAL ACTIVITY; SIDE EFFECT; SINGLE DRUG DOSE; SKIN EXFOLIATION; URTICARIA;

CHILD; CHILD, PRESCHOOL; FEMALE; FRANCE; GERMANY; HUMANS; MALE; MENINGOCOCCAL INFECTIONS; MENINGOCOCCAL VACCINES; NEISSERIA MENINGITIDIS;

EID: 84876665145     PISSN: 03406199     EISSN: 14321076     Source Type: Journal    
DOI: 10.1007/s00431-012-1924-0     Document Type: Article

References (59)

1. Andrews N, Borrow R, Miller E (2003) Validation of serological correlate of protection for meningococcal C conjugate vaccine by using efficacy estimates from postlicensure surveillance in England. Clin Diagn Lab Immunol 10:780-786
2. Antignac A, Ducos-Galand M, Guiyoule A, Pirès R, Alonso J-M, Taha M-K (2003) Neisseria meningitidis strains isolated from invasive infections in France (1999-2002): phenotypes and antibiotic susceptibility patterns. Clin Infect Dis 37:912-920
3. Auckland C, Gray S, Borrow R, Andrews N, Goldblatt D, Ramsay M, Miller E (2006) Clinical and immunological risk factors for meningococcal C conjugate vaccine failure in the United Kingdom. J Infect Dis 194:1745-1752
4. Bermal N, Huang L-M, Dubey AP, Jain H, Bavdekar A, Lin T-Y, Bianco V, Baine Y, Miller JM (2011) Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults. Hum Vaccin 7:239-247
5. Bettinger JA, Scheifele DW, Le Saux N, Halperin SA, Vaudry W, Tsang R (2009) The impact of childhood meningococcal serogroup C conjugate vaccine programs in Canada. Pediatr Infect Dis J 28:220-224
6. Bidmos FA, Neal KR, Oldfield NJ, Turner DP, Ala'aldeen DA, Bayliss CD (2011) Persistence, replacement, and rapid clonal expansion of meningococcal carriage isolates in a 2008 university student cohort. J Clin Microbiol 49:506-512
7. Black S, Klein NP, Shah J, Bedell L, Karsten A, Dull PM (2010) Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age. Vaccine 28:657-663
8. Borrow R, Andrews N, Goldblatt D, Miller E (2001) Serological basis for use of meningococcal serogroup C conjugate vaccines in the United Kingdom: reevaluation of correlates of protection. Infect Immun 69:1568-1573
9. Borrow R, Balmer P, Miller E (2005) Meningococcal surrogates of protection-serum bactericidal antibody activity. Vaccine 23:2222-2227
10. Borrow R, Miller E (2006) Long-term protection in children with meningococcal C conjugate vaccination: lessons learned. Expert Rev Vaccines 5:851-857
11. Bryant KA, Marshall GS, Marchant CD, Pavia-Ruiz N, Nolan T, Rinderknecht S, Blatter M, Aris E, Lestrate P, Boutriau D, Friedland LR, Miller JM (2011) Immunogenicity and safety of H influenzae type b-N meningitidis C/Y conjugate vaccine in infants. Pediatrics 127:e1375-e1385
12. Centers for Disease Control and Prevention (2006) Inadvertent misadministration of meningococcal conjugate vaccine-United States, June-August 2005. MMWR Morb Mortal Wkly Rep 55:1016-1017
13. de Voer RM, Mollema L, Schepp RM, de Greeff SC, van Gageldonk PG, deMelker HE, Sanders EA, Berbers GA, van der Klis FR (2010) Immunity against Neisseria meningitidis serogroup C in the Dutch population before and after introduction of the meningococcal C conjugate vaccine. PLoS One 5:e12144
14. De Wals P, Deceuninck G, Lefebvre B, Boulianne N, De Serres G (2011) Effectiveness of serogroup C meningococcal conjugate vaccine: a 7-year follow-up in Quebec, Canada. Pediatr Infect Dis J 30:566-569
15. European Centre for Disease Prevention and Control (2012). Summary chart, vaccination schedule for France. http://ecdc.europa.eu/en/activities/ surveillance/euvac/schedules/Pages/france.aspx. Accessed 21 Nov 2012
16. European Medicines Agency (2012).Assessment report Nimenrix. Procedure N0. EMAE/H/C/002226. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR- Public-assessment-report/human/002226/WC500127664.pdf. Accessed 20 July 2012)
17. European Union Invasive Bacterial Infections Surveillance (EU-IBIS) Network (2007) Invasive Neisseria meningitis in Europe 2006. Health Protection Agency, London 2006. http://www.hpa-bioinformatics.org.uk/euibis/documents/2006- meningo.pdf. Accessed 02 Apr 2012
18. Findlow J, Balmer P, Yero D, Niebla O, Pajón R, Borrow R (2007) Neisseria vaccines 2007. Expert Rev Vaccines 6:485-489
19. Gold R, Lepow ML, Goldschneider I, Draper TF, Gotshlich EC (1979) Kinetics of antibody production to group A and group C meningococcal polysaccharide vaccines administered during the first six years of life: prospects for routine immunization of infants and children. J Infect Dis 140:690-697
20. Goldschneider I, Gotschlich EC, Artenstein MS (1969) Human immunity to the meningococcus. J Exp Med 129:1307-1326
21. Granoff DM (2009) Relative importance of complement-mediated bactericidal and opsonic activity for protection against meningo-coccal disease. Vaccine 27:B117-B125
22. Gray SJ, Trotter CL, Ramsay ME, Guiver M, Fox AJ, Borrow R, Mallard RH, Kaczmarski EB (2006) Epidemiology of meningo-coccal disease in England and Wales 1993/94 to 2003/04: contribution and experiences of meningococcal reference unit. J Med Microbiol 55:887-896
23. Harrison LH (2006) Prospects for vaccine prevention of meningo-coccal infection. Clin Microbiol Rev 19:142-164
24. Harrison LH, Trotter CL, Ramsay ME (2009) Global epidemiology of meningococcal disease. Vaccine 27:B51-B63
25. Hassan-King MK, Wall RA, Greenwood BM (1988) Meningococcal carriage, meningococcal disease and vaccination. J Infect 16:55-59
26. Hellenbrand W, Elias J, Wichmann O, Dehnert M, Frosch M, Vogel U (2012) Epidemiology of invasive meningococcal disease in Germany, 2002-2010, and impact of vaccination with meningococcal C conjugate vaccine. J Infect. doi:10.1016/j.jinf.2012.09.008
27. Jackson LA, Baxter R, Reisinger K, Karsten A, Shah J, Bedell L, Dull PM (2009) Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed me-ningococcal ACWY conjugate vaccine in adolescents. Clin Infect Dis 49:e1-e10
28. Jodar L, Cartwright K, Feavers IM (2000) Standardisation and validation of serological assays for the evaluation of immune responses to Neisseria meningitidis serogroup A and C vaccines. Biologicals 28:193-197
29. Kaaijk P, van der Ende A, Berbers G, van den Dobbelsteen GP, Rots NY (2012) Is a single dose of meningococcal serogroups C conjugate vaccine sufficient for protection? Experience from the Netherlands. BMC Infect Dis 12:35. doi:10.1186/1471-2334-12-35
30. Keyserling H, Papa T, Koranyi K, Ryall R, Bassily E, Bybel MJ, Sullivan K, Gilmet G, Reinhardt A (2005) Safety, immunogenicity, and immune memory ofa novel meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4) in healthy adolescents. Arch Pediatr Adolesc Med 159:907-913
31. Kinlin LM, Jamieson F, Brown EM, Brown S, Rawte P, Dolman S, Drews SJ, Fisman DN (2009) Rapid identification of herd effects with the introduction of serogroup C meningococcal conjugate vaccine in Ontario, Canada, 2000-2006. Vaccine 27:1735-1740
32. Knuf M, Kieninger-Baum D, Habermehl P, Muttonen P, Maurer H, Vink P, Poolman J, Boutriau D (2010) 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 28:744-753
33. Larrauri A, Cano R, Garcia M, Mateo S (2005) Impact and effectiveness of meningococcal C conjugate vaccine following its introduction in Spain. Vaccine 23:4097-4100
34. MacDonald NE, Halperin SA, Law BJ, Forrest B, Danzig LE, Granoff DM (1998) Induction of immunologic memory by conjugated vs plain meningococcal C polysaccharide vaccine in toddlers: a randomized controlled trial. JAMA 280:1685-1689
35. Maiden MC, Ibarz-Pavon AB, Urwin R, Gray SJ, Andrews NJ, Clarke SC, Walker AM, Evans MR, Kroll JS, Neal KR et al (2008) Impact of meningococcal serogroup C conjugate vaccines on carriage and herd immunity. J Infect Dis 197:737-743
36. Maslanka SE, Gheesling LL, Libutti DE, Donaldson KB, Harakeh HS, Dykes JK, Arhin FF, Devi SJ, Frasch CE, Huang JC et al (1997) Standardization and a multilaboratory comparison of Neisseria meningitidis serogroup A and C serum bactericidal assays. Clin Diagn Lab Immunol 4:156-167
37. Memish ZA, Dbaibo G, Montellano M, Verghese VP, Jain H, Dubey AP, Bianco V, Van der Wielen M, Gatchalian S, Miller JM (2011) Immuno-genicity 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 30:e56-e62
38. Morley SL, Pollard AJ (2001) Vaccine prevention of meningococ-cal disease, coming soon? Vaccine 20:666-687
39. Parent du Châtelet I, Barboza P, Taha MK (2012) W135 invasive meningococcal infections imported from Sub-Saharan Africa to France, January to April 2012. Eur Surveill 17(21) pii=20181
40. Pichichero M, Casey J, Blatter M, Rothstein E, Ryall R, Bybel M, Gilemt G, Papa T (2005) Comparative trial of the safety and immunogenicity of quadrivalent (A, C, Y, W-135) meningococcal polysaccharide-diphtheria conjugate vaccine versus quadrivalent polysaccharide vaccine in two-to ten-year-old children. Pediatr Infect Dis J 24:57-62
41. Pollard AJ (2004) Global epidemiology of meningococcal disease and vaccine efficacy. Pediatr Infect Dis J 23:S274-S279
42. Pollard AJ, Perrett KP, Beverley PC (2009) Maintaining protection against invasive bacteria with protein-polysaccharide conjugate vaccines. Nat Rev Immunol 9:213-220
43. Ramsay ME, Andrews N, Kaczmarski EB, Miller E (2001) Efficacy of meningococcal serogroup C conjugate vaccine in teenagers and toddlers in England. Lancet 357:195-196
44. Richmond P, Borrow R, Goldblatt D, Findlow J, Martin S, Morris R, Cartwright K, Miller E (2001) Ability of 3 different meningo-coccal C conjugate vaccines to induce immunologic memory after a single dose in UK toddlers. J Infect Dis 183:160-163
45. Slinko VG, Sweeny A (2007) Reduction of invasive meningococ-cal disease in Queensland: a success for immunisation. Commun Dis Intell 31:227-232
46. Snape MD, Perrett KP, Ford KJ, John TM, Pace D, Yu LM, Langley JM, McNeil S, Dull PM, Ceddia F et al (2008) Immuno-genicity of a tetravalent meningococcal glycoconjugate vaccine in infants: a randomized controlled trial. JAMA 299:173-184
47. Southern J, Borrow R, Andrews N, Morris R, Waight P, Hudson M, Balmer P, Findlow H, Findlow J, Miller E (2009) Immunogenicity of a reduced schedule of meningococcal group C conjugate vaccine given concomitantly with the Prevenar and Pediacel vaccines in healthy infants in the United Kingdom. Clin Diagn Lab Immunol 16:194-199
48. Sow SO, Okoko BJ, Diallo A, Viviani S, Borrow R, Carlone G, Tapia M, Akinsola AK, Arduin P, Findlow H et al (2011) Immu-nogenicity and safety of a meningococcal A conjugate vaccine in Africans. N Engl J Med 364:2293-2304
49. Stephens DS (2007) Conquering the meningococcus. FEMS Microbiol Rev 31:3-14
50. Tan LK, Carlone GM, Borrow R (2010) Advances in the development of vaccines against Neisseria meningitidis. N Engl J Med 362:1511-1520
51. The European Meningococcal Disease Society (EMGM). 11th EMGM Meeting, May 18-20, 2011, Ljubljana, Slovenia. Poster abstracts: Emergence of serogroup Y: P035-040
52. Thulin HS, Toros B, Fredlund H, Olcen P, Molling P (2011) Genetic characterisation of the emerging invasive Neisseria men-ingitidis serogroup Y in Sweden, 2000 to 2010. Euro Surveill 16
53. Trotter CL, Andrews NJ, Kaczmarski EB, Miller E, Ramsay ME (2004) Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet 364:365-367
54. Trotter CL, Chandra M, Cano R, Larrauri A, Ramsay ME, Brehony C, Jolley KA, Maiden MC, Heuberger S, Frosch M (2007) A surveillance network for meningococcal disease in Europe. FEMS Microbiol Rev 31:27-36
55. Tsolia MN, Theodoridou M, Tzanakaki G, Vlachou V, Mostrou G, Stripeli F, Kalabalikis P, Pangalis A, Kafetzis D, Kremastinou J, Konstantopoulos A (2006) Invasive meningococcal disease in children in Greece: comparison of serogroup A disease with disease caused by other serogroups. Eur J Clin Microbiol Infect Dis 25:449-456
56. US Food and Drug Administration (2011) Approval letter-Men-actra. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm252511. htm. Accessed 30 Mar 2012
57. US Food and Drug Administration (2011) Menveo; Full prescribing information. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ ApprovedProducts/ucm201342.htm.Accessed 19 July 2012
58. Vesikari T, Karvonen A, Bianco V, Van der Wielen M, Miller J (2011) 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. Vaccine 29:4274-4284
59. World Health Organization (2006) Recommendations to assure the quality, safety and efficacy of group A meningococcal conjugate vaccines. Geneva, Switzerland: WHO Press; Report No: WHO/BS/06.2041