Comparison of the safety and immunogenicity of a novel quadrivalent meningococcal ACWY-Tetanus toxoid conjugate vaccine and a marketed quadrivalent meningococcal ACWY-Diphtheria toxoid conjugate vaccine in healthy individuals 10-25 years of age

Journal of the Pediatric Infectious Diseases Society

Volumn 3, Issue 1, 2014, Pages 33-42

  Halperin, Scott A ^a   Baine, Yaela ^b   Domachowske, Joseph B ^c   Aggarwal, Naresh ^d   Simon, Michael ^e   Langley, Joanne M ^a   McNeil, Shelly A ^a   Friedland, Leonard R ^b   Bianco, Veronique ^f   Baccarini, Carmen I ^b   Miller, Jacqueline M ^b  

^a DALHOUSIE UNIVERSITY   (Canada)

^b GLAXOSMITHKLINE   (United States)

^c SUNY UPSTATE MEDICAL UNIVERSITY   (United States)

^d Findagate Medical Centre   (Canada)

^e Pediatric and Adolescent Medicine   (United States)

^f GSK   (Belgium)

Author keywords

Meningococcal conjugate vaccine; Neisseria meningitidis; Vaccine immunogenicity; Vaccine safety

Indexed keywords

DIPHTHERIA TOXOID; MENINGOCOCCUS VACCINE; TETANUS TOXOID;

ADOLESCENT; ADULT; ANTIBODY RESPONSE; ARTICLE; CHILD; CONTROLLED STUDY; DRUG RESPONSE; FATIGUE; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INJECTION SITE REACTION; INJECTION SITE SWELLING; MALE; MENINGOCOCCOSIS; MULTICENTER STUDY; NONHUMAN; NORMAL HUMAN; PAIN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SERUM BACTERICIDAL ANTIBODY ASSAY; SINGLE BLIND PROCEDURE; SINGLE DRUG DOSE; SKIN REDNESS; VACCINATION REACTION;

EID: 84923282052     PISSN: 20487193     EISSN: 20487207     Source Type: Journal    
DOI: 10.1093/jpids/pit058     Document Type: Article

References (34)

1. Harrison LH, Trotter CL, Ramsay ME. Global epidemiology of meningococcal disease. Vaccine 2009; 275:B51-63.
2. Rosenstein NE, Perkins BA, Stephens DS, et al. Meningococcal disease. N Engl J Med 2001; 344:1378-88.
3. Harrison LH. Prospects for vaccine prevention of meningococcal infection. Clin Microbiol Rev 2006; 19:142-64.
4. Halperin SA, Bettinger JA, Greenwood B, et al. The changing and dynamic epidemiology of meningococcal disease. Vaccine 2012; 30(Suppl 2):B26-36.
5. NNDSS Annual Report Writing Group. Australia's notifiable disease status, 2008: Annual report of the National Notifiable Diseases Surveillance System. Commun Dis Intell 2010; 34: 214-6.
6. Trotter C, Gay N, EdmundsW. Dynamic models of meningococcal carriage and the impact of serogroup C conjugate vaccination. Am J Epidemiol 2005; 162:89-100.
7. de Greeff SC, de Melker HE, Spanjaard L, et al. Protection from routine vaccination at the age of 14 months with meningococcal serogroup C conjugate vaccine in the Netherlands. Pediatr Infect Dis J 2006; 25:79-80.
8. De Wals P, Deceuninck G, Lefebvre B, et al. Effectiveness of serogroup C meningococcal conjugate vaccine. A 7-year follow-up in Quebec, Canada. Pediatr Infect Dis J 2011; 30: 566-9.
9. Bettinger JA, Scheifele DW, Le Saux N, et al. The impact of childhood meningococcal serogroup C conjugate vaccine programs in Canada. Pediatr Infect Dis J 2009; 28:220-4.
10. Centers for Disease Control and Prevention (CDC). Updated recommendations for use of meningococcal conjugate vaccines-Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep 2011; 60: 72-76.
11. Canadian Immunization Committee and Public Health Agency of Canada. Advice for consideration of quadrivalent (A, C, Y, W135) meningococcal conjugate vaccine, for use by provinces and territories. Can Commun Dis Rep 2010; 36(Suppl 2):1-36.
12. Granoff DM. Review of meningococcal group B vaccines. Clin Infect Dis 2010; 50(Suppl 2):S54-65.
13. Serruto D, Bottomley MJ, Ram S, et al. The new multicomponent vaccine against meningococcal serogroup B, 4CMenB: immunological, functional and structural characterization of the antigens. Vaccine 2012; 30(Suppl 2):B87-97.
14. Richmond PC, Marshall HS, Nissen MD, et al. Safety, immunogenicity, and tolerability of meningococcal serogroup B bivalent recombinant lipoprotein 2086 vaccine in healthy adolescents: a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis 2012; 12:597-607.
15. 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: 161-8.
16. 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: 744-53.
17. 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: 4264-73.
18. Bermal N, Huang LM, 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 Vaccin 2011; 7:239-47.
19. Østergaard L, Silfverdal SA, 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 subjects aged 11-17 years: An open, randomised, controlled trial. Vaccine 2012; 30: 774-83.
20. 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: e41-8.
21. 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: e56-62.
22. 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-mumpsrubella-varicella vaccine during the second year of life: an open, randomized controlled trial. Vaccine 2011; 29:4274-84.
23. Berry DS, Lynn F, Lee CH, et al. Effect of O acetylation of Neisseria meningitidis serogroup A capsular polysaccharide on development of functional immune responses. Infect Immun 2002; 70:3707-13.
24. Maslanka SE, Gheesling LL, Libutti DE, et al. Standardization and a multilaboratory comparison of Neisseria meningitidis serogroup A and C serum bactericidal assays. The Multilaboratory Study Group. Clin Diagn Lab Immunol 1997; 4:156-67.
25. Jennings H, Bhattacharjee A, Bundle D, et al. Structure of the capsular polysaccharide of Neisseria meningitidis as determined by 13C-nuclear magnetic resonance spectroscopy. J Infect Dis 1977; 136:S78-83.
26. 1H NMR assignment and detailed O-acetylation patterns of capsular polysaccharides used in vaccine production. Carbohydr Res 1996; 296:83-96.
27. Jackson LA, Baxter R, Reisinger K, et al. Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. Clin Infect Dis 2009; 49:e1-10.
28. Centers for Disease Control and Prevention (CDC). Revised recommendations of the Advisory Committee on Immunization Practices to vaccinate all persons aged 11-18 years with meningococcal conjugate vaccine. MMWR Morb Mortal Wkly Rep 2007; 56:794-5.
29. Centers for Disease Control and Prevention (CDC). Report from the Advisory Committee on Immunization Practices (ACIP): Decision not to recommend routine immunization of all children aged 2-10 years with quadrivalent meningococcal conjugate vaccine (MCV4). MMWR Morb Mortal Wkly Rep 2008; 57: 462-5.
30. Centers for Disease Control and Prevention (CDC). Notice to readers: recommendations from the Advisory Committee on Immunization Practices (ACIP) for use of quadrivalent meningococcal conjugate vaccine (MCV4) in children aged 2-10 years at increased risk for invasive meninogocccal disease. MMWR Morb Mortal Wkly Rep 2007; 56:1265-6.
31. Centers for Disease Control and Prevention (CDC). General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2011; 60:1-61.
32. Centers for Disease Control and Prevention (CDC). Recommendation of the Advisory Committee on Immunization Practices (ACIP) for use of quadrivalent meningococcal conjugate vaccine (MenACWY-D) among children aged 9 through 23 months at increased risk for invasive meningococcal disease. MMWRMorb Mortal Wkly Rep 2011; 60:1391-2.
33. Public Health Agency of Canada. Publicly funded immunization programs in Canada-Routine schedule for infants and children including special programs and catch-up programs. Available at: http://www.phac-aspc.gc.ca/im/ptimprog-progimpt/table-1-eng. php. Accessed 6 October 2012.
34. Trotter CL, Ramsay ME. Vaccination against meningococcal disease in Europe: review and recommendations for the use of conjugate vaccines. FEMS Microbiol Rev 2007; 31:101-7.