Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants

Pediatric Infectious Disease Journal

Volumn 31, Issue 1, 2012, Pages 64-74

  Klein, Nicola P ^a   Reisinger, Keith S ^b   Johnston, William ^c   Odrljin, Tatjana ^d   Gill, Christopher J ^e   Bedell, Lisa ^f   Dull, Peter ^d  

^a KAISER PERMANENTE   (United States)

^b Primary Physicians Research   (United States)

^c Alabama Clinical Therapeutics   (United States)

^d Biostatistics   (United States)

^e BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH   (United States)

^f Clinical Development   (United States)

Author keywords

conjugate vaccine; immunogenicity; infants; meningococcal disease; safety

Indexed keywords

BACTERIUM ANTIBODY; MENINGOCOCCUS VACCINE;

ADVERSE OUTCOME; ARTICLE; BACTERICIDAL ACTIVITY; CONTROLLED STUDY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; GEOMETRY; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INFANT; MAJOR CLINICAL STUDY; MALE; MENINGOCOCCOSIS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEIZURE; SEROLOGY; UNSPECIFIED SIDE EFFECT; VACCINATION;

ANTIBODIES, BACTERIAL; FEMALE; HUMANS; IMMUNIZATION SCHEDULE; INFANT; MALE; MENINGOCOCCAL INFECTIONS; MENINGOCOCCAL VACCINES; NEISSERIA MENINGITIDIS; TREATMENT OUTCOME; UNITED STATES; VACCINATION; VACCINES, CONJUGATE;

EID: 84855448055     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0b013e31823dce5c     Document Type: Article

References (19)

1. Girard MP, Preziosi MP, Aguado MT, et al. A review of vaccine research and development: meningococcal disease. Vaccine. 2006;24:4692-4700. (Pubitemid 43776790)
2. Rosenstein NE, Perkins BA, Stephens DS, et al. The changing epidemiology of meningococcal disease in the United States, 1992-1996. J Infect Dis. 1999;180:1894-1901.
3. Thompson MJ, Ninis N, Perera R, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367:397-403. (Pubitemid 43184259)
4. Bilukha OO, Rosenstein N. Prevention and control of meningococcal disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2005;54(RR-7):1-21.
5. Stephens DS, Greenwood B, Brandtzaeg P. Epidemic meningitis, meningococcaemia, and Neisseria meningitidis. Lancet. 2007;369:2196-2210. (Pubitemid 46977462)
6. Rennels M, King J Jr, Ryall R, et al. 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. (Pubitemid 38621482)
7. Harrison LH, Trotter CL, Ramsay ME. Global epidemiology of meningococcal disease. Vaccine. 2009;27(suppl 2):B51-B63.
8. Cooper B, DeTora L, Stoddard J. Menveo: a novel quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135 and Y. Expert Rev Vaccines. 2011;10:21-33.
9. Gasparini R, Conversano M, Bona G, et al. Randomized trial on the safety, tolerability, and immunogenicity of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, administered concomitantly with a combined tetanus, reduced diphtheria, and acellular pertussis vaccine in adolescents and young adults. Clin Vaccine Immunol. 2010;17:537-544.
10. Reisinger KS, Baxter R, Block SL, et al. Quadrivalent meningococcal vaccination of adults: phase III comparison of an investigational conjugate vaccine, MenACWY-CRM, with the licensed vaccine, Menactra. Clin Vaccine Immunol. 2009;16:1810-1815.
11. Stamboulian D, Lopardo G, Lopez P, et al. 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-e875.
12. Arguedas A, Soley C, Loaiza C, 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.
13. 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-e10.
14. Halperin SA, Gupta A, Jeanfreau R, et al. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010; 28:7865-7872.
15. Perrett KP, Snape MD, Ford KJ, et al. Immunogenicity and immune memory of a nonadjuvanted quadrivalent meningococcal glycoconjugate vaccine in infants. Pediatr Infect Dis J. 2009;28:186-193.
16. Snape MD, Perrett KP, Ford KJ, et al. Immunogenicity of a tetravalent meningococcal glycoconjugate vaccine in infants: a randomized controlled trial. JAMA. 2008;299:173-184.
17. Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969;129: 1307-1326.
18. Granoff DM. Relative importance of complement-mediated bactericidal and opsonic activity for protection against meningococcal disease. Vaccine. 2009;27(suppl 2):B117-B125.
19. 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;27:5574-5580.