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

Clinical and Vaccine Immunology

Volumn 17, Issue 4, 2010, Pages 537-544

  Gasparini, Roberto ^a   Conversano, Michele ^b   Bona, Gianni ^c   Gabutti, Giovanni ^d   Anemona, Alessandra ^e   Dull, Peter M ^f   Ceddia, Francesca ^e  

^a UNIVERSITY OF GENOA   (Italy)

^b Taranto Local Health Agency   (Canada)

^c UNIVERSITY OF EASTERN PIEDMONT   (Italy)

^d UNIVERSITY OF FERRARA   (Italy)

^e NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

^f Novartis Vaccines and Diagnostics Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIAL ANTIGEN; BACTERIUM ANTIBODY; DIPHTHERIA ANTIBODY; DIPHTHERIA PERTUSSIS TETANUS VACCINE; GLYCOCONJUGATE; HEMAGGLUTININ; MENACWY CRM; MENINGOCOCCAL SEROGROUP A; MENINGOCOCCAL SEROGROUP C; MENINGOCOCCAL SEROGROUP W 135; MENINGOCOCCAL SEROGROUP Y; MENINGOCOCCUS VACCINE; PERTACTIN; PERTUSSIS ANTIBODY; PERTUSSIS TOXIN; PLACEBO; TETANUS ANTIBODY; UNCLASSIFIED DRUG;

ADOLESCENT; ADULT; ANTIBODY RESPONSE; ARTHRALGIA; ARTICLE; BACTERIAL IMMUNITY; CHILD; CHILL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIPHTHERIA; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FEVER; HEADACHE; HUMAN; IMMUNIZATION; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; MAJOR CLINICAL STUDY; MALAISE; MALE; MENINGOCOCCOSIS; MONOTHERAPY; MULTICENTER STUDY; MYALGIA; NAUSEA; PERTUSSIS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SINGLE BLIND PROCEDURE; SINGLE DRUG DOSE; TETANUS;

ADOLESCENT; ADULT; ANTIBODIES, BACTERIAL; CHILD; DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS VACCINES; FEMALE; HUMANS; MALE; MENINGOCOCCAL VACCINES; PLACEBOS; VACCINES, CONJUGATE; YOUNG ADULT;

EID: 77950658432     PISSN: 15566811     EISSN: 1556679X     Source Type: Journal    
DOI: 10.1128/CVI.00436-09     Document Type: Article

References (23)

1. American Academy of Pediatrics Committee on Infectious Diseases. 2005. Prevention and control of meningococcal disease: recommendations for use of meningococcal vaccines in pediatric patients. Pediatrics 116:496-505.
2. Bilukha, O. O., N. Rosenstein, et al. 2005. Prevention and control of meningococcal disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recommend. Rep. 54(RR-7):1-21.
3. Broder, K. R., M. M. Cortese, J. K. Iskander, K. Kretsinger, B. A. Slade, K. H. Brown, C. M. Mijalski, T. Tiwari, E. J. Weston, A. C. Chon, P. U. Srivastava, J. S. Moran, B. Schwartz, and T. V. Murphy. 2006. Preventing tetanus, diphtheria, and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recommend. Rep. 55(RR-3):1-34.
4. Burrage, M., A. Robinson, R. Borrow, N. Andrews, J. Southern, J. Findlow, S. Martin, C. Thorton, D. Goldblatt, M. Corbel, D. Sesardic, K. Cartwight, P. Richmond, and E. Miller. 2002. Effect of vaccination with carrier protein on response to meningococcal C conjugate vaccines and value of different immunoassays as predictors of protection. Infect. Immun. 70:4946-4954.
5. Cherry, J. D., J. Gornbein, U. Heininger, and K. Stehr. 1998. A search for serologic correlates of immunity to Bordetella pertussis cough illnesses. Vaccine 16:1901-1906.
6. Edwards, K. M., and M. D. Decker. 2008. Pertussis vaccines, p. 467-517. In S. Plotkin, W. Orenstein, and P. Offit (ed.), Vaccines, 5th ed. Saunders/Elsevier, Philadelphia, PA
7. European Union Invasive Bacterial Infections Surveillance Network (EU-IBIS). 2006. Invasive Neisseria meningitidis in Europe 2006. Health Protection Agency, London, United Kingdom. http://www.euibis.org/documents/2006- meningo.pdf
8. European Union Invasive Bacterial Infections Surveillance Network (EU-IBIS). 9 January 2009, accession date. Age distribution of culture-confirmed Neisseria meningitidis cases in all reporting countries, by year, 1999-2006. http://www.euibis.org/php/meningo-age-chart.php?item=culture&country =All+countries.
9. EUVAC.NET. 9 January 2009, accession date. National childhood vaccination schedules. http://www.euvac.net/graphics/euvac/vaccination/vaccination.html.
10. Friedland, L., W. Weston, and B. Howe. 2007. Immunogenicity of coadministered Tdap and MCV4 vaccines compared to separately administered vaccines, poster G-1699, p. 282. 47th Annu. Intersci. Conf. Antimicrob. Agents Chemother., Chicago, IL, 17 to 20 September 2007.
11. Goldschneider, I., E. C. Gotschlich, and M. S. Artenstein. 1969. Human immunity to the meningococcus. I. The role of humoral antibodies. J. Exp. Med. 129:1307-1326.
12. Granoff, D. M., L. H. Harrison, and R. Borrow. 2008. Meningococcal vaccines, p. 399-434. In S. Plotkin, W. Orenstein, and P. Offit (ed)., Vaccines, 5th ed. Saunders/Elsevier, Philadelphia, PA.
13. Jackson, L. A., R. M. Jacobson, K. S. Reisinger, A. Anemona, L. E. Danzig, and P. M. Dull. 2009. A randomized trial to determine the tolerability and immunogenicity of a quadrivalent meningococcal glycoconjugate vaccine in healthy adolescents. Pediatr. Infect. Dis. J. 28:86-91.
14. Mayer, L. W., M. W. Reeves, N. Al-Hamdan, C. T. Sacchi, M. K. Taha, G. W. Ajello, S. E. Schmink, C. A. Noble, M. L. Tondella, A. M. Whitney, Y. Al-Mazrou, M. Al-Jefri, A. Mishkhis, S. Sabban, D. A. Caugant, J. Lingappa, N. E. Rosenstein, and T. Popovic. 2002. Outbreak of W135 meningococcal disease in 2000: not emergence of a new W135 strain but clonal expansion within the electrophoretic type-37 complex. J. Infect. Dis. 185:1596-1605.
15. Middleman, A. B. 2007. New adolescent vaccination recommendations and how to make them "stick." Curr. Opin. Pediatr. 19:411-416.
16. Rosenstein, N. E., B. A. Perkins, D. S. Stephens, L. Lefkowitz, M. L. Cartter, R Danila, P. Cieslak, K. A. Shutt, T. Popovic, A. Schuchat, L. H. Harrison, and A. L. Reingold. 1999. The changing epidemiology of meningococcal disease in the United States, 1992-1996. J. Infect. Dis. 180:1894-1901.
17. Schmitt, H. J., A. Schuind, M. Knuf, K. Beutel, H. Schulte-Wissermann, M. Gahr, R. Schult, J. Folkens, W. Rauh, H. Bogaerts, H. L. Bork, and R. Clemens. 1996. Clinical experience of a tricomponent acellular pertussis vaccine combined with diphtheria and tetanus toxoids for primary vaccination in 22,505 infants. J. Pediatr. 129:695-701.
18. Schmitt, H. J., C. H. von Konig, A. Neiss, H. Bogaerts, H. L. Bock, H. Schulte-Wissermann, M. Gahr, R. Schult, J. U. Folkens, W. Rauh, and R. Clemens. 1996. Efficacy of acellular pertussis vaccine in early childhood after household exposure. JAMA 275:37-41.
19. Shepard, C. W., I. R. Ortega-Sanchez, R. D. Scott II, N. E. Rosenstein, and the ABCs Team. 2005. Cost-effectiveness of conjugate meningococcal vaccination strategies in the United States. Pediatrics 115:1220-1232.
20. Snape, M. D., K. P. Perrett, K. J. Ford, T. M. John, D. Pace, L. M. Yu, J. M. Langley, S. McNeil, P. M. Dull, F. Ceddia, A. Anemona, S. A. Halperin, S. Dobson, and A. J. Pollard. 2008. Immunogenicity of a tetravalent meningococcal glycoconjugate vaccine in infants. JAMA 299:173-184.
21. Southern, J., D. Gelb, N. Andrews, P. A. Waight, R. Morris, K. Cartwright, and E. Miller. 2006. Reactogenicity of meningococcal C conjugate vaccines when administered at the same time as, or a month prior to or after, tetanus and diphtheria booster vaccinations. Hum. Vaccin. 2:237-242.
22. Stehr, K., J. D. Cherry, U. Heininger, S. Schmitt-Groh́e, M. Uberall, S. Laussucq, T. Eckhardt, M. Meyer, R. Engelhardt, and P. Christenson. 1998. A comparative efficacy trial in Germany in infants who received either the Lederle/Takeda acellular pertussis component DTP (DTaP) vaccine, the Lederle whole-cell component DTP vaccine, or DT vaccine. Pediatrics 101(1 Pt 1):1-11.
23. Storsaeter, J., H. O. Hallander, L. Gustafsson, and P. Olin. 1998. Levels of anti-pertussis antibodies related to protection after household exposure to Bordetella pertussis. Vaccine 16:1907-1916.