Two versus three doses of a meningococcal C conjugate vaccine concomitantly administered with a hexavalent DTaP-IPV-HBV/Hib vaccine in healthy infants

Vaccine

Volumn 26, Issue 18, 2008, Pages 2242-2252

  Schmitt, Heinz J ^a   Steul, Katrin Simone ^a   Borkowski, Astrid ^b   Ceddia, Francesca ^c   Ypma, Ellen ^d   Knuf, Markus ^a  

^a JOHANNES GUTENBERG UNIVERSITY   (Germany)

^b Chiron Behring GmbH & Co   (Germany)

^c NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

^d Novartis Vaccines   (Netherlands)

Author keywords

Co administration; Conjugate vaccines; Meningococcal disease

Indexed keywords

BACTERIAL ANTIGEN; BACTERIUM ANTIBODY; DIPHTHERIA PERTUSSIS POLIOMYELITIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B HEPATITIS B VACCINE; IMMUNOGLOBULIN G ANTIBODY; MENINGOCOCCAL SEROGROUP A C POLYSACCHARIDE VACCINE; MENINGOCOCCUS VACCINE; MENINGOKOKKEN IMPFSTOFF A+C; POLYSACCHARIDE VACCINE; UNCLASSIFIED DRUG; VIRUS ANTIGEN;

ACTIVE IMMUNIZATION; ANTIBODY BLOOD LEVEL; ANTIBODY RESPONSE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIPHTHERIA; DOSAGE SCHEDULE COMPARISON; DRUG DOSE REGIMEN; DRUG SAFETY; DRUG TOLERABILITY; EATING HABIT; FEMALE; FEVER; HEPATITIS B; HEPATITIS B VIRUS; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; IMMUNOLOGICAL MEMORY; INFANT; INFLUENZA; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE REACTION; INJECTION SITE SWELLING; INJECTION SITE TENDERNESS; IRRITABILITY; MAJOR CLINICAL STUDY; MALE; MENINGITIS; MENINGOCOCCOSIS; MULTICENTER STUDY; NORMAL HUMAN; PATHOLOGICAL CRYING; PERTUSSIS; POLIOMYELITIS; PRIORITY JOURNAL; PROTEIN DETERMINATION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; SOMNOLENCE; TETANUS; VACCINATION; VOMITING;

ANTIBODIES, BACTERIAL; BACTERIAL CAPSULES; FEMALE; HAEMOPHILUS VACCINES; HEPATITIS B ANTIBODIES; HUMANS; IMMUNIZATION SCHEDULE; IMMUNIZATION, SECONDARY; IMMUNOLOGIC MEMORY; INFANT; MALE; MENINGITIS, MENINGOCOCCAL; MENINGOCOCCAL VACCINES; MICROBIAL VIABILITY; VACCINES, COMBINED; VACCINES, CONJUGATE;

EID: 42449158897     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2008.02.041     Document Type: Article

References (33)

1. DeVoe I.W. The meningococcus and mechanisms of pathogenicity. Microbiol Rev 46 2 (1982) 162-190
2. Goldschneider I., Gotschlich E.C., and Artenstein M.S. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med 129 6 (1969) 1307-1326
3. Rosenstein N.E., Perkins B.A., Stephens D.S., Popovic T., and Hughes J.M. Meningococcal disease. N Engl J Med 344 18 (2001) 1378-1388
4. Connolly M., and Noah N. Is group C meningococcal disease increasing in Europe? A report of surveillance of meningococcal infection in Europe 1993-1996. Epidemiol Infect 122 1 (1999) 41-49
5. Centers for Disease Control and Prevention. Control and prevention of meningococcal disease and control and prevention of serogroup C meningococcal disease: evaluation and management of suspected outbreaks. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR; 1997 46(RR-5):1-21.
6. Girard M.P., Preziosi M.P., Aguado M.T., and Kieny M.P. A review of vaccine research and development: meningococcal disease. Vaccine 24 (2006) 7025-7026
7. Bramley J.C., Hall T., Finn A., Buttery R.B., Elliman D., Lockhart S., et al. Safety and immunogenicity of three lots of meningococcal serogroup C conjugate vaccine administered at 2, 3 and 4 months of age. Vaccine 19 20-22 (2001) 2924-2931
8. Miller E., Salisbury D., and Ramsay M. Planning, registration and implementation of an immunization campaign against meningococcal serogroups C disease in the UK: a success story. Vaccine 20 Suppl. 1 (2001) S58-S67
9. National Advisory Committee on Immunization. Supplementary statement on conjugate meningococcal vaccines. Can Commun Dis Rep;2003 29:10-11.
10. Health Protection Agency. Routine childhood immunisation schedule (Available at: http://www.hpa.org.uk) (Accessed February 2007).
11. Centers for Disease Control and Prevention. Recommended immunization schedule for persons aged 0-6 years; United States 2007 (Available at: http://www.cdc.gov/vaccines/recs/schedules/downloads/child/2007/child-sc hedule-bw-print.pdf) (Accessed February 2008).
12. Kalies H., Grote V., Verstraeten T., Hessel L., Schmitt H.J., and von Kries R. The use of combination vaccines has improved timeliness of vaccination in children. Pediatr Infect Dis J 25 6 (2006) 507-512
13. European Medicines Agency. Press Release. European Medicines Agency recommends suspension of Hexavac; 2005 (Available at http://www.emea.europa.eu/pdfs/human/press/pr/29736905en.pdf) (Accessed February 2008).
14. Granoff D.M., Maslanka S.E., Carlone G.M., Plikaytis B.D., Santos G.G., Mokatrin A., et al. A modified enzyme-linked immunosorbent assay for measurement of antibody responses to meningococcal C polysaccharide that correlate with bactericidal responses. Clin Diagn Lab Immunol 5 4 (1998) 479-485
15. Maslanka S.E., Gheesling L.L., Libutti D.E., Donaldson K.B., Harakeh H.S., Dykes J.K., et al. Standardization and a multilaboratory comparison of Neisseria meningitidis serogroup A and C serum bactericidal assays. The Multilaboratory Study Group. Clin Diag Lab Immunol 4 2 (1997) 156-167
16. Maclennan J.M., Shackley F., Heath P.T., Deeks J.J., Flamank C., Herbert M., et al. Safety, immunogenicity, and induction of immunologic memory by a serogroup C meningococcal conjugate vaccine in infants. JAMA 283 21 (2000) 2795-2801
17. Jilg W., Schmidt M., and Deinhardt F. Immune responses to late booster doses of hepatitis B vaccine. J Med Virol 17 3 (1985) 249-254
18. Poland G.A. Adolescent hepatitis B immunization: making it simpler. Pediatrics 107 4 (2001) 771-772
19. Trotter C.L., Andrews N.J., Kaczmarski E.B., Miller E., and Ramsay M.E. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet 364 9431 (2004) 365-367
20. Borrow R., Goldblatt D., Finn A., Southern J., Ashton L., Andrews N., et al. Immunogenicity of, and immunologic memory to, a reduced primary schedule of meningococcal C-tetanus toxoid conjugate vaccine in infants in the United Kingdom. Infect Immun 71 10 (2003) 5549-5555
21. Snape M.D., Kelly D.F., Green B., Moxon E.R., Borrow R., and Pollard A.J. Lack of bactericidal activity in preschool children two years after a single dose of serogroup C meningococcal polysaccharide-protein conjugate vaccine. Pediatr Infect Dis J 24 2 (2005) 128-131
22. Steinhoff M., and Goldblatt D. Conjugate Hib vaccines. Lancet 361 9355 (2003) 360-361
23. Kelly D., Snape M.D., Clutterbuck E.C., Green S., Snowden C., Diggle L., et al. CRM197-conjugated serogroup C meningococcal capsular polysaccharide, but not the native polysaccharide, induces persistent antigen specific memory B cells. Blood 108 8 (2006) 2642-2647
24. Tejedor J.C., Omenaca F., Garcia-Sicilia J., Verdaguer J., Van Esso D., Esporrin C., et al. Spanish DTaP-HBV-IPV/Hib-076 Study Group. Immunogenicity and reactogenicity of a three-dose primary vaccination course with a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type b vaccine coadministered with a meningococcal C conjugate vaccine. Pediatr Infect Dis J 23 12 (2004) 1109-1115
25. Data on file: Novartis Vaccines study number V14P38E1.
26. Lakshman R., Jones I., Walker D., McMurtrie K., Shaw L., Race G., et al. Safety of a new conjugate meningococcal C vaccine in infants. Arch Dis Child 85 5 (2001) 391-397
27. Halperin S.A., McDonald J., Samson L., Danzig L., Santos G., Izu A., et al. Simultaneous administration of meningococcal C conjugate vaccine and diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine in children: a randomized double-blind study. Clin Invest Med 25 6 (2002) 243-251
28. MacDonald N.E., Halperin S.A., Law B.J., Forrest B., Danzig L.E., and Granoff D.M. Induction of immunologic memory by conjugated vs plain meningococcal C polysaccharide vaccine in toddlers: a randomized controlled trial. JAMA 280 19 (1998) 1685-1689
29. MacDonald N.E., Halperin S.A., Law B.J., Danzig L.E., and Granoff D.M. Can meningococcal C conjugate vaccine overcome immune hyporesponsiveness induced by previous administration of plain polysaccharide vaccine?. JAMA 283 14 (2000) 1826-1827
30. Richmond P., Borrow R., Goldblatt D., Findlow J., Martin S., Morris R., et al. Ability of three different meningococcal C conjugate vaccines to induce immunological memory after a single dose in UK toddlers. J Infect Dis 183 1 (2001) 160-163
31. Choo S., Zuckerman J., Goilav C., Hatzmann E., Everard J., and Finn A. Immunogenicity and reactogenicity of a group C meningococcal conjugate vaccine compared with a group A + C meningococcal polysaccharide vaccine in adolescents in a randomised observer-blind controlled trial. Vaccine 18 24 (2000) 2686-2692
32. De Wals P., Deceuninck G., Boulianne N., and De Serres G. Effectiveness of a mass immunization campaign using serogroup C meningococcal vaccine. JAMA 292 20 (2004) 2491-2494
33. Data on file: Novartis Vaccines study number V14P17.