Combined DTP-HBV-HIB vaccine versus separately administered DTP-HBV and HIB vaccines for primary prevention of diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae B (HIB)

Cochrane Database of Systematic Reviews

Volumn , Issue 3, 2009, Pages

  Bar On, Edna S ^a   Goldberg, Elad ^a   Fraser, Abigail ^b   Vidal, Liat ^a   Hellmann, Sarah ^a   Leibovici, Leonard ^a  

^a RABIN MEDICAL CENTER   (Israel)

^b UNIVERSITY OF BRISTOL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS HAEMOPHILUS ILUENZAE TYPE B HEPATITIS B VACCINE; UNCLASSIFIED DRUG;

DIPHTHERIA; DRUG EFFICACY; HAEMOPHILUS INFECTION; HEPATITIS B; HUMAN; IMMUNOGENICITY; PERTUSSIS; PRIMARY PREVENTION; REVIEW; TETANUS;

EID: 70149083221     PISSN: 1469493X     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD005530.pub2     Document Type: Review

References (59)

1. Aristegui J, Dal-Re R, Diez-Delgado J, Mares J, Casanovas JM, Garcia-Corbeira P, et al.Comparison of the reactogenicity and immunogenicity of a combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio (DTPa-HBV-IPV) vaccine,mixed with the Haemophilus influenzae type b (Hib) conjugate vaccine and administered as a single injection, with the DTPa-IPV/Hib and hepatitis B vaccines administered in two simultaneous injections to infants at 2, 4 and 6 months of age. Vaccine 2003;21(25-6):3593-3600
2. Avdicova M, Prikazsky V, Hudeckova H, Schuerman L, Willems P. Immunogenicity and reactogenicity of a novel hexavalent DTPa-HBV-IPV/Hib vaccine compared to separate concomitant injections of DTPa-IPV/Hib and HBV vaccines, when administered according to a 3, 5 and 11 month vaccination schedule. European Journal of Pediatrics 2002;161(11):581-587 (Pubitemid 35471811)
3. Bravo L, Carlos J, Gatchalian S, Borja-Tabora C, Bibera G, Willems P, et al.The new DTPw-HBV-Hib combination vaccine can be used at the who schedule with a monovalent dose of hepatitis B vaccine at birth. Southeast Asian Journal of Tropical Medicine and Public Health 1998;29(4):772-778 (Pubitemid 128709190)
4. Faingezicht I, Avila-Aguerro ML,Cervantes Y, Fourneau M, Clemens SA. Primary and booster vaccination with DTPw-HB/Hib pentavalent vaccine in Costa Rican children who had received a birth dose of hepatitis b vaccine. Pan American Journal of Public Health 2002; 12(4):247-257 (Pubitemid 35283053)
5. Gabutti G, Zepp F, Schuerman L, Dentico P, Bamfi F, Soncini R, et al.Evaluation of the immunogenicity and reactogenicity of a DTPa-HBV-IPV. Combination vaccine co-administered with a Hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age. Scandinavian Journal of Infectious Diseases 2004;36(8):585-592 (Pubitemid 39255358)
6. Gabutti G, Bona G, Dentico P, Bamfi F, Hardt K, Majori S, et al.Immunogenicity and reactogenicity following primary immunisation with a combined DTaP-HBV vaccine and a Haemophilus influenzae type B vaccine administered by separate or mixed injection. Clinical Drug Investigation 2005;25(5):315-323 (Pubitemid 40806945)
7. Greenberg DP, Wong VK, Partridge S, Chang SJ, Jing J, Howe BJ, et al.Immunogenicity of a Haemophilus influenzae type b-tetanus toxoid conjugate vaccine whenmixed with a diphtheria-tetanus-acellular pertussis-hepatitis B combination vaccine. Pediatric Infectious Disease Journal 2000;19(12):1135-1140 (Pubitemid 32003355)
8. Mallet E, Fabre P, Pines E, Salomon H, Staub T, Schodel F, et al.Immunogenicity and safety of a new liquid hexavalent combined vaccine compared with separate administration of reference licensed vaccines in infants. Pediatric Infectious Disease Journal 2000;19(12): 1119-1127 (Pubitemid 32003353)
9. Nolan T, Hogg G, Darcy MA, Skeljo M, Carlin J, Boslego J. A combined liquid Hib (PRP-OMPC), hepatitis B, diphtheria, tetanus and whole-cell pertussis vaccine: controlled studies of immunogenicity and reactogenicity. Vaccine 2001;19(15-16):2127-2137 (Pubitemid 32178363)
10. Omenaca F, Dal-Re R, D'Apuzzo V, Kattamis C, Gnehm HP, Garcia-Sicilia J, et al.Reactogenicity of DTPa-HBV/Hib vaccine administered as a single injection vs DTPa-HBV and Hib vaccines administered simultaneously at separate sites, to infants at 2, 4 and 6 months of age. Vaccine 2001;19(30):4260-4266 (Pubitemid 32703648)
11. Ortega-Barria E, Kanra G, Leroux G, Bravo L, Safary A, Levlevre I. The immunogenicity and reactogenicity of DTPw-HBV/Hib 2.5 combination vaccine: Results from four phase III multicenter trials across three continents. Vaccine 2007;25(50):8432-8440 (Pubitemid 350137598)
12. Pichichero ME, Passador S. Administration of combined diphtheria and tetanus toxoids and pertussis vaccine, hepatitis B vaccine, and Haemophilus influenzae type b (Hib) vaccine to infants and response to a booster dose of Hib conjugate vaccine. Clinical Infectious Diseases 1997;25(6):1378-1384 (Pubitemid 28022675)
13. Ramkissoon A, Coovadia HM, Jugnundan P, Willems P, Clemens BR. A new combined DTP-HBV-Hib vaccine - strategy for incorporation of Hib vaccination into childhood immunisation programmes. South African Medical Journal 2001;91(10):864-869 (Pubitemid 33062318)
14. Riedemann S, Reinhardt G, Jara J, Rios R, Wenzel MS, Willems P, et al.Immunogenicity and reactogenicity of combined versus separately administered DTPw-HBV and Hib vaccines given to healthy infants at 2, 4, and 6 months of age, with a booster at 18 months. International Journal of Infectious Diseases 2002;6(3):215-222
15. Santos JI, Martin A, De Leon T, Rivera L, Gaitan ME, Del Rio C, et al.DTPw-HB and Hib primary and booster vaccination: combined versus separate administration to Latin American children. Vaccine 2002;20(13-4):1887-1893 (Pubitemid 34242847)
16. Schmitt HJ, Knuf M, Ortiz E, Sanger R, Uwamwezi MC, Kaufhold A. Primary vaccination of infants with diphtheria-tetanus-acellular pertussis-hepatitis B virus- inactivated polio virus and Haemophilus influenzae type b vaccines given as either separate ormixed injections. Journal of Pediatrics 2000;137(3):304-312 (Pubitemid 30701711)
17. Tregnaghi M, Lopez P, Rocha C, Rivera L, David M, Ruttimann R. A new DTPw-HB/Hib combination vaccine for primary and booster vaccination of infants in Latin America. Pan American Journal of Public Health 2006;19(3):179-188 (Pubitemid 44147374)
18. Win KM, Aye M, Htay-Htay H, Safary A, et al.Comparison of separate and mixed administration of DTPw-HBV and Hib vaccines: Immunogenicity and reactogenicity profiles. International Journal of Infectious Diseases 1997;2(2):79-84. (Pubitemid 28117646)
19. * Aristegui J, Dal-Re R, Garrote E, Gonzalez A, Arrate JP, Perez A. Assessment of the immunogenicity and reactogenicity of a quadrivalent diphtheria, tetanus, acellular pertussis and hepatitis B (DTPa-HBV) vaccine administered in a single injection with Haemophilus influenzae type b conjugate vaccine, to infants at 2, 4 and 6 months of age. Vaccine 1998;16(20):1976-1981
20. * Aristegui J, Garcia-Corbeira P, De-la-Flor J, Dal-Re R, Mares J, Moraga F, et al.Reactogenicity and safety of DTPa vaccine and Haemophilus influenzae type b conjugate vaccine (Hib) in a single injection vs DTPw and Hib as separate injections as a booster vaccination in 18-month-old children. Clinical Drug Investigation 2001; 21(1):9-16.
21. Bavdekar SB, Maiya PP, Subba Rao SD, Bock HL. Immunogenicity and safety of combined diphtheria tetanus whole cell pertussis hepatitis B/ Haemophilus influenzae type b vaccine in Indian infants. Indian Pediatr. 2007;Jul;44(7):505-510
22. * Botet-Asensi FI, Veronese A, Del Carmen Otero M, Desamparados Tamarit Perez M, Hontangas Lopez JL, Viviani S. Immunogenicity and safety in infants of a DTwPHib full liquid vaccine. Acta Pediatrica 2003;92(5):541-545
23. * Calbo F, Dal Re R, Diez Delgado J, Ona S, Sanchez Prados F, Garcia Corbeira P, et al.Comparative trial to assess the reactogenicity of the diphtheria-tetanusacellular pertussis (DTPa) vaccine plus Haemophilus influenza type b (Hib) conjugate vaccine and that of the diphtheria-tetanus-whole cell pertussis (DTPw) vaccine plus Hib conjugate vaccine, administered in single injection as a booster dose to 14-20 months-old children. Medicina Clinica 2002;118(1):1-4.
24. * Clemens SC, Azevedo T, Homma A. Feasibility study of the immunogenicity and safety of a novel DTPw/Hib (PRP-T) Brazilian combination compared to a licensed vaccine in healthy children at 2, 4, and 6 months of age. Revista da Sociedade Brasileira de Medicina Tropical 2003;36(3):321-330
25. Denoel PA, Goldblatt D, de Vleeschauwer I, Jacquet JM, Pichichero ME, Poolman JT. Quality of the Haemophilus influenzae type b (Hib) antibody response induced by diphtheria-tetanus-acellular pertussis/ Hib combination vaccines. Clinical and Vaccine Immunology 2007;October 14(10):1362-1369 (Pubitemid 350012980)
26. Gatchalian S, Reyes M, Bernal N, Lefevre I, David MP, Han HH, et al.A new DTPw-HBV/Hib vaccine is immunogenic and safe when administered according to the EPI (Expabded Programme for Immunization) schedule and following hepatitis B vaccination at birth. Human Vaccines 2005;1(5):198-203.
27. * Gylca R, Gylca V, Benes O, Melnic A, Chicu V, Weisbecker C, et al.A new DTPa-HBV-IPV vaccine co-administered with Hib, compared to a commercially available DTPw-IPV/Hib vaccine co-administered with HBV, given at 6, 10 and 14 weeks following HBV at birth. Vaccine 2001;19(7-8):825-833
28. Hla KH, Thein SA, Aye A, Han HH, Bock HL, David MP, et al.Reactogenicity and immunogenicity profiles of a novel pentavalent diphtheria-tetanus-whole cell pertussis-hepatitis B and Haemophilus influenzae type B vaccine: a randomized dose-ranging trial of the Hib tetanus-conjugate content. Pediatric Infectious Disease Journal 2006;25(8):706-712 (Pubitemid 44162128)
29. * Hogg K, Hogg G. The immunogenicity of oral poliomyelitis vaccine in a primary vaccination series at 2, 4 and 6 months given concurrently with Hib, hepatitis B and diphtheria, tetanus and wholecell pertussis vaccines administered as three separate injections or as a combination pentavalent vaccine. Vaccine 2003;21(21-2):2906-2910
30. * Huang LM, Chang PF, Lee PI, Chiu HH, Tsai SY, Lee CY. Immunogenicity and safety of Haemophilus influenzae type b conjugate vaccine (HibTITER) and a combination vaccine of diphtheria, tetanus, pertussis and HibTITER (TETRAMUNE) in two-monthold infants. Journal of Microbiology, Immunology, and Infection 1998; 31(3):180-186
31. *Kalies H, Verstraeten T, Grote V, Meyer N, Siedler A, Schmitt HJ, et al.Four and one-half-year follow-up of the effectiveness of diphtheria-tetanus toxoids-acellular pertussis/Haemophilus influenzae type b and diphtheria-tetanus toxoids-acellular pertussis-inactivated poliovirus/ H. influenzae type b combination vaccines in Germany. Pediatric Infectious Disease Journal 2004;23(10):944-950
32. Kanra G, Kara A, Demiralp O, Contorni M, Hilbert AK, Spyr C, et al.Safety and immunogenicity of a new fully liquid DTPw-HepB-Hib combination vaccine in infants. Human Vaccines 2006;2(4): 155-160 (Pubitemid 44422481)
33. Knuf M, Habermehl P, Cimino C, Petersen G, Schmitt HJ, Habermehl P. Immunogenicity, reactogenicity and safety of a 7-valent pneumococcal conjugate vaccine (PCV7) concurrently administered with a DTPa-HBV-IPV/Hib combination vaccine in healthy infants. Vaccine 2006;24(22):4727-4736 (Pubitemid 43776787)
34. Lagos R, Hoffenbach A, Scemama M, Dupuy M, Schodel F, Hessel L, et al.Lot-to-lot consistency of a combined hexavalent diptheria- tetanus-acellular-pertussis, hepatitis B, Inactivated polio and haemophilus B conjugate vaccine, administered to healthy Chilean infants at two, four and six months of age. Human Vaccines 2005;1 (3):112-117
35. Lim FS, Han HH, Jacquet JM, Bock HL. Primary vaccination of infants against hepatitis B can be completed using a combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis-Haemophilus influenzae type B vaccine. Annals of the Academy of Medicine, Singapore 2007;Oct 36(10):801-806
36. Lopez P, Rubiano L, del Pilar Rubio M, David MP, Safary A. Immunogenicity and reactogenicity of DTPw-HB/Hib vaccine administered to Colombian infants after a birth dose of hepatitis B vaccine. Expert Review of Vaccines 2002;1(3):277-283 (Pubitemid 36559864)
37. Meriste S, Lutsar I, Tamm E, Willems P. Safety and immunogenicity of a primary course and booster dose of a combined diphtheria, tetanus, acellular pertussis, hepatitis B and inactivated poliovirus vaccine. Scandinavian Journal of Infectious Diseases May;38(5):350-356
38. * Mills E, Gold R, Thipphawong J, Barreto L, Guasparini R, Meekison W, et al.Safety and immunogenicity of a combined five-component pertussis-diphtheria-tetanus-inactivated poliomyelitis-Haemophilus B conjugate vaccine administered to infants at two, four and six months of age. Vaccine 1998;16(6):576-585
39. Nolan T, Altmann A, Skeljo M, Streeton C, Schuerman L. Antibody persistence, PRP-specific immune memory, and booster responses in infants immunised with a combination DTPa-HBV-IPV/Hib vaccine. Vaccine 2004;23(1):14-20. (Pubitemid 39451795)
40. * Pichichero ME, Voloshen T, Zajac D, Passador S. Avidity maturation of antibody to Haemophilus influenzae type b (Hib) after immunization with diphtheria-tetanus-acellular pertussis-hib-hepatitis B combined vaccine in infants. Journal of Infectious Diseases 1999; 180(4):1390-1393
41. Pichichero ME, Bernstein H, Blatter MM, Schuerman L, Cheuvart B, Holmes SJ. Immunogenicity and safety of a combination diphtheria, tetanus toxoid, acellular pertussis, hepatitis B, and inactivated poliovirus vaccine co administered with a 7-valent pneumococcal conjugate vaccine and a Haemophilus influenzae type b conjugate vaccine. Journal of Pediatrics 2007;151(1):43-9;e1- 2. (Pubitemid 46950890)
42. * Poolman J, Kaufhold A, De Grave D, Goldblatt D. Clinical Relevance of Lower Hib Response in DTPa-based Combination Vaccines. Vaccine 2001;19(17-9):2280-2285
43. Saenger R, Maechler G, Potreck M, Zepp F, Knuf M, Habermehl P, et al.Booster vaccination with hexavalent DTPa-HBV-IPV/Hib vaccine in the second year of life is as safe as concomitant DTPa-IPV/Hib +HBV-administered separately. Vaccine 2005;23(9):1135-1143 (Pubitemid 40063547)
44. Scheifele DW, Halperin SA, Rubin E, Tapiero B, Guasparini R, Meekison W, et al.Safety and immunogenicity of a pentavalent combination vaccine (diphtheria, tetanus, accellular pertussis, polio and haemophilus influenzae type B conjugate) when administered as a fourth dose at 15 to 18 months of age. Human Vaccines 2005;1(5): 180-186
45. Scheifele DW, Halperin SA, Smith B, Ochnio J, Meloff K, Duarte-Monteiro D. Assessment of the compatibility of co-administered 7-valent pneumococcal conjugate, DTaP. IPV/PRP-THib and hepatitis B vaccines in infants 2-7 months of age. Vaccine 2006;24(12):2057-2064 (Pubitemid 43255147)
46. Tichmann I, Preidel H, Grunert D, Habash S, Schult R, Maier R, et al.Comparison of the immunogenicity and reactogenicity of two commercially available hexavalent vaccines administered as a primary vaccination course at 2, 4 and 6 months of age. Vaccine 2005;23 (25):3272-3279 (Pubitemid 40523120)
47. Tichmann-Schumann I, Soemantri P, Behre U, Disselhoff J, Mahler H, Maechler G, et al.Immunogenicity and reactogenicity of four doses of diphtheria-tetanus-three-component acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b vaccine coadministered with 7-valent pneumococcal conjugate vaccine. Pediatric Infectious Disease Journal 2005;24(1):70-77 (Pubitemid 40353319)
48. * Trollfors B, Taranger J, Lagergard T, Sundh V. Reduced immunogenicity of diphtheria and tetanus toxoids when combined with pertussis toxoid. Pediatric Infectious Disease Journal 2005;24(1):85-86
49. Usonis V, Bakasenas V. Does concomitant injection of a combined diphtheria-tetanus-acellular pertussis -Hepatitis B virus - Inactivated polio virus vaccine influence the reactogenicity and immunogenicity of commercial Haemophilus influenzae type b conjugate vaccines?. European Journal of Pediatrics 1999;158(5):398-402. (Pubitemid 29198196)
50. * Usonis V, Bakasenas V. Evaluation of the immunogenicity and reactogenicity of a new combined diphtheria, tetanus, whole-cell Bordetella pertussis and Hepatitis B vaccine and Haemophilus influenzae type b vaccine in children at 3, 4.5 and 6 months of age. Acta Medica Lituanica 1999;T6:Nr 3.
51. * Zepp F, Schmitt HJ, Kaufhold A, Schuind A, Knuf M, Habermehl P, et al.Evidence for induction of polysaccharide specific B-cell-memory in the 1st year of life: plain Haemophilus influenzae type b-PRP (Hib) boosters children primed with a tetanus-conjugate Hib-DTPa-HBV combined vaccine. European Journal of Pediatrics 1997;156 (1):18-24.
52. Zepp F, Knuf M, Heininger U, Jahn K, Collard A, Habermehl P, et al.Safety, reactogenicity and immunogenicity of a combined hexavalent tetanus, diphtheria, acellular pertussis, hepatitis B, inactivated poliovirus vaccine and Haemophilus influenzae type b conjugate vaccine, for primary immunization of infants. Vaccine 2004;22(17-8): 2226-2233 (Pubitemid 38626062)
53. Ball LK, Falk LA, Horne D, Finn TM. Evaluating the immune response to combination vaccines. Clinical Infectious Diseases 2001;33 (Suppl 4):299-305.
54. Chalmers I, Adams M, Dickersin K, Hetherington J, Tarnow-Mordi W, Meinert C, et al.A cohort study of summary reports of controlled trials. JAMA 1990;263(10):1401-1405 (Pubitemid 20069948)
55. Egger M, Davey Smith G, Schneider M, Minder C. Bias in metaanalysis detected by a simple, graphical test. BMJ 1997;315(7109): 629-634 (Pubitemid 27387172)
56. Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JPT, Green S editor(s). Cochrane Handbook for Systematic Reviews of Interventions. Wiley, 2008.
57. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. The Journal of the American Medical Association 1955;273(5):408-412
58. World Health Organization. Global Programme for Vaccines and Immunization: The WHO position paper on Haemophilus influenza type b conjugate vaccines. Weekly Epidemiological Record 1998;73(10):64-71.
59. Wong SS, Wilczynski NL, Haynes RB. Developing optimal search strategies for detecting clinically sound treatment studies in EMBASE. Journal of the Medical Library Association 2006;94:41-47.