The immunogenicity and reactogenicity of DTPw-HBV/Hib 2.5 combination vaccine: Results from four phase III multicenter trials across three continents

Vaccine

Volumn 25, Issue 50, 2007, Pages 8432-8440

  Ortega Barrìa, Eduardo ^a,b   Kanra, Güler ^c   Leroux, Geert ^d   Bravo, Lulu ^e   Safary, Assad ^a   Lefevre, Inge ^a  

^a GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^b Instituto Commemorativo Gorgas   (Panama)

^c HACETTEPE UNIVERSITY   (Turkey)

^d GHENT UNIVERSITY HOSPITAL   (Belgium)

^e PHILIPPINE GENERAL HOSPITAL   (Philippines)

Author keywords

Combination; DTPw HBV Hib; Review; Vaccination

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS VACCINE; DIPHTHERIA PERTUSSIS TETANUS VACCINE PLUS HAEMOPHILUS INFLUENZAE TYPE B HEPATITIS B VACCINE; HAEMOPHILUS INFLUENZAE TYPE B VACCINE; RECOMBINANT HEPATITIS B VACCINE; UNCLASSIFIED DRUG; VACCINE;

ANOREXIA; ARTICLE; BACTERIAL INFECTION; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVULSION; DIPHTHERIA; DOUBLE BLIND PROCEDURE; DROWSINESS; DRUG CONJUGATION; DRUG SAFETY; ERYTHEMA; FEMALE; FEVER; HEPATITIS B; HUMAN; HYPOTONIC HYPORESPONSIVE EPISODE; IMMUNOGENICITY; INFANT; INJECTION PAIN; IRRITABILITY; MAJOR CLINICAL STUDY; MALE; MENINGOENCEPHALITIS; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROLOGY; SIDE EFFECT; SWELLING; UNSPECIFIED SIDE EFFECT; VIRUS INFECTION;

ANTIBODIES, BACTERIAL; DIPHTHERIA-TETANUS-PERTUSSIS VACCINE; DOUBLE-BLIND METHOD; FEMALE; HAEMOPHILUS VACCINES; HEPATITIS B ANTIBODIES; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VACCINES; HUMANS; IMMUNIZATION SCHEDULE; INFANT; MALE; POLYSACCHARIDES; TREATMENT OUTCOME; VACCINATION; VACCINES, COMBINED; VACCINES, CONJUGATE;

EID: 36248954515     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2007.09.045     Document Type: Article

References (32)

1. World Health Organisation (WHO). Fact Sheets. Hepatitis B. Fact Sheet No. 204. Revised October 2000.
2. Yeoh E.K. Hepatitis B virus infection in children. Vaccine 8 (1990) S29-S30
3. Kane M.A. Status of hepatitis B immunization programmes in 1998. Vaccine 16 Suppl. (1998) S104-S108
4. Peltola H. Worldwide Haemophilus influenzae type b disease at the beginning of the 21st century: global analysis of the disease burden 25 years after the use of the polysaccharide vaccine and a decade after the advent of conjugates. Clin Microbiol Rev 13 (2000) 302-317
5. World Health Organization (WHO). Hepatitis B vaccines. WER 79 (2004) 253-264
6. Bijlmer H.A. Epidemiology of Haemophilus influenzae invasive disease in developing countries and intervention strategies. In: Ellis R.W., and Granoff D.M. (Eds). Development and uses of Haemophilus influenzae b conjugate vaccines (1994), Marcel Dekker, New York 247-264
7. Mulholland K., and Adegbola R. The Gambian Haemophilus influenzae type b vaccine trial: what does it tell us about the burden of Haemophilus influenzae type b disease?. Pediatr Infect Dis J 17 (1998) S123-S125
8. Levine O., Lagos R., Muñoz A., Villaroel J., Alvarez A.M., Abrego P., et al. Defining the burden of pneumonia in children preventable by vaccination against Haemophilus influenzae type b. Pediatr Infect Dis J 18 (1999) 1060-1064
9. World Health Organization (WHO). The children's vaccine initiative and the global programme for vaccines and immunization: recommendations from the special advisory group of experts. Part 1. WER 71 (1996) 261-266
10. World Health Organisation (WHO). Global Programme for Vaccines and Immunization (GPV): The WHO Position Paper on Haemophilus influenzae type b conjugate vaccines. WER 73 (1998) 64-68
11. Meyerhoff A.S., and Jacobs R.J. Do too many shots lead to missed vaccination opportunities? Does it matter?. Prev Med 41 2 (2005) 540-544
12. André F.E. Development and clinical application of new polyvalent combined paediatric vaccines. Vaccine 17 (1999) 1620-1627
13. 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
14. Poovorawan Y., Theamboonlers A., Sanpavat S., et al. The immunogenicity and reactogenicity of combined tetravalent diphtheria, tetanus, pertussis and hepatitis B vaccine in infants. Viral Hep Liver Dis (1994) 526-529
15. Usonis V., Bakasenas V., Taylor D., and Vandepapeliére P. Immunogenicity and reactogenicity of a combined DTPw-hepatitis B vaccine in Lithuanian infants. Eur J Pediatr 155 (1996) 189-193
16. Aristegui J., Garrote E., González A., Arrate J.P., Perez A., and Vandepapeliere P. Immune response to a combined hepatitis B, diphtheria, tetanus and whole-cell pertussis vaccine administered to infants at 2, 4 and 6 months of age. Vaccine 15 (1997) 7-9
17. Diez-Delgado J., Dal-Ré R., Llorente M., González A., and López J. Hepatitis B component does not interfere with the immune response to diphtheria, tetanus and whole-cell Bordetella pertussis components of a quadrivalent (DTPw-HB) vaccine: a controlled trial in healthy infants. Vaccine 15 (1997) 1418-1422
18. Win K.M., Aye M., Htay-Htay H., Safary A., and Bock H. Comparison of separate and mixed administration of DTPw-HBV and Hib vaccines: immunogenicity and reactogenicity profiles. Int J Infect Dis 2 (1997) 79-84
19. 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 J Trop Med Public Health 29 (1998) 772-778
20. Fernández J., Balter S., Feris J., Gomez E., Garib Z., Castellanos P.L., et al. Randomized trial of the immunogencity of fractional dose regimens of PRP-T Haemophilus influenzae type B conjugate vaccine. Am J Trop Med Hyg 62 4 (2000) 485-490
21. Romero-Steiner S., Fernandez J., Biltoft C., Wohl M.E., Sanchez J., Feris J., et al. Functional antibody activity elicited by fractional doses of Haemophilus influenzae type b conjugate vaccine (polyribosylribitol phosphate-tetanus toxoid conjugate). Clin Diagn Lab Immunol 8 (2001) 1115-1119
22. Anderson E.L., Frey S., Geldmacher K., Radley D., Lee A., Donnelly J., et al. Safety, tolerability and immunogenicity of low dose Haemophilus influenzae type b conjugated to the outer membrane protein complex of Neisseria meningitidis group B. Pediatr Infect Dis J 21 (2002) 350-352
23. Campbell J.D., Lagos R., Levine M.M., and Losonosky G.A. Standard and alternative regimens of Haemophilus influenzae type b conjugate vaccine (polyribosylribitol phosphate-tetanus toxoid conjugate vaccine) elicit comparable antibody avidities in infants. Pediatr Infect Dis J 21 (2002) 822-826
24. Tamm E., Veronese A., Contorni M., Meriste S., Nacci P., and Viviani S. Double-blind study comparing the immunogenicity of a licensed DTwPHib-CRM197 conjugate vaccine (Quattvaxemtrade mark) with three investigational, liquid formulations using lower doses of Hib-CRM197 conjugate. Vaccine 23 (2005) 1715-1719
25. Lagos R., Valenzuela M.T., Levine O.S., Losonsky G.A., Erazo A., Wasserman S.S., et al. Economisation of vaccination against Haemophilus influenzae type b: a randomized trial of immunogenicity of fractional-dose and two-dose regimens. Lancet 351 9114 (1998) 1472-1476
26. Gatchalian S., Reyes M., Bernal N., Lefevre I., David M.-P., Han H.H., et al. A new DTPw-HBV vaccine mixed with PRP-T is immunogenic and safe when administered according to the EPI (Expanded Programme for Immunization) schedule and following Hepatitis B vaccination at birth. Human Vaccines 1 1 (2005) e6-e11
27. Tregnaghi M., Lopez P., Rocha C., Rivera L., David M.P., Ruttimann R., et al. A new DTPw-HB/Hib combination vaccine for primary and booster vaccination of infants in Latin America. Rev Panam Salud Publica 19 3 (2006) 179-188
28. Aristegui J., Usonis V., Coovadia H., Riedeman S., Win K.M., Gatchalian S., et al. Facilitating the WHO expanded program of immunization: the clinical profile of a combined diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b vaccine. Int J Infect Dis 7 (2003) 143-151
29. Ruff T.A., Gertig D.M., Otto B.F., Gust I.D., Sutanto A., Soewarso T.I., et al. Lombok hepatitis B model immunization project: toward universal infant hepatitis B immunization in Indonesia. J Infect Dis 171 (1995) 290-296
30. Hsu H.-M., Lu C.-F., Lee S.-C., Lin S.-R., and Chen D.-S. Seroepidemiologic survey for hepatitis B virus infection in Taiwan: the effect of hepatitis B mass vaccination. J Infect Dis 179 (1999) 367-370
31. DuVernoy T.S., et al. Hypotonic-Hyporesponsive Episodes Reported to the Vaccine Adverse Event Reporting System (VAERS), 1996-1998. Pediatrics 106 4 (2000) e52
32. Hla Hla K., Thein S.A.M., Aye A., Han H.H., Bock H.L., David M.-P., et al. Reactogenicity and immunogenicity profiles of a novel pentavalent DTPw-HepB/Hib vaccine with reduced PRP antigen content: a randomised dose-range trial. Pediatr Infect Dis J 25 (2006) 706-712