Combination vaccines in the South African setting

Vaccine

Volumn 30, Issue SUPPL.3, 2012, Pages

  Visser, Adele ^a   Hoosen, Anwar ^a  

^a UNIVERSITY OF PRETORIA   (South Africa)

Author keywords

Combination vaccines; Component vaccines; Expanded programme for immunisation; Inter changeability of vaccines; Vaccine safety

Indexed keywords

DIPHTHERIA PERTUSSIS POLIOMYELITIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B VACCINE; DIPHTHERIA PERTUSSIS TETANUS VACCINE; HEPATITIS A HEPATITIS B VACCINE; HEPATITIS B VACCINE; LIVE VACCINE; MEASLES MUMPS RUBELLA VACCINE; POLIOMYELITIS VACCINE; VACCINE;

DRUG COST; DRUG EFFICACY; DRUG LEGISLATION; DRUG SAFETY; HEALTH CARE COST; HUMAN; LICENSING; PATIENT COMPLIANCE; PRIORITY JOURNAL; REVIEW; SOUTH AFRICA; UNITED STATES; VACCINATION; VACCINATION REACTION;

DIPHTHERIA-TETANUS-PERTUSSIS VACCINE; HAEMOPHILUS VACCINES; HEALTH POLICY; HUMANS; IMMUNIZATION PROGRAMS; IMMUNIZATION SCHEDULE; POLIOVIRUS VACCINE, INACTIVATED; SOUTH AFRICA; VACCINATION; VACCINES, COMBINED; VACCINES, CONJUGATE;

EID: 84865637631     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.05.001     Document Type: Review

References (98)

1. Global Alliance for Vaccines and Immunization. [accessed 20.10.11]. http://www.gavialliance.org/about/mission/impact/.
2. UNICEF. [accessed 28.12.11]. http://www.childinfo.org/hiv_aids.html.
3. Koslap-Petraco M., Judelsohn R. Societal impact of combination vaccines: experiences of physicians, nurses, and parents. J Pediatr Health Care 2008, 22:300-309.
4. Pertussis. Epidemiology and prevention of vaccine-preventable diseases 2006, 1-44. CDC, Public Health Foundation, Washington, DC. W. Atkinson, J. Hamborsky, C. Wolf (Eds.).
5. Combination vaccines for childhood immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrica (AAP) and the American Academy of Family Physicians (AAFP). MMWR Morb Mortal Wkly Rep 1999, 1-15. CDC.
6. Dagan R., Botujansky C., Watemberg N. Safety and immunogenicity in young infants of Haemophilus b-tetanus protein conjugate vaccine, mixed in the same syringe with diphtheria-tetanus-enhanced inactivated poliovirus vaccine. Pediatr Infect Dis J 1994, 13:356-362.
7. Decker M., Edwards K. Combination vaccines: problems and promise. J Pediatr 2000, 137:291-295. [editorial].
8. Halsey N., Blatter M., Bader G. Inactivated poliovirus vaccine alone or sequential inactivated and oral poliovirus vaccine in 2-, 4-, and 6-month-old infant with combination Haemophilus influenzae type b/hepatitis B vaccine. Pediatr Infect Dis J 1997, 16:675-679.
9. Marcy S. Pediatric combination vaccines: their impact on patients, providers, managed care organizations, and manufacturers. Am J Manag Care 2003, 9:314-320.
10. Decker M., Edwards K., Bogaerts H. Combination vaccines. Vaccines 2008, 1069-1101. Elsevier, [Chapter 38]. 5th ed. S. Plotkin, W. Orenstein, P. Offit (Eds.).
11. Halsey N. Safety of combination vaccines: perception versus reality. Pediatr Infect Dis J 2001, 20:S40-S44.
12. Woodkin K., Rodewald L., Humiston S., Carges M., Schaffer S., Szilagyi P. Physician and parent opinions: are children becoming pincushions from immunizations?. Arch Pediatr Adolesc Med 1995, 149:845-849.
13. Corbel M. Control testing of combined vaccines: a considerations of potential problems and approaches. Biologicals 1994, 22:353-360.
14. Anthony B. FDA perspective on regulatory issues in vaccine development. Combined vaccines and simultaneous administration: current issues and perspectives 1995, 10-16. Annals of the New York Academy of Sciences, New York. J. Williams, K. Goldenthal, D. Burns, B. Lewis (Eds.).
15. Insel R. Potential alterations in immunogenicity by combining or simultaneous administering vaccine components. Combined vaccines and simultaneous administration: current issues and perspectives 1995, 35-47. Annals of the New York Academy of Sciences, New York. J. Williams, K. Goldenthal, D. Burns, B. Lewis (Eds.).
16. Gellin B., Maibach E., Marcuse E. Do parents understand immunizations? A national telephone survey. Pediatrics 2000, 106:1097-1102.
17. Meyerhoff A., Jacoba R., Greenberg D., Yagoda B., Castles C. Clinicians satisfaction with vaccination visits and the role of multiple injections, results from the COVISE study (Combination Vaccines Impact on Satisfaction and Epidemiology). Clin Pediatr (Phila) 2004, 43:87-93.
18. Meyerhoff A., Jocobs R. Do too many shots due lead to missed vaccination opportunities? Does it matter?. Prev Med 2005, 41:540-544.
19. Hull B., McIntyre P. Timeliness of childhood immunisation in Australia. Vaccine 2006, 24:4403-4408.
20. Freed G., Cowan A., Clark S., Santoli J., Bradley J. Use of a new combined vaccine in pediatric practices. Pediatrics 2006, 118:e251-e257.
21. Kalies H., Grote V., Verstaeten V., H.Essel L., Schmitt H., Kries Rv. The use of combination vaccines had improved timeliness of vaccination in children. Pediatr Infect Dis J 2006, 25:507-512.
22. Goldfarb N., Patel N., Clarke J. Improving quality by encouraging providers to use pediatric combination vaccines. Manag Care 2005, 6:3-12.
23. World development report 1993 1993, International Band of Reconstruction and Development, Washington, DC. Development IBoRa (Ed.).
24. State of the world's vaccines and immunization 2012, World Health Organization, [accessed 28.02.12]. http://whqlibdoc.who.int/publications/2009/9789241563864_eng.pdf.
25. Mahoney R., Ramachandran S., Xu Z. The introduction of new vaccines into developing countries II. Vaccine financing. Vaccine 2000, 18:2625-2635.
26. Blecher M., Meheus F., Kollipara A., Hecht R., Cameron N., Pillay Y. Financing vaccinations-the South African experience. Vaccine 2012, 30(Suppl. 3):C79-C86.
27. Lydon P., Levine R., Makinen M., Brenzel L., Mitchell V., Milstien J., et al. Introducing new vaccines in the poorest countries: what did we learn from the GAVI experience with financial sustainability?. Vaccine 2008, 26:6706-6716.
28. Phoshoko S. Vaccine costing in SA, personal communication.
29. Hersh B., Tambini G., Nogueira A., Carrasco P., Quadros Cd. Review of regional measles surveillance data in the Americas, 1996-99. Lancet 2000, 355:1943-1948.
30. Edwards K., Decker M. Combination vaccines: hopes and challenges. Pediatr Infect Dis J 1994, 13:13.
31. Fabio J.D., Quadros Cd Considerations for combination vaccine development and use in the developing world. Clin Infect Dis 2001, 33:S340-S345.
32. Hadler S., Dietz V., Okwo-Bele J., Cutts F. Immunization in developing countries. Vaccines 2008, 1542. Saunders Elsevier. 5th ed. S. Plotkin, W. Orenstein, P. Offit (Eds.).
33. World Health Organization. Expanded programme on immunization (EPI). [accessed 25.01.12]. http://www.who.int/immunization_delivery/en/.
34. Dicko M., Oni A., Ganivet S., Kone S., Pierre L., Jacquet B. Safety of immunization in Africa: not simply a problem of logistics. Bull World Health Organ 2000, 78:163-169.
35. Halsey N. Limiting infant exposure to thimerosal in vaccines and other sources of mercury. JAMA 1999, 282:1763-1766.
36. Pichichero M., Latiolais T., Bernstein D. Vaccine antigen interaction after a combination diphtheria-tetanus-toxoid-acellular pertussis/purified capsular polysaccharide of Haemophilus infulenzae type b-tetanus toxoid vaccine in two-, four- and six-month-old infants. Pediatr Infect Dis J 1997, 16:863-870.
37. Schmitt H., Zepp F., Muschenborn S. Immunogenicity and reactogenicity of a Haemophilus influenzae type b tetanus conjugate vaccine when administred separately or mixed with concomittant diphtheria-tetanus-toxoid and aceullar pertussis vaccine for primary and for booster immunization. Eur J Pediatr 1998, 157:208-214.
38. Nakayama T., Aizawa C., Kuno-Sakai H. A clinical analysis of gelatin allergy and determination of its causal relationship to the previous administration of gelatin-containing acellular pertussis vaccine combined with diphtheria and tetanus toxoids. J Allergy Clin Immunol 1999, 103:321-325.
39. Berkovich S., Starr S. Effects of live type 1 poliovirus vaccine and other viruses on the tuberculin test. N Engl J Med 1966, 274:67-72.
40. Brickman H., Beardry P., Marks M. The timing of tuberculin tests in relation to immunization with live viral vaccines. Pediatrics 1975, 55:392-396.
41. Halsey N., Combination vaccines: defining and addressing current safety concerns Clin Infect Dis 2001, 33:S312-S318.
42. Immunologic reactions. Adverse events associated with childhood vaccines: evidence bearing on causality 1993, 59-66. Institute of Medicine, Division of Health Promotion and Disease Prevention, National Academy Press, Washington, DC. K. Stratton, C. Howe, R. Johnston (Eds.).
43. Pickering L., Siegelman M. Lymphoid tissues and organs. Fundamental immunology 1999, 479-532. Lippincott-Raven, Philadelphia. 4th ed. W. Paul (Ed.).
44. Guidance for industry for the evaluation of combination vaccines for preventable disease: production, testing and clinical studies. Fed Reg 1997, 62:17624-17625. Center for Biologics Evaluation and Research, US Food and Drug Administration.
45. Horne A., Lachenbruch P., Getson P., Hsu H. Analysis of studies to evaluate the immune response to combination vaccines. Clin Infect Dis 2001, 33:S306-S311.
46. Ball L., Falk L., Horne A., Finn T. Evaluating the immune response to combination vaccines. Clin Infect Dis 2001, 33:S299-S305.
47. Halsey N. A perspective on combination vaccines. Pediatr Infect Dis J 1998, 17:653-654.
48. Harrison L., Tajkowski C., Croll J. Postlicensure effectiveness of the Haemophilus influenzae type b polysaccharide-Neisseria meningitidis outer membrane protein complex conjugate vaccine among Navajo children. J Pediatr 1994, 125:571-576.
49. US Code of Federal Regulations. Title 21, part 601.25(d)(2). Washington, DC: US Government Printing Office; 2001.
50. US Code of Federal Regulations. Title 21, part 610.17. Washington, DC: US Government Printing Office; 2001.
51. US Code of Federal Regulations. Title 21, part 601.25(d)(4). Washington, DC: US Government Printing Office; 2001.
52. US Code of Federal Regulations. Title 21, part 312.21. Washington, DC: US Government Printing Office; 2001.
53. Kuter B., Brown M., Hartzel J., Williams W., EvesiKaren A., Black S., et al. Safety and immunogenicity of a combination measles, mumps, rubella and varicella vaccine (ProQuad). Hum Vaccin 2006, 2:205-214.
54. Shinefield H., Black S., Staehle B., Adelman T., Ensor K., Ngai A., et al. Safety, tolerability and immunogenicity of concomitant injections in separate locations of M-M-RII, VARIVAX and TETRAMUNE in healthy children vs. concomitant injections of M-M-RII and TETRAMUNE followed six weeks later by VARIVAX. Pediatr Infect Dis J 1998, 17:980-985.
55. Schmitt H., Steul K., Borkowski A., Ceddia F., Ypma E., Knuf M. Two versus three doses of a meningococcal C conjugate vaccine concomitantly administered with a hexavalent DTaP-IPV-HBV/Hib vaccine in healthy infants. Vaccine 2008, 26:2242-2252.
56. Tejedor J., Moro M., Ruiz-Contreras J., Castro J., Gómez-Campderá J., Navarro M., et al. Immunogenicity and reactogenicity of primary immunization with a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type B vaccine coadministered with two doses of a meningococcal C-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J 2006, 25:713-720.
57. Reisinger K., Brown M., Xu J., Sullivan B., Marshall G., Nauert B., et al. A combination measles, mumps, rubella, and varicella vaccine (ProQuad) given to 4- to 6-year-old healthy children vaccinated previously with M-M-RII and Varivax. Pediatrics 2006, 117:265.
58. Arístegui J., Dal-Ré R., Díez-Delgado J., Marés J., Casanovas J., García-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, 21:3593-3600.
59. Pertussis vaccination: use of acellular pertussis vaccines among infants and young children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1997, 46:1-25. CDC.
60. Granoff D., Rappuoli R. Are serological responses to acellular pertussis antigens sufficient criteria to ensure that new combination vaccines are effective for prevention of disease?. Dev Biol Stand 1997, 89:379-389.
61. Clements-Mann M. Lessons for AIDS vaccine development from non-AIDS vaccines. AIDS Res Hum Retroviruses 1998, 14:S197-S203.
62. Edsall G., Elliott M., Peebles T., Panaro R., Eldred M. Excessive use of tetanus toxoid boosters. JAMA 1967, 202:111-113.
63. Peebles T., Levine L., Eldred M., Edsall G. Tetanus-toxoid emergency boosters: a reappraisal. N Engl J Med 1969, 280.
64. Jacobs R., Lowe R., Lanier B. Adverse reactions to tetanus toxoid. JAMA 1982, 247:40-42.
65. Baraff L., Cody C., Cherry J. DTP-associated reactions: an analysis by injection site, manufacturer, prior reactions, and dose. Pediatrics 1984, 73:31-36.
66. Jones A., Melville-Smith M., Watkins J., Seagroatt V., Rice L., Sheffield F. Adverse reactions in adolescents to reinforcing dose of plain and adsorbed tetanus vaccines. Community Med 1985, 7:99-106.
67. Tetanus (Lockjaw). 1997 Red Book: report of the Committee on Infectious Diseases 1997, 518-523. American Academy of Pediatrics, American Academy of Pediatrics, Elk Grove Village, IL. 24th ed. G. Peter (Ed.).
68. Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventative measures. Recommendations of the Immunization Practice Advisory Committee (ACIP). MMWR 1991, 40:1-28. CDC.
69. Sackett D., Rosenberg W., Gray J., Haynes R., Richardson W. Evidence based medicine: what it is and what it isn't. BMJ 1996, 312:71-72.
70. Pneumococcal infections. 1997 Red Book: report of the Committee on Infectious Diseases 1997, 410-419. American Academy of Pediatrics, American Academy of Pediatrics, Elk Grove Village, IL. 24th ed. G. Peter (Ed.).
71. World Health Organization. [accessed 25.04.12]. http://www.int/countries/en/.
72. Ntombenhle J., Cameron N. The decision making process on new vaccine introduction in South Africa. Vaccine 2012, 30(Suppl. 3):C9-C13.
73. Madhi S., Cutland C., Jones S., Groome M., Ortiz E. One-year post-primary antibody persistence and booster immune response to a DTaP-IPV//PRP-T vaccine (Pentaxim) given at 18-19 months of age in South African children primed at 6, 10 and 14 weeks of age with the same vaccine. S Afr J Med 2011, 101:879-883.
74. Madhi S., Cutland C., Jones S., Groome M., Ortiz E. Immunogenicity and safety of an acellular pertussis, diphtheria, tetanus, inactivated poliovirus, Hib-conjugate combined vaccine (Pentaxim) and monovalent hepatitis B vaccine at 6, 10 and 14 weeks of age in infants in South Africa. S Afr J Med 2011, 101:126-131.
75. Ngcobo N. The impact of the immunisation programme on vaccine-preventable diseases in South Africa: a review of progress over a 10- to 15-year period. S Afr J Epidemiol Infect 2008, 23:9-13.
76. Schoub B. Introduction of inactivated poio vaccine (IPV) into the routine immunization in South Africa. Vaccine 2012, 30(Suppl. 3):C35-C37.
77. Griffiths U., Botham L., Schoub B. The cost-effectiveness of alternative polio immunization policies in South Africa. Vaccine 2006, 24:5670-5678.
78. National Institutes for Communicable Diseases. Polio paralyses child. [accessed 12.04.12]. http://www.nicd.ac.za/%3Fpage=alerts%26id.
79. National Institute for Communicable Diseases. Annual review 2010-2011. [accessed 12.04.12]. http://www.nicd.ac.za/assets.files/.
80. Von Gottberg A., De Gouveia I., Madhi S. Impact of conjugate Haemophilus influenzae type b (Hib) vaccine introduction in South Africa. Bull World Health Organ 2006, 84:811-818.
81. Von Gottberg A., Cohen C., Whiteloaw A., Chhagan M., Flannery B., Cohen A., et al. Invasive disease due to Haemophilus influenzae serotype b ten years after routine vaccination, South Africa, 2003-2009. Vaccine 2012, 30:565-571.
82. Huebner R., Klugman K., Matai U., Eggers R., Hussey G. Laboratory surveillance for Haemophilus influenzae type b, meningococcal and pneumococcal disease. Haemophilus Surveillance Working Group. S Afr Med J 1999, 89:924-925.
83. Hussey G., Hitchcock J., Schaaf H., Hanslo G.C., Schalkwyk Ev., Pitout J., et al. Epidemiology of invasive Haemophilus influenzae infections in Cape Town, South Africa. Ann Trop Paediatr 1994, 14:97-103. [Abstract].
84. Barnighausen T., Bloom D., Canning D., Friedman A., Levine O., O'Brien J., et al. Rethinking the benefits and costs of childhood vaccination: the example of the Haemophilus influenzae type b vaccine. Vaccine 2011, 29:2371-2380.
85. John T., Muliyil J. Introducing pentavalent vaccine in EPI in India: issues involved. Indian J Med Res 2010, 132:450-455.
86. Madhavi Y., Raghuram N. Pentavalent & other new combination vaccines: solution in search of problems. Indian J Med Res 2010, 132:456-457.
87. SAVIC. [accessed 28.12.11]. http://www.savic.ac.za/news/newsarticles.php.
88. Du Toit G., Weinberg E. Egg allergy and MMR vaccination. S Afr J Med 2003, 93:113-114.
89. Cameron N. When should be introduce a combination measles-mumps-(MMR) vaccine into the national childhood expanded immunization programme in South Africa?. Vaccine 2012, 30(Suppl. 3):C58-C60.
90. Corcoran C., Hardie D. Seroprevalence of rubella antibodies among antenatal patients in the Western Cape. S Afr J Med 2005, 95:688-690.
91. Robertson S., Cutts F., Samuel R., Diaz-Ortega J. Control of rubella and congenital rubella syndrome (CRS) in developing countries. Part 2. Vaccination against rubella. Bull World Health Org 1997, 75:69-80.
92. Fonn S., Sartorius B., Levin J., Likibi M. Immunisation coverage estimates by cluster sampling survey of children (aged 12-23 months) Gauteng province, 2003. S Afr J Epidemiol Inf 2006, 21:164-169.
93. Paediatric Group. [accessed 21.04.12]. http://www.paediatrician.co.za/.
94. Mail and Guardian. Forty million South African without medical aid. [accessed 21.04.12]. http://www.mg.co.za/article/2009-07-07-forty-million-south-africans-without-medical-aid.
95. Schoub B., Ngcobo N., Madhi S. The National Advisory Group on Immunization (NAGI) of the Republic of South Africa. Vaccine 2010, 28S:A31-A34.
96. Madhi S., Puren A., Kuwanda L., Jassat W., Jones S., Little T., et al. Long-term immunogenicity and efficacy of a 9-valent conjugate pneumococcal vaccine in human immunodeficient virus infected and non-infected children in the absence of a booster dose of vaccine. Vaccine 2007, 25:2451-2457.
97. Fadnes L., Jackson D., Engebretsen I., Zembe W., Sanders D., Sommerfelt H., et al. Vaccination coverage and timeliness in three South African areas: a prospective study. BMC Public Health 2011, 11:404-414.
98. Gentile A., Bhutta Z., Bravo L., Samy A., Garcia R., Hoosen A., et al. Pediatric disease burden and vaccination recommendations: understanding local differences. Int J Infect Dis 2010, 14:e649-e658.