The Journal of Pediatrics
Volume 149, Issue 5 , Pages 603-610.e1 , November 2006

Safety of reduced-antigen-content tetanus–diphtheria–acellular pertussis vaccine in adolescents as a sixth consecutive dose of acellular pertussis–containing vaccine

  • Fred Zepp, MD

      Affiliations

    • Drs. Zepp, Knuf, and Habermehl have acted as consultants for GlaxoSmithKline/other pharmaceutical companies and have received travel grants or honoraria paid by healthcare companies within the past 3 years. None of the other authors in this paper have declared conflicts of interest.
    • Corresponding Author InformationReprint requests: Prof F. Zepp, Children’s Hospital, Johannes-Gutenberg-University, Langenbeckstrasse 1, 55101 Mainz, Germany.
    • ,
  • Markus Knuf, MD

      Affiliations

    • Drs. Zepp, Knuf, and Habermehl have acted as consultants for GlaxoSmithKline/other pharmaceutical companies and have received travel grants or honoraria paid by healthcare companies within the past 3 years. None of the other authors in this paper have declared conflicts of interest.
    • ,
  • Pirmin Habermehl, MD

      Affiliations

    • Drs. Zepp, Knuf, and Habermehl have acted as consultants for GlaxoSmithKline/other pharmaceutical companies and have received travel grants or honoraria paid by healthcare companies within the past 3 years. None of the other authors in this paper have declared conflicts of interest.
    • ,
  • Wilma Mannhardt-Laakmann, MD
    • ,
  • Barbara Howe, MD

      Affiliations

    • Drs Howe and Friedland are employees of GlaxoSmithKline and report ownership of equity or stock options.
    • ,
  • Leonard R. Friedland, MD

      Affiliations

    • Drs Howe and Friedland are employees of GlaxoSmithKline and report ownership of equity or stock options.

Received 21 November 2005 ,Revised 15 March 2006 ,Accepted 9 June 2006.

References 

  1. Centers for Disease Control and Prevention. Pertussis: United States, 2001-2003. MMWR 2005;54:1283-6.
  2. Guris D, Strebel PM, Bardenheier B, Brennan M, Tachdjian R, Finch E, et al. Changing epidemiology of pertussis in the United States: increasing reported incidence among adolescents and adults, 1990-1996. Clin Infect Dis. 1999;28:1230–1237
  3. Pertussis Surveillance Report: 8/12/05. Bacterial Vaccine Preventable Diseases Branch, National Immunization Program, Centers for Disease Control and Prevention. 2004: Atlanta, GA (final data).
  4. Edwards KM. Overview of pertussis: focus on epidemiology, sources of infection, and long term protection after infant vaccination. Pediatr Infec Dis J. 2005;24:S104–S108
  5. US Food and Drug Administration Center for Biologics Evaluation and Research. Product approval information: licensing action. [updated 2005 May 17; 2005 June 10]. Available from http://www.fda.gov/cber/products/tdapgla050305.htm
  6. Rennels MB, Deloria MA, Pichichero ME, Losonsky GA, Englund JA, Meade BD, et al. Extensive swelling reactions occurring after booster doses of acellular pertussis-tetanus-diphtheria vaccines. Pediatrics. 2000;105;Available from http://www.pediatrics.org/cgi/content/full/105/1/e12
  7. GlaxoSmithKline Biologicals. Rixensart, Belgium. Infanrix® package insert.
  8. Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices and the American Academy of Family Physicians. MMWR Morb Mortal Wkly Rep. 2002;51(RR-2):1–35
  9. Keitel WA, Muenz LR, Decker MD, Englund JA, Mink CM, Blumberg DA, et al. A randomized clinical trial of acellular pertussis vaccines in healthy adults: dose-response comparisons of 5 vaccines and implications for booster immunization. J Infect Dis. 1999;180:397–403
  10. Pichichero ME, Blatter MM, Kennedy WA, Hedrick J, Descamps D, Friedland LR. Acellular pertussis vaccine booster combined with diphtheria and tetanus toxoids for adolescents. Pediatrics. 2006;117:1084–1093
  11. Tran Minh NN, He Q, Ramalho A, Kaufhold A, Viljanen MK, Arvilommi H, et al. Acellular vaccines containing reduced quantities of pertussis antigens as a booster in adolescents. Pediatrics. 1999;104;Available from http://www.pediatrics.org/cgi/content/full/104/6/e70
  12. Theeten H, Van Damme P, Hoppenbrouwers K, Leback E, Sokal E, Wolter J, et al. Effects of lowering the aluminium content of a dTap vaccine on its immunogenicity and reactogenicity when given as a booster to adolescents. Vaccine. 2005;23:1515–1521
  13. Pichichero ME, Rennels MB, Edwards KM, Blatter MM, Marshall GS, Bologa M, et al. Combined tetanus, diphtheria, and 5-component pertussis vaccine for use in adolescents and adults. JAMA. 2005;293:3003–3011
  14. GlaxoSmithKline Biologicals. Rixensart, Belgium. Boostrix® package insert.
  15. GlaxoSmithKline Biologicals. Rixensart, Belgium. Havrix® package insert.
  16. Saenger R, Wolter J, Schuerman L. A reduced-antigen diphtheria-tetanus-acellular pertussis-IPV vaccine for booster vaccination of 4 to 8 year old children. 21stAnnual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). April 9-11, 2003, Taormina, Sicily. Abstract No. 247.
  17. Woo EJ, Burwen DR, Gatumu SN, Ball R. Vaccine Adverse Event Reporting System Working Group: consecutive dose of a five-component acellular pertussis-based combination vaccine. Clin Infect Dis. 2003;37:351–358
  18. Rennels MB. Extensive swelling reactions occurring after booster doses of diphtheria-tetanus-acellular pertussis vaccines. Semin Pediatr Infect Dis. 2003;14:196–198
  19. Tozzi AE, Anemona A, Stefanelli P, Salmaso S, Ciofi degli Atti M, Mastrantonio P, et al. Reactogenicity and immunogenicity at preschool age of a booster dose of two three-component diphtheria-tetanus-acellular pertussis vaccines in children primed in infancy with acellular vaccines. Pediatrics. 2001;107;Available from http://www.pediatrics.org/cgi/content/full/107/2/e25
  20. Pichichero ME. Acellular pertussis vaccines: towards an improved safety profile. Drug Saf. 1996;15:311–324
  21. Pichichero ME, Edwards KM, Anderson EL, Rennels M, Englund J, Yerg D, et al. Safety and immunogenicity of six acellular pertussis vaccines and one whole-cell pertussis vaccine given as a fifth dose in four- to six-year-old children. Pediatrics. 2000;105;Available from http://www.pediatrics.org/cgi/content/full/105/1/e11
  22. Skowronski DM, Remple VP, Macnabb J, Pielak K, Patrick D, Halperin S, et al. Injection-site reactions to booster doses of acellular pertussis vaccine: rate, severity, and anticipated impact. Pediatrics. 2003;112;Available from http://www.pediatrics.org/cgi/content/full/112/6/e453
  23. Centers for Disease Control. Use of diphtheria toxoid-tetanus toxoid-acellular pertussis vaccine as a five-dose series: supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2000;49(RR-13):1–8
  24. Campins-Marti M, Cheng HK, Forsyth K, Guiso N, Halperin S, Huang LM, et al. Recommendations are needed for adolescent and adult pertussis immunisation: rationale and strategies for consideration. Vaccine. 2001;20:641–646
  25. Hewlett EL, Edwards KM. Clinical practice: pertussis: not just for kids. N Engl J Med. 2005;352:1215–1222
  26. American Academy of Pediatrics, Committee on Infectious Diseases. Prevention of pertussis among adolescents: recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine. Pediatrics. 2006;117:965–978

 Supported by GlaxoSmithKline Biologicals (study No. 100406).

 This clinical trial was registered at www.clinicaltrials.gov (No. NCT00263679).

PII: S0022-3476(06)00553-1

doi: 10.1016/j.jpeds.2006.06.016

The Journal of Pediatrics
Volume 149, Issue 5 , Pages 603-610.e1 , November 2006

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