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References:


  1. Pentacel vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2009.
  2. Centers for Disease Control and Prevention (CDC). Recommended immunization schedule for persons aged 0 through 6 years-United States, 2011. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6005a6.htm. Accessed June 17, 2011.
  3. Food and Drug Administration. Pentacel®: DTaP-IPV/Hib Combined (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus b conjugate [tetanus toxoid conjugate] vaccine combined). VRBPAC Briefing Document. http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4275B1-01.pdf. Accessed April 14, 2011.
  4. American Academy of Pediatrics. Combination vaccines for childhood immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP). Pediatrics. 1999;103:1064-1077.
  5. CDC. Estimated vaccination coverage with individual vaccines and selected vaccination series before 24 months of age by state and local area US, National Immunization Survey, Q/1/2009-Q4/2009. http://www2a.cdc.gov/nip/coverage/nis/nis_iap2.asp?fmt=v&rpt= tab09_24mo_iap&qtr=Q1/2009-Q4/2009. Accessed April 14, 2011.
  6. CDC. Licensure of a diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, and Haemophilus b conjugate vaccine and guidance for use in infants and children. MMWR. 2008:57(39):1079-1080.
  7. DAPTACEL vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2008.
  8. Decker MD, Edwards KM, Bradley R, Palmer P. Comparative trial in infants of four conjugate Haemophilus influenzae type b vaccines. J Pediatr. 1992;120:184-189.
  9. Granoff DM, Anderson EL, Osterholm MT, et al. Differences in the immunogenicity of three Haemophilus influenzae type b conjugate vaccines in infants. J Pediatr. 1992;121:187-194.
  10. Greenberg DP, Lieberman JM, Marcy SM, et al. Enhanced antibody responses in infants given different sequences of heterogeneous Haemophilus influenzae type b conjugate vaccines. J Pediatr. 1995;126:206-211.
  11. Sanofi Pasteur Limited. Data on file (North American Sales Through 12/5/2009). December 2009. MKT18811.
  12. Omer SB, Salmon DA, Orenstein WA, deHart PM, Halsey N. Vaccine refusal, mandatory immunization, and the risks of vaccine-preventable diseases. N Engl J Med. 2009;360:1981-1988.
  13. CDC. Updated recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding routine poliovirus vaccination. MMWR. 2009:58(30):829-830.
  14. Sanofi Pasteur. Data on file (Sharon Humiston Interview). 2009. MKT17452.
  15. CDC. Data on File (2009 Final Pertussis Surveillance Report, 9/10/10). September 2010. MKT20796.
  16. CDC. Pertussis. In: Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W, Wolfe C, Hamborsky J, McIntyre L, eds. 11th ed. Washington, DC: Public Health Foundation, 2009:199-216.
  17. Bisgard KM, Pascual FB, Ehresmann KR, et al. Infant pertussis: who was the source? Pediatr Infect Dis J. 2004;23(11):985-989.
  18. CDC. Haemophilus influenzae serotype b (Hib) disease. http://www.cdc.gov/ncidod/dbmd/diseaseinfo/haeminfluserob_t.htm. Accessed April 14, 2011.
  19. CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). 2011. MMWR. 2011;60(2):1-61.
  20. Sanofi Pasteur. Data on file (Coding and Billing Sheet). June 2008. MKT12802.
  21. Immunization Action Coalition. Don’t be guilty of these errors in vaccine storage and handling.http://www.immunize.org/catg.d/p3036.pdf. Accessed April 14, 2011.
  22. Zhou F, Santoli J, Messonnier ML, et al. Economic evaluation of the 7-vaccine routine childhood immunization schedule in the United States, 2001. Arch Pediatr Adolesc Med. 2005;159:1136-1144.
  23. CDC. National, state, and local area vaccination coverage among children aged 19-35 months – United States, 2008. MMWR. 2009;58(33):921-926.
  24. American Academy of Pediatrics. Facts for parents about vaccine safety from the American Academy of Pediatrics. http://www.aap.org/advocacy/releases/autismparentfacts.htm. Accessed April 14, 2011.
  25. Glanz JM, McClure DL, Magid DJ, et al. Parental refusal of pertussis vaccination is associated with an increased risk of pertussis infection in children. Pediatrics. 2009;123:1446-1451.
  26. CDC. Diphtheria. In: Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W, Wolfe C, Hamborsky J, McIntyre L, eds. 11th ed. Washington, DC: Public Health Foundation, 2009:59-70.
  27. CDC. Tetanus. In: Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W, Wolfe C, Hamborsky J, McIntyre L, eds. 11th ed. Washington, DC: Public Health Foundation, 2009:273-282.
  28. CDC. Vaccines & Immunizations: Basics and common questions: what would happen if we stopped vaccinations? http://www.cdc.gov/vaccines/vac-gen/whatifstop.htm. Accessed April 14, 2011.
  29. CDC. Polio. In: Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W, Wolfe C, Hamborsky J, McIntyre L, eds. 11th ed. Washington, DC: Public Health Foundation, 2009:231-244.
  30. CDC. Wild poliovirus type 1 and type 3 importations – 15 countries, Africa, 2008-2009. MMWR. 2009;58(14):257-362.
  31. CDC. Vaccines & Immunizations. Vaccines and preventable diseases: diphtheria in-short. http://www.cdc.gov/vaccines/vpd-vac/diphtheria/in-short-both.htm. Accessed April 14, 2011.
  32. CDC. Vaccines Immunizations. Vaccines and preventable diseases: tetanus disease in-short (lockjaw). http://www.cdc.gov/vaccines/vpd-vac/tetanus/in-short-both.htm. Accessed April 14, 2011.
  33. CDC. Vaccines & Immunizations. Vaccines and preventable diseases: Hib in-short. http://www.cdc.gov/vaccines/vpd-vac/hib/in-short-adult.htm. Accessed April 14, 2011.
  34. CDC. Vaccines & Immunizations. Vaccines and preventable diseases: polio disease in-short. http://www.cdc.gov/vaccines/vpd-vac/polio/in-short-both.htm. Accessed April 14, 2011.
  35. Landers SJ. Landmark ruling finds no link between vaccine and autism. American Medical News. http://www.ama-assn.org/amednews/2009/03/02/hll20302.htm. Accessed April 14, 2011 to April 15, 2011.

Indication
Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b. Pentacel vaccine is approved for use as a 4-dose series in children 6 weeks through 4 years of age (prior to fifth birthday).


Safety Information
The most common local and systemic adverse reactions to Pentacel vaccine include injection site redness, swelling, and tenderness; fever, fussiness, and crying. Other adverse reactions may occur. Known systemic hypersensitivity reaction to any component of Pentacel vaccine or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances are contraindications to vaccination.

The decision to give Pentacel vaccine should be based on the potential benefits and risks; if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid; or if adverse events have occurred in temporal relation to receipt of pertussis-containing vaccine. Encephalopathy within 7 days of administration of a previous dose of a pertussis-containing vaccine or a progressive neurologic disorder is a contraindication. Vaccination with Pentacel vaccine may not protect all individuals.

Before administering Pentacel vaccine, please see the full Prescribing Information.

Pentacel vaccine is manufactured by Sanofi Pasteur Limited and Sanofi Pasteur SA and distributed by Sanofi Pasteur Inc.