Fully liquid DTaP-IPV-Hib pediatric combination vaccine (Pediacel): a review of 18 years of clinical experience

References

• Plotkin SL, Plotkin SA. A short history of vaccination. In: Vaccines, 6th Edition. Plotkin SA, Orenstein WA, Offit P, Editors Saunders; Philadelphia, PA, USA: 2012. 1-13
   Google Scholar
• Centers for Disease Control and Prevention (CDC). 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). MMWR Morb Moral Wkly Rep 1999;48(No. RR-5):1-15
   PubMedGoogle Scholar
• World Health Organization (WHO) Website GIVS: global immunization vision and strategy 2006-2015. 2013
   Google Scholar
• Frampton JE. DTaP(5)-IPV-Hib vaccine (Pediacel®). Paediatr Drugs 2011;13(6):401-15
   PubMedGoogle Scholar
• Pichichero ME, Detora LM, Johnson DR. An adolescent and adult formulation combined tetanus, diphtheria and five-component pertussis vaccine. Expert Rev Vaccines 2006;5(2):175-87
   PubMed Web of Science ®Google Scholar
• White C, Halperin SA, Scheifele DW. Pediatric combined formulation DTaP-IPV/Hib vaccine. Expert Rev Vaccines 2009;8(7):831-40
   PubMed Web of Science ®Google Scholar
• Black S, Greenberg DP. A combined diphtheria, tetanus, five-component acellular pertussis, poliovirus and Haemophilus influenzae type b vaccine. Expert Rev Vaccines 2005;4(6):793-805
   PubMed Web of Science ®Google Scholar
• Halperin SA. Prevention of pertussis across the age spectrum through the use of the combination vaccines PENTACEL and ADACEL. Expert Opin Biol Ther 2006;6(8):807-21
   PubMed Web of Science ®Google Scholar
• Dhillon S, Keam SJ. DTaP-IPV/Hib vaccine (Pentacel). Paediatr Drugs 2008;10(6):405-16
   PubMedGoogle Scholar
• Vidor E, Plotkin SA. Immunogenicity of a two-component (PT & FHA) acellular pertussis vaccine in various combinations. Hum Vaccin 2008;4(5):328-40
   PubMed Web of Science ®Google Scholar
• Plotkin SA, Liese J, Madhi SA, Ortiz E. A DTaP-IPV//PRP approximately T vaccine (Pentaxim): a review of 16 years’ clinical experience. Expert Rev Vaccines 2011;10(7):981-1005
   PubMed Web of Science ®Google Scholar
• Vidor E, Plotkin SA. Poliovirus vaccine – inactivated. In: Vaccines, 6th edition. Plotkin SA, Orenstein WA, Offit P, editors. Saunders; Philadelphia, PA, USA: 2012. 573-97
   Google Scholar
• Chandran A, Watt JP, Santosham M. Haemophilus influenzae vaccines. In: Vaccines, 6th edition. Plotkin SA, Orenstein WA, Offit P, editors. Saunders; Philadelphia, PA, USA: 2012. 167-82
   Google Scholar
• Tiwari TSP, Wharton M. Diphtheria toxoid. In: Vaccines, 6th edition. Plotkin SA, Orenstein WA, Offit P, editors. Saunders; Philadelphia, PA, USA: 2012. 153-66
   Google Scholar
• Roper MH, Wassilak SGF, Tiwari TSP, Orenstein WA. Tetanus toxoid. In: Vaccines, 6th edition. Plotkin SA, Orenstein WA, Offit P, editors. Saunders; Philadelphia, PA, USA: 2012. 746-72
   Google Scholar
• Sutter RW, Pallansch MA, Sawyer LA, et al. Defining surrogate serologic tests with respect to predicting protective vaccine efficacy: poliovirus vaccination. Ann N Y Acad Sci 1995;754:289-99
   PubMed Web of Science ®Google Scholar
• Vidor E, Hoffenbach A, Fletcher MA. Haemophilus influenzae type b vaccine: reconstitution of lyophilised PRP-T vaccine with a pertussis-containing paediatric combination vaccine, or a change in the primary series immunisation schedule, may modify the serum anti-PRP antibody responses. Curr Med Res Opin 2001;17(3):197-209
   PubMed Web of Science ®Google Scholar
• Van Den Bergh MR, Spijkerman J, Francois N, et al. Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine and DTPa-IPV-Hib when coadministered as a 3-dose primary vaccination schedule in The Netherlands: a randomized controlled trial. Pediatr Infect Dis J 2011;30(9):e170-8
   PubMed Web of Science ®Google Scholar
• Gustafsson L, Hallander HO, Olin P, et al. A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine. N Engl J Med 1996;334(6):349-55
   PubMed Web of Science ®Google Scholar
• Kohberger RC, Jemiolo D, Noriega F. Prediction of pertussis vaccine efficacy using a correlates of protection model. Vaccine 2008;26(27-28):3516-21
   PubMed Web of Science ®Google Scholar
• Storsaeter J, Hallander HO, Gustafsson L, Olin P. Levels of anti-pertussis antibodies related to protection after household exposure to Bordetella pertussis. Vaccine 1998;16(20):1907-16
   PubMed Web of Science ®Google Scholar
• Mills E, Gold R, Thipphawong J, 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):576-85
   PubMed Web of Science ®Google Scholar
• Gold R, Barreto L, Ferro S, et al. Safety and immunogenicity of a fully liquid vaccine containing five-component pertussis-diphtheria-tetanus-inactivated poliomyelitis-Haemophilus influenzae type b conjugate vaccines administered at two, four, six and 18 months of age. Can J Infect Dis Med Microbiol 2007;18(4):241-8
   PubMed Web of Science ®Google Scholar
• Greenberg DP, Doemland M, Bettinger JA, et al. Epidemiology of pertussis and Haemophilus influenzae type b disease in Canada with exclusive use of a diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b pediatric combination vaccine and an adolescent-adult tetanus-diphtheria-acellular pertussis vaccine: implications for disease prevention in the United States. Pediatr Infect Dis J 2009;28(6):521-8
   PubMed Web of Science ®Google Scholar
• Plotkin SA. The pertussis problem. Clin Infect Dis 2014;58(6):830-3
   PubMed Web of Science ®Google Scholar
• Kitchin N, Southern J, Morris R, et al. Antibody persistence in UK pre-school children following primary series with an acellular pertussis-containing pentavalent vaccine given concomitantly with meningococcal group C conjugate vaccine, and response to a booster dose of an acellular pertussis-containing quadrivalent vaccine. Vaccine 2009;27(37):5096-102
   PubMed Web of Science ®Google Scholar
• Pediacel® [Product Monograph]. Sanofi Pasteur Limited. Toronto, Ontario, Canada: 2013
   Google Scholar
• David S, Vermeer-De Bondt PE, Van Der Maas NA. Reactogenicity of infant whole cell pertussis combination vaccine compared with acellular pertussis vaccines with or without simultaneous pneumococcal vaccine in the Netherlands. Vaccine 2008;26(46):5883-7
   PubMed Web of Science ®Google Scholar
• Kitchin NR, Southern J, Morris R, et al. Evaluation of a diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b vaccine given concurrently with meningococcal group C conjugate vaccine at 2, 3 and 4 months of age. Arch Dis Child 2007;92(1):11-16
   PubMed Web of Science ®Google Scholar
• Moss SJ, Fenton AC, Toomey J, et al. Immunogenicity of a heptavalent conjugate pneumococcal vaccine administered concurrently with a combination diphtheria, tetanus, five-component acellular pertussis, inactivated polio, and Haemophilus influenzae type B vaccine and a meningococcal group C conjugate vaccine at 2, 3, and 4 months of age. Clin Vaccine Immunol 2010;17(3):311-16
   PubMedGoogle Scholar
• Pace D, Snape M, Westcar S, et al. A new combination Haemophilus influenzae type B and Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine for primary immunization of infants. Pediatr Infect Dis J 2007;26(11):1057-9
   PubMed Web of Science ®Google Scholar
• Snape MD, Klinger CL, Daniels ED, et al. Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial. Pediatr Infect Dis J 2010;29(12):e80-90
   PubMed Web of Science ®Google Scholar
• Southern J, Borrow R, Andrews N, et al. Immunogenicity of a reduced schedule of meningococcal group C conjugate vaccine given concomitantly with the Prevenar and Pediacel vaccines in healthy infants in the United Kingdom. Clin Vaccine Immunol 2009;16(2):194-9
   PubMed Web of Science ®Google Scholar
• Slack MH, Cade S, Schapira D, et al. DT5aP-Hib-IPV and MCC vaccines: preterm infants’ response to accelerated immunisation. Arch Dis Child 2005;90(4):338-41
   PubMed Web of Science ®Google Scholar
• Ward JI, Greenberg DP, Anderson PW, et al. Variable quantitation of Haemophilus influenzae type b anticapsular antibody by radioantigen binding assay. J Clin Microbiol 1988;26(1):72-8
   PubMed Web of Science ®Google Scholar
• Grimprel E, Wysocki J, Boisnard F, et al. Immunogenicity and safety of fully liquid DTaP(5)-IPV-Hib compared with DTaP(3)-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: A phase III, single-blind, randomised, controlled, multicentre study. Vaccine 2011;29(43):7370-8
   PubMed Web of Science ®Google Scholar
• Study to compare Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar® in infants and toddlers. Available from: http://clinicaltrials.gov/ct2/show/NCT00343421
   Google Scholar
• Kitchin N, Southern J, Morris R, et al. A randomised controlled study of the reactogenicity of an acellular pertussis-containing pentavalent infant vaccine compared to a quadrivalent whole cell pertussis-containing vaccine and oral poliomyelitis vaccine, when given concurrently with meningococcal group C conjugate vaccine to healthy UK infants at 2, 3 and 4 months of age. Vaccine 2006;24(18):3964-70
   PubMed Web of Science ®Google Scholar
• Primary & booster immunogenicity study of GSK biologicals’ hib-menc versus a licensed men-c vaccine. Available from: http://clinicaltrials.gov/show/NCT00258700
   Google Scholar
• Study to evaluate a 13-valent pneumococcal conjugate vaccine in infants. Available from: http://clinicaltrials.gov/ct2/show/NCT00384059
   Google Scholar
• Response of United Kingdom (UK) infants to a reduced primary schedule with meningococcal c and pneumococcal conjugate vaccines (sched1). Available from: www.clinicaltrials.gov/ct2/show/NCT00197808
   Google Scholar
• Co-administration of pneumococcal conjugate vaccine with DTPA-IPV-HIB versus co-administration with dtpa-hbv-ipv/hib. Available from: http://clinicaltrials.gov/show/NCT00652951
   Google Scholar
• Lin TY, Wang YH, Chang LY, et al. A fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b conjugate vaccine: immunogenicity and safety of primary vaccination in Taiwanese infants. Int J Infect Dis 2007;11(2):129-36
   PubMed Web of Science ®Google Scholar
• Lin TY, Wang YH, Huang YC, et al. One-year post-primary antibody persistence and booster immune response to a fully liquid five-component acellular pertussis, diphtheria, tetanus, inactivated poliomyelitis, Haemophilus influenzae type b conjugate vaccine. Int J Infect Dis 2007;11(6):488-95
   PubMed Web of Science ®Google Scholar
• Castaneda JL, Gonzalez N, Chavez R, et al. Enhanced inactivated poliovaccine (IPV) in a fully liquid pentavalent DTaP-IPV-PRP-T combination: immunogenicity and safety in Mexican infants. Poster 346 2004
   Google Scholar
• Castaneda JL, Gonzalez N, Lavigne P, Ortiz E. Immunogenicity and safety of a fully liquid DTaP-IPV-Hib vaccine with full primary IPV or sequential IPV-OPV in Mexican infants. Poster 18.010 2004
   Google Scholar
• Capeding MR, Unalivia L, Victoria MV, et al. Immunogenicity and safety of a fully liquid DTaP-IPV-HiB vaccine in infants at 6, 10, and 14 weeks of age (EPI schedule). Poster 59 2002
   Google Scholar
• Langley JM, Halperin SA, Rubin E, et al. Safety and immunogenicity of 2 mixed primary infant immunization schedules of pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, and Haemophilus influenzae Type B vaccines at 2, 4, and 6 months of age: a randomized controlled trial. Pediatr Infect Dis J 2012;31(2):189-92
   PubMed Web of Science ®Google Scholar
• Interchangeability of Infanrix™ IPV/Hib and Pediacel® at 2,4 & 6 months of age. Available from: http://clinicaltrials.gov/ct2/show/NCT00990080
   Google Scholar
• Berner R, Boisnard F, Thomas S, et al. Safety and immunogenicity of fully liquid DTaP(5)-IPV-Hib pediatric combination vaccine (Pediacel®) compared to DTaP(3)-HBV-IPV/Hib (Infanrix® Hexa) when coadministered with heptavalent pneumococcal conjugate vaccine (PCV7) as a booster at 11-18 months of age: a phase III, modified double-blind, randomized, controlled, multicenter study. Vaccine 2012;30(35):5270-7
   PubMed Web of Science ®Google Scholar
• Study to compare booster vaccination with Pediacel® to Infanrix® hexa when both are co-administered with Prevenar®. Available from: http://clinicaltrials.gov/ct2/show/NCT00355654
   Google Scholar
• Vesikari T, Silfverdal SA, Boisnard F, et al. Randomized, controlled, multicenter study of the immunogenicity and safety of a fully liquid combination diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and haemophilus influenzae type b (Hib) vaccine compared with a DTaP3-IPV/Hib vaccine administered at 3, 5, and 12 months of age. Clin Vaccine Immunol 2013;20(10):1647-53
   PubMedGoogle Scholar
• Comparison of safety and immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) given in a 3 dose schedule in infants. Available from: www.clinicaltrials.gov/ct2/show/NCT00287092
   Google Scholar
• Andrews N, Stowe J, Wise L, Miller E. Post-licensure comparison of the safety profile of diphtheria/tetanus/whole cell pertussis/Haemophilus influenza type b vaccine and a 5-in-1 diphtheria/tetanus/acellular pertussis/Haemophilus influenza type b/polio vaccine in the United Kingdom. Vaccine 2010;28(44):7215-20
   PubMed Web of Science ®Google Scholar