Abstract
-
▲ The combination vaccine diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccine (DTaP-IPV/Hib), which has been exclusively used in Canada for more than 10 years, is the first DTaP-based vaccine approved in the US that includes both poliovirus and Haemophilus influenzae type b (Hib) antigens.
-
▲ In clinical trials, the combined DTaP-IPV/Hib vaccine induced high immunogenecity against all of the vaccine antigens, including Hib.
-
▲ Administration of the DTaP-IPV/Hib vaccine as a four-dose series in infants provided high levels of seroprotection against diphtheria and tetanus toxoids, poliovirus types 1, 2, and 3, and Hib polyribosyl-ribitol-phosphate capsular polysaccharide conjugated to tetanus toxoid (PRP-T). Immune responses produced after doses 3 and 4 of DTaP-IPV/Hib vaccine were noninferior to those seen with separately administered DTaP, inactivated poliovirus, and Hib vaccines, apart from those against PRP-T in one study.
-
▲ Seroconversion rates for the five pertussis components in DTaP-IPV/Hib vaccine were noninferior to those seen in infants receiving the separately administered vaccines. A serology bridging study showed the noninferiority of four doses of DTaP-IPV/Hib vaccine to three doses of a DTaP vaccine in terms of seroconversion rates for filamentous hemagglutinin and fimbriae 2 and 3, but not pertactin.
-
▲ There were no clinically relevant changes in the immunogenicity of DTaP-IPV/Hib when coadministered with pneumococcal-7-valent-CRM197 vaccine or measles, mumps, and rubella vaccine and varicella zoster vaccine at 15 months.
-
▲ The tolerability profile of DTaP-IPV/Hib vaccine was generally similar to that of separately administered DTaP, IPV, and Hib vaccines.
Similar content being viewed by others
Notes
The use of trade names is for product identification purposes only and does not imply endorsement.
References
Centers for Disease Control and Prevention. Vaccine timeline [online]. Available from URL: http://www.cdc.gov/vaccines/pubs/vacc-timeline.htm#50years [Accessed 2008 Sep 4]
World Health Organization. 10 facts on immunization [online]. Available from URL: http://www.who.int/features/factfiles/immunization/en/index.html [Accessed 2008 Sep 4]
United Nations Children’s Fund. Immunization summary: the 2007 edition [online]. Available from URL: http://www.unicef.org/publications/files/Immunization_Summary_2007.pdf [Accessed 2008 Sep 4]
Sanofi Pasteur. US FDA licenses Sanofi Pasteur’s new pediatric combination vaccine, Pentacel® [media release]. 2008 Jun 23
Centers for Disease Control and Prevention. Combination vaccines for childhood immunization: recommendations of the Advisory Committee on lmmunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP). MMWR 1999; 48(No. RR-5)
Centers for Disease Control and Prevention. Recommended immunization schedule for persons aged 0–6 years [online]. Available from URL: http://www.cdc.gov/vaccines/recs/schedules/downloads/child/2008/08_0-6yrs_schedule_bw_pr.pdf [Accessed 2008 Sep 4]
Public Health Agency of Canada. Immunization schedules [online]. Available from URL: http://www.phac-aspc.gc.ca/im/is-cv/index-eng.php#a [Accessed 2008 Sep 4]
Black S, Greenberg DP. A combined diphtheria, tetanus, five-component acellular pertussis, poliovirus and Haemophilus influenzae type b vaccine. Future Drugs 2005; 4(6): 793–805
Sanofi Pasteur Inc. Diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccine (Pentacel): US product information [online]. Available from URL: http://www.fda.gov/cber/label/pentacelLB.pdf [Accessed 2008 Oct 17]
Eskola J, Olander RM, Hovi T, et al. Randomised trial of the effect of coadministration with acellular pertussis DTP vaccine on immunogenicity of Haemophilus influenzae type b conjugate vaccine. Lancet 1996 Dec 21; 348(9043): 1688–92
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 Apr; 16(6): 576–85
Lee CY, Thipphawong J, Huang LM, et al. An evaluation of the safety and immunogenicity of a five-component acellular pertussis, diphtheria, and tetanus toxoid vaccine (DTaP) when combined with a Haemophilus influenzae type b-tetanus toxoid conjugate vaccine (PRP-T) in Taiwanese infants. Pediatrics 1999 Jan; 103(1): 25–30
Chatterjee A, Jordanov E, Klein N, et al. Comparative immunogenicity of different 5-component acellular pertussis vaccine formulations in infants [abstract no. 4464.12]. Pediatric Acedemic Societies’ and Asian Society for Pediatric Research Joint Meeting; 2008 May 2–6; Honolulu (HI)
Scheifele DW, Bettinger JA, Halperin SA, et al. Ongoing control of haemophilus influenzae type b infections in Canadian children, 2004–2007. Pediatr lnfect Dis J 2008 Aug; 27(8): 1–2
Greenberg DP, Doemland ML, Lavigne P, et al. Impact of Pentacel (DTaP-IPV//PRP-T) on the epidemiology of invasive Hib disease and pertussis in Canada. The 5th Pediatric Infectious Disease Society Conference; 2005 Oct 10–11; Napa (CA)
Food and Drug Administration. Pentacel: immunogenicity review [online]. Available from URL: http://www.fda.gov/cber/products/pentacel/pentacel061908mem.pdf [Accessed 2008 Aug 8]
Food and Drug Administration. Pentacel: clinical safety review [online]. Available from URL: http://www.fda.gov/cber/products/pentacel/pentacel061308mem.pdf [Accessed 2008 Aug 8]
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 Feb 8; 334(6): 349–55
Noriega F, Tomovici A, Jemiolo D, et al. Safety and immunogenicity comparison of a fourth dose of DTaP-IPV//PRP-T (Pentacel™) to the separate administration of DAPTACEL® and ActHIB® [abstract no. 985]. 43rd Annual Meeting of the lnfectious Diseases Society of America; 2005 Oct 6–9; San Francisco (CA)
Edwards KM, Tsang PH, Wang L, et al. Safety and immunogenicity of DTaP-IPV//PRP-T (Pentacel™) coadministered with pneumococcal conjugate vaccine (Prevnar®) at 2, 4, and 6 months of age [abstract no. 984]. 43rd Annual Meeting of the Infectious Diseases Society of America; 2005 Oct 6–9; San Francisco (CA)
Noriega F, Tsang P, Jemiolo D, et al. Immunogenicity of a four-dose series of DTaP-IPV//PRP-T (Pentacel®) [abstract no. 9]. The 5th Pediatric Infectious Disease Conference; 2005 Oct 10–11; Napa (CA)
Noriega F, Greenberg DP, Tsang PH, et al. Effect of pneumococcal conjugate vaccine on antibody responses to concomitantly administered Pentacel™ (DTaP-IPV//PRP-T) or licensed equivalent vaccines [abstract no. 981]. 43rd Annual Meeting of the Infectious Diseases Society of America; 2005 Oct 6–9; San Francisco (CA)
Scheifele DW, Halperin SA, Rubin E, et al. Safety and immunogenicity of a pentavalent combination vaccine (diphtheria, tetanus, acellular pertussis, polio, and Haemophilus influenzae type b conjugate) when administered as a fourth dose at 15 to 18 months of age. Hum Vaccin 2005 Sep 31; 1(5): 180–6
Sanofi Pasteur Inc.. DAPTACEL: US prescribing information [online]. Available from URL: http://www.fda.gov/cber/products/daptacel.htm [Accessed 2008 Oct 17]
Food and Drug Administration. Review memo (4/7/2006) [online]. Available from URL: http://www.fda.gov/cber/products/pentacel/pentacel040706mem.pdf [Accessed 2008 Oct 24]
Acknowledgments and Disclosures
The manuscript was reviewed by: R. Dagan, Pediatric Infectious Disease Unit, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel; S. Black, Cincinnati Children’s Hospital, Center for Global Child Health, Cincinnati, Ohio, USA.
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was also offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Dhillon, S., Keam, S.J. DTaP-IPV/Hib Vaccine (Pentacel®). Pediatr-Drugs 10, 405–416 (2008). https://doi.org/10.2165/0148581-200810060-00008
Published:
Issue Date:
DOI: https://doi.org/10.2165/0148581-200810060-00008