Abstract
Infanrix hexa™, a diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis, and Haemophilus influenzae type b (Hib) conjugate vaccine, is indicated for primary and booster vaccination of infants. Available clinical data from more than a decade of experience with the vaccine indicate that primary and booster vaccination with Infanrix hexa™ is a safe and useful option for providing protection against the common childhood diseases of diphtheria, tetanus, poliomyelitis, pertussis, hepatitis B, and disease caused by Hib.
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References
World Health Organization. Table 2: summary of WHO position papers. Recommended routine immunizations for children [online]. Available from: http://www.who.int/immunization/policy/Immunization_routine_table2.pdf [Accessed 2012 Jun 14]
Global immunization vision and strategy: 2006–2015. Geneva: World Health Organization, 2005 Oct.
Infanrix hexa: summary of product characteristics. London: European Medicines Agency, 2011 Sep 14.
Kalies H, Grote V, Verstraeten T, et al. The use of combination vaccines has improved timeliness of vaccination in children. Pediatr Infect Dis J 2006 Jun; 25 (6): 507–12.
Zepp F, Knuf M, Heininger U, et al. Safety, reactogenicity and immunogenicity of a combined hexavalent tetanus, diphtheria, acellular pertussis, hepatitis B, inactivated poliovirus vaccine and Haemophilus influenzae type b conjugate vaccine, for primary immunization of infants. Vaccine 2004 Jun 2; 22 (17–18): 2226–33.
Schmitt HJ, Knuf M, Ortiz E, et al. Primary vaccination of infants with diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio virus and Haemophilus influenzae type b vaccines given as either separate or mixed injections. J Pediatr 2000 Sep; 137 (3): 304–12.
Arístegui J, Dal-Ré R, Díez-Delgado J, 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 Sep 8; 21 (25–26): 3593–600.
Avdicová M, Prikazsky V, Hudecková H, et al. Immunogenicity and reactogenicity of a novel hexavalent DTPa-HBV-IPV/Hib vaccine compared to separate concomitant injections of DTPa-IPV/Hib and HBV vaccines, when administered according to a 3, 5 and 11 month vaccination schedule. Eur J Pediatr 2002 Nov; 161 (11): 581–7.
Gabutti G, Zepp F, Schuerman L, et al. Evaluation of the immunogenicity and reactogenicity of a DTPa-HBV-IPV combination vaccine co-administered with a Hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age. Scand J Infect Dis 2004; 36 (8): 585–92.
Heininger U, Sänger R, Jacquet JM, et al. Booster immunization with a hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine and Haemophilus influenzae type b conjugate combination vaccine in the second year of life: safety, immunogenicity and persistence of antibody responses. Vaccine 2007 Jan 22; 25 (6): 1055–63.
Tichmann I, Grunert D, Habash S, et al. Persistence of antibodies in children primed with two different hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type B vaccines and evaluation of booster vaccination. Hum Vaccin 2006 Nov 31; 2 (6): 249–54.
Van Der Meeren O, Kuriyakose S, Kolhe D, et al. Immunogenicity of Infanrix™ hexa administered at 3, 5 and 11 months of age. Vaccine 2012 Apr 5; 30 (17): 2710–4.
Pichichero ME, Blatter MM, Reisinger KS, et al. Impact of a birth dose of hepatitis B vaccine on the reactogenicity and immunogenicity of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus -Haemophilus influenzae type b combination vaccination. Pediatr Infect Dis J 2002 Sep; 21 (9): 854–9.
Lim FS, Han HH, Jacquet JM, et al. Primary vaccination of infants against hepatitis B can be completed using a combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis -Haemophilus influenzae type B vaccine. Ann Acad Med Singapore 2007 Oct; 36 (10): 801–6.
Omenaca F, Garcia-Sicilia J, Boceta R, et al. Antibody persistence and booster vaccination during the second and fifth years of life in a cohort of children who were born prematurely. Pediatr Infect Dis J 2007 Sep; 26 (9): 824–9.
Omeñaca F, Garcia-Sicilia J, García-Corbeira P, et al. Antipolyribosyl ribitol phosphate response of premature infants to primary and booster vaccination with a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio virus/Haemophilus influenzae type b vaccine. Pediatrics 2007 Jan; 119 (1): e179–85.
Omeñaca F, Garcia-Sicilia J, García-Corbeira P, et al. Response of preterm newborns to immunization with a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio and Haemophilus influenzae type b vaccine: first experiences and solutions to a serious and sensitive issue. Pediatrics 2005 Dec; 116 (6): 1292–8.
Vazquez L, Garcia F, Ruttimann R, et al. Immunogenicity and reactogenicity of DTPa-HBV-IPV/Hib vaccine as primary and booster vaccination in low-birth-weight premature infants. Acta Paediatr 2008 Sep; 97 (9): 1243–9.
World Health Organization. WHO position paper on Haemophilus influenzae type b conjugate vaccines. Wkly Epidemiol Rec 2006; 81 (47): 445–52.
Zinke M, Disselhoff J, Gartner B, et al. Immunological persistence in 4–6 and 7–9 year olds previously vaccinated in infancy with hexavalent DTPa-HBV-IPV/Hib. Hum Vaccin 2010 Feb 18; 6 (2): 189–93.
Gustafsson L, Hessel L, Storsaeter J, et al. Long-term follow-up of Swedish children vaccinated with acellular pertussis vaccines at 3, 5, and 12 months of age indicates the need for a booster dose at 5 to 7 years of age. Pediatrics 2006 Sep; 118 (3): 978–84.
Avdicova M, Crasta P, Hardt K, et al. Lasting immune memory against hepatitis B 10 years after the 2+1 primary vaccination schedule with DTPa-HBV-IPV/Hib or DTPa-IPV/Hib+HBV [abstract no. A-435-0028–00311 plus poster]. 30th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2012 May 8–12; Thessaloniki.
Steiner M, Ramakrishnan G, Gartner B, et al. Lasting immune memory against hepatitis B in children after primary immunization with 4 doses of DTPa-HBV-IPV/Hib in the first and 2nd year of life. BMC Infect Dis 2010; 10: 9.
Zinke M, Kappes R, Kindler K, et al. Immune memory to hepatitis B virus in 4–9-year old children vaccinated in infancy with four doses of hexavalent DTPa-HBV-IPV/Hib vaccine. Hum Vaccin 2009 Sep; 5 (9): 592–8.
Zepp F, Schmitt HJ, Cleerbout J, et al. Review of 8 years of experience with Infanrix hexa (DTPa-HBV-IPV/Hib hexavalent vaccine). Expert Rev Vaccines 2009 Jun; 8 (6): 663–78.
Nolan T, Altmann A, Skeljo M, et al. Antibody persistence, PRP-specific immune memory, and booster responses in infants immunised with a combination DTPa-HBV-IPV/Hib vaccine. Vaccine 2004 Nov 15; 23 (1): 14–20.
Pichichero ME. Booster vaccinations: can immunologic memory outpace disease pathogenesis? Pediatrics 2009; 124 (6): 1633–41.
Tichmann-Schumann I, Soemantri P, Behre U, et al. Immunogenicity and reactogenicity of four doses of diphtheria-tetanus-three-component acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b vaccine coadministered with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J 2005 Jan; 24 (1): 70–7.
Knuf M, Habermehl P, Cimino C, et al. Immunogenicity, reactogenicity and safety of a 7-valent pneumococcal conjugate vaccine (PCV7) concurrently administered with a DTPa-HBV-IPV/Hib combination vaccine in healthy infants. Vaccine 2006 May 29; 24 (22): 4727–36.
Whelan J, Hahné S, Berbers G, et al. Immunogenicity of a hexavalent vaccine co-administered with 7-valent pneumococcal conjugate vaccine: findings from the National Immunisation Programme in the Netherlands. Hum Vaccin Immunother 2012 Jun 1; 8 (6)
Knuf M, Szenborn L, Moro M, et al. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J 2009 Apr; 28 Suppl. 4: S97–108.
van den Bergh MR, Spijkerman J, Swinnen K, et al. Immunogenicity of a booster dose of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) in Dutch children [abstract no. 317]. 8th International Symposium on Pneumococci and Pneumococcal Diseases; 2012 Mar 11–15; Iguaçu Falls.
Gimenez-Sanchez F, Kieninger DM, Kueper K, et al. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine. Vaccine 2011 Aug 11; 29 (35): 6042–8.
Tregnaghi MW, Sáez-Llorens X, Abate H, et al. Immungenicity profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) in Latin American children enrolled in COMPAS [abstract]. 7th World Congress of the World Society for Pediatric Infectious Diseases (WSPID); 2011 Nov 16–19; Melbourne.
Tejedor JC, Omeñaca F, García-Sicilia J, et al. Immunogenicity and reactogenicity of a three-dose primary vaccination course with a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio -Haemophilus influenzae type b vaccine coadministered with a meningococcal C conjugate vaccine. Pediatr Infect Dis J 2004 Dec; 23 (12): 1109–15.
Tejedor JC, Omeñaca F, García-Sicilia J, et al. Antibody persistence after primary vaccination with a hexavalent DTPa-HBV-IPV/HiB vaccine coadministered with a meningococcal C-CRM197 vaccine and response to a DTPa-IPV/HiB booster at 18 months of age. Pediatr Infect Dis J 2006 Oct; 25 (10): 943–5.
Tejedor JC, Moro M, Ruiz-Contreras J, 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 Aug; 25 (8): 713–20.
Knuf M, Pantazi-Chatzikonstantinou A, Pfletschinger U, et al. An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix™ hexa is immunogenic, with an acceptable safety profile in 12–23-month-old children. Vaccine 2011 Jun 6; 29 (25): 4264–73.
Zepp F, Behre U, Kindler K, et al. Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine co-administered with a booster dose of a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine in healthy children aged 12–23 months. Eur J Pediatr 2007 Aug; 166 (8): 857–64.
Vesikari T, Karvonen A, Prymula R, et al. Immunogenicity and safety of the human rotavirus vaccine Rotarix co-administered with routine infant vaccines following the vaccination schedules in Europe. Vaccine 2010 Jul 19; 28 (32) 5272–9.
Kalies H, Grote V, Siedler A, et al. Effectiveness of hexavalent vaccines against invasive Haemophilus influenzae type b disease: Germany’s experience after 5 years of licensure. Vaccine 2008 May 12; 26 (20): 2545–52.
Schmitt HJ, von König CH, Neiss A, et al. Efficacy of acellular pertussis vaccine in early childhood after household exposure. JAMA 1996 Jan 3; 275 (1): 37–41.
Greco D, Salmaso S, Mastrantonio P, et al. A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis. N Engl J Med 1996 Feb 8; 334 (6): 341–8.
Saenger R, Maechler G, Potreck M, et al. Booster vaccination with hexavalent DTPa-HBV-IPV/Hib vaccine in the second year of life is as safe as concomitant DTPa-IPV/Hib+HBV administered separately. Vaccine 2005 Jan 19; 23 (9): 1135–43.
von Kries R, Toschke AM, Strassburger K, et al. Sudden and unexpected deaths after the administration of hexavalent vaccines (diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b): is there a signal? Eur J Pediatr 2005 Feb; 164 (2): 61–9.
von Kries R. Commenton B, Zinka et al. Unexplained cases of sudden infant death shortly after hexavalent vaccination [letter]. Vaccine 2006 Jul 26; 24 (31–32): 5783–4; author reply 5785–6.
Dhillon S. DTPa-HBV-IPV/Hib Vaccine (Infanrix hexa™): a review of its use as primary and booster vaccination. Drugs 2010; 70 (8): 1021–58.
Acknowledgments and Disclosures
This article was updated from Drugs 2010; 70 (8): 1021-58,[47] and was reviewed by G. Gabutti, Department of Clinical and Experimental Medicine, University of Ferrara, Italy; M.E. Pichichero, Research Institute, Rochester General Hospital, Rochester, NY, USA; R. Prymula, University Hospital, Hrádec Kralové, Czech Republic.
The preparation of these articles was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the articles. Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit.
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Lyseng-Williamson, K.A., Dhillon, S. DTPa-HBV-IPV/Hib Vaccine (Infanrix hexa™): A Guide to Its Use in Infants. Pediatr Drugs 14, 337–343 (2012). https://doi.org/10.1007/BF03262239
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DOI: https://doi.org/10.1007/BF03262239