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Review

Infant vaccine co-administration: review of 18 years of experience with GSK’s hexavalent vaccine co-administered with routine childhood vaccines

Pages 419-443 | Received 06 Nov 2019, Accepted 17 Apr 2020, Published online: 18 May 2020

References

  • World Health Organization. WHO vaccine-preventable diseases: monitoring system, 2019 global summary. Immunization schedule by disease covered by antigens within age range selection centre; [cited 2020 Jan 29]. Available from: https://apps.who.int/immunization_monitoring/globalsummary/diseases
  • General Recommendations on Immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2011;60(2):1–64.
  • 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;25(6):507–512.
  • Happe LE, Lunacsek OE, Kruzikas DT, et al. Impact of a pentavalent combination vaccine on immunization timeliness in a state Medicaid population. Pediatr Infect Dis J. 2009;28(2):98–101.
  • Marshall GS, Happe LE, Lunacsek OE, et al. Use of combination vaccines is associated with improved coverage rates. Pediatr Infect Dis J. 2007;26(6):496–500.
  • Maman K, Zöllner Y, Greco D, et al. The value of childhood combination vaccines: from beliefs to evidence. Hu Vacc Immunother. 2015;11(9):2132–2141.
  • Van Hoof J. Manufacturing issues related to combining different antigens: an industry perspective. Clin Infect Dis. 2001;33(Suppl 4):S346–350.
  • Dagan R, Poolman J, Siegrist CA. Glycoconjugate vaccines and immune interference: A review. Vaccine. 2010;28(34):5513–5523.
  • 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;28(4 Suppl):S97–S108.
  • Dagan R, Poolman JT, Zepp F. Combination vaccines containing DTPa-Hib: impact of IPV and coadministration of CRM197 conjugates. Expert Rev Vaccines. 2008;7(1):97–115.
  • Findlow H, Borrow R. Interactions of conjugate vaccines and co-administered vaccines. Hum Vaccin Immunother. 2016;12(1):226–230.
  • Knuf M, Kowalzik F, Kieninger D. Comparative effects of carrier proteins on vaccine-induced immune response. Vaccine. 2011;29(31):4881–4890.
  • European Medicines Agency. Infanrix hexa product information. [cited 2019 Sept 6]. Available from: https://www.ema.europa.eu/en/documents/product-information/infanrix-hexa-epar-product-information_en.pdf
  • European Medicines Agency. Hexaxim product information. [cited 2020 Jan 29]. Available from: https://www.ema.europa.eu/documents/medicine-outside-eu/hexaxim-h-w-2495-p46-021-assessment-report_en.pdf
  • European Medicines Agency. Hexacima product information. [cited 2020 Jan 29]. Available from: https://www.ema.europa.eu/documents/product-information/hexacima-epar-product-information_en.pdf
  • European Medicines Agency. Hexyon product information. [cited 2020 Jan 29]. Available from: https://www.ema.europa.eu/documents/product-information/hexyon-epar-product-information_en.pdf
  • European Medicines Agency. Vaxelis product information. [cited 2020 Jan 29]. Available from: https://www.ema.europa.eu/documents/product-information/vaxelis-epar-product-information_en.pdf
  • Food and Drug Administration. Vaxelis package insert. [cited 2020 Jan 29]. Available from: https://www.fda.gov/media/119465/download
  • Van Der Meeren O, Kuriyakose S, Kolhe D, et al. Immunogenicity of InfanrixTM hexa administered at 3, 5 and 11 months of age. Vaccine. 2012;30(17):2710–2714.
  • Omenaca F, Vazquez L, Garcia-Corbeira P, et al. Immunization of preterm infants with GSK’s hexavalent combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine: A review of safety and immunogenicity. Vaccine. 2018;36(7):986–996.
  • Zepp F, Schmitt H-J, Cleerbout J, et al. Review of 8 years of experience with Infanrix hexa (DTPa-HBV-IPV/Hib hexavalent vaccine). Expert Rev Vaccines. 2009;8(6):663–678.
  • Dolhain J, Janssens W, Mesaros N, et al. Hexavalent vaccines: increasing options for policy-makers and providers. A review of the data supporting interchangeability (substitution with vaccines containing fewer antigens) and mixed schedules from the same manufacturer. Expert Rev Vaccines. 2018;17(6):513–524.
  • European Centre for Disease Prevention and Control. Vaccination schedules for individual European countries and specific age groups. [cited 2020 Jan 29]. Available from: https://www.ecdc.europa.eu/en/immunisation-vaccines/EU-vaccination-schedules
  • World Health Organization. Summary of WHO position papers - recommended routine immunizations for children. [cited 2020 Jan 29]. Available from: https://www.who.int/immunization/policy/Immunization_routine_table2.pdf
  • Schmitt HJ, Steul KS, Borkowski A, et al. Two versus three doses of a meningococcal C conjugate vaccine concomitantly administered with a hexavalent DTaP-IPV-HBV/Hib vaccine in healthy infants. Vaccine. 2008;26(18):2242–2252.
  • 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;25(8):713–720.
  • Szenborn L, Czajka H, Brzostek J, et al. A randomized, controlled trial to assess the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, hib and meningococcal serogroup C combination vaccine administered at 2, 3, 4 and 12-18 months of age. Pediatr Infect Dis J. 2013;32(7):777–785.
  • Thollot F, Scheifele D, Pankow-Culot H, et al. A randomized study to evaluate the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, haemophilus influenzae b, and meningococcal serogroup C combination vaccine administered to infants at 2, 4 and 12 months of age. Pediatr Infect Dis J. 2014;33(12):1246–1254.
  • Habermehl P, Leroux-Roels G, Sänger R, et al. Combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2, 3, 4 months schedule with a fourth dose at 12-18 months of age. Hum Vaccines. 2010;6(8):640–651.
  • Merino Arribas JM, Carmona Martinez A, Horn M, et al. Safety and Immunogenicity of the quadrivalent meningococcal serogroups A, C, W and Y tetanus toxoid conjugate vaccine coadministered with routine childhood vaccines in European infants: an open, randomized trial. Pediatr Infect Dis J. 2017;36(4):e98–e107.
  • Vesikari T, Forstén A, Desole MG, et al. A combined haemophilus influenzae type b-neisseria meningitidis serogroup C-Tetanus Toxoid conjugate vaccine (Hib-MenC-TT) is Immunogenic and well-tolerated when co-administered with DTPa-HBV-IPV at 3, 5, and 11 months of age: results of an open, randomized, controlled study. Pediatr Infect Dis J. 2013;32:521–529.
  • Esposito S, Prymula R, Zuccotti GV, et al. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II). Hu Vacc Immunother. 2014;10(7):2005–2014.
  • Lagos RE, Munoz AE, Levine MM, et al. Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children. Hum Vaccin. 2011;7(5):511–522.
  • van den Bergh MR, Spijkerman J, Francois N, et al. Immunogenicity, safety and reactogenicity of a booster dose of the 10-valent pneumococcal nontypeable H. influenzae protein D conjugate vaccine coadministered with DTPa-IPV-Hib in Dutch children: a randomized controlled trial. Pediatr Infect Dis J. 2016;35(7):e206–219.
  • Lin TY, Lu CY, Chang LY, et al. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Taiwan. J Formos Med Assoc. 2012;111(9):495–503.
  • Wijmenga-Monsuur AJ, van Westen E, Knol MJ, et al. Direct comparison of immunogenicity induced by 10- or 13-valent pneumococcal conjugate vaccine around the 11-month booster in Dutch infants. PLoS One. 2015;10(12):e0144739.
  • Ruiz-Palacios GM, Guerrero ML, Hernandez-Delgado L, et al. Immunogenicity, reactogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Mexican infants. Hum Vaccin. 2011;7(11):1137–1145.
  • Huu TN, Toan NT, Tuan HM, et al. Safety and reactogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Vietnamese infants: a randomised, controlled trial. BMC Infect Dis. 2013;13:95.
  • Prymula R, Szenborn L, Silfverdal SA, et al. Safety, reactogenicity and immunogenicity of two investigational pneumococcal protein-based vaccines: results from a randomized phase II study in infants. Vaccine. 2017;35(35Pt B):4603–4611.
  • Esposito S, Tansey S, Thompson A, et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine compared to those of a 7-valent pneumococcal conjugate vaccine given as a three-dose series with routine vaccines in healthy infants and toddlers. Clin vaccin immunol. 2010;17(6):1017–1026.
  • Martinón-Torres F, Gimenez-Sanchez F, Gurtman A, et al. 13-valent pneumococcal conjugate vaccine given with meningococcal C-tetanus toxoid conjugate and other routine pediatric vaccinations: immunogenicity and safety. Pediatr Infect Dis J. 2012;31(4):392–399.
  • Kieninger DM, Kueper K, Steul K, et al. Safety, tolerability, and immunologic noninferiority of a 13-valent pneumococcal conjugate vaccine compared to a 7-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in Germany. Vaccine. 2010;28(25):4192–4203.
  • 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;29(35):6042–6048.
  • Vesikari T, Becker T, Vertruyen AF, et al. A phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at two, three, four and twelve months. Pediatr Infect Dis J. 2017;36(2):209–215.
  • 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;23(12):1109–1115.
  • Tejedor J-C, 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;25(10):943–945.
  • Merino Arribas JM, Carmona Martinez A, Horn M, et al. Immunogenicity and reactogenicity of DTPa-HBV-IPV/Hib and PHiD-CV when coadministered with MenACWY-TT in infants: results of an open, randomized trial. Pediatr Infect Dis J. 2018;37(7):704–714.
  • 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;29(25):4264–4273.
  • Gossger N, Snape MD, Yu L-M, et al. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA. 2012;307(6):573–582.
  • Findlow J, Borrow R, Snape MD, et al. Multicenter, open-label, randomized phase ii controlled trial of an investigational recombinant meningococcal serogroup B vaccine with and without outer membrane vesicles, administered in infancy. Clin Infect Dis. 2010;51(10):1127–1137.
  • Snape MD, Dawson T, Oster P, et al. Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial. Pediatr Infect Dis J. 2010;29(11):e71–79.
  • Vesikari T, Esposito S, Prymula R, et al. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013;381(9869):825–835.
  • Leder K, Tong S, Weld L, et al. Illness in travelers visiting friends and relatives: a review of the GeoSentinel surveillance network. Clin Infect Dis. 2006;43(9):1185–1193.
  • Prymula R, Esposito S, Zuccotti GV, et al. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I). Hu Vacc Immunother. 2014;10(7):1993–2004.
  • van den Bergh MR, Spijkerman J, François 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):e170–178.
  • Tse A, Tseng HF, Greene SK, et al. Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010-2011. Vaccine. 2012;30(11):2024–2031.
  • Tseng HF, Sy LS, Liu IL, et al. Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children. Vaccine. 2013;31(22):2578–2583.
  • Duffy J, Weintraub E, Hambidge SJ, et al. Febrile seizure risk after vaccination in children 6 to 23 months. Pediatrics. 2016;138:1.
  • Tregnaghi MW, Sáez-Llorens X, López P, et al. Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial. PLoS Med. 2014;11(6):e1001657–e1001657.
  • Chevallier B, Vesikari T, Brzostek J, et al. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 2009;28(4 Suppl):S109–118.
  • Wysocki J, Tejedor JC, Grunert D, et al. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with different neisseria meningitidis serogroup C conjugate vaccines. Pediatr Infect Dis J. 2009;28(4 Suppl):S77–88.
  • Wysocki J, Center KJ, Brzostek J et al. A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations. Vaccine. 2017;35(15):1926–1935.
  • Prymula R, Siegrist C-A, Chlibek R, et al. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet. 2009;374(9698):1339–1350.
  • Falup-Pecurariu O, Man SC, Neamtu ML, et al. Effects of prophylactic ibuprofen and paracetamol administration on the immunogenicity and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine (PHiD-CV) co-administered with DTPa-combined vaccines in children: an open-label, randomized, controlled, non-inferiority trial. Hum Vaccin Immunother. 2017;13(3):649–660.
  • Leung AK, Robson WL. Febrile seizures. J Pediatr Health Care. 2007;21(4):250–255.
  • Silfverdal SA, Icardi G, Vesikari T, et al. A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months. Vaccine. 2016;34(33):3810–3816.
  • 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;28(32):5272–5279.
  • Ciarlet M, He S, Lai S, et al. Concomitant use of the 3-dose oral pentavalent rotavirus vaccine with a 3-dose primary vaccination course of a diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type b vaccine: immunogenicity and reactogenicity. Pediatr Infect Dis J. 2009;28(3):177–181.
  • 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;166(8):857–864.
  • Deichmann KA, Ferrera G, Tran C, et al. Immunogenicity and safety of a combined measles, mumps, rubella and varicella live vaccine (ProQuad (R)) administered concomitantly with a booster dose of a hexavalent vaccine in 12-23-month-old infants. Vaccine. 2015;33(20):2379–2386.
  • Vesikari T, Karvonen A, Lindblad N, et al. Safety and immunogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine coadministered with measles-mumps-rubella-varicella vaccine in children aged 12 to 16 months. Pediatr Infect Dis J. 2010;29(6):e47–56.
  • Orsi A, Azzari C, Bozzola E, et al. Hexavalent vaccines: characteristics of available products and practical considerations from a panel of Italian experts. J Prev Med Hyg. 2018;59(2):E107–E119.
  • European Centre for Disease Prevention and Control. Annual epidemiological report for 2017. Diphtheria; [cited 2020 Jan 21]. Available from: https://ecdc.europa.eu/en/publications-data/diphtheria-annual-epidemiological-report-2017
  • European Centre for Disease Prevention and Control. Tetanus - annual epidemiological report for 2017. [cited 2020 Jan 21]. Available from https://ecdc.europa.eu/en/publications-data/tetanus-annual-epidemiological-report-2017.
  • European Centre for Disease Prevention and Control. Hepatitis B - annual epidemiological report for 2017; [cited 2020 Jan 21]. Available from: https://ecdc.europa.eu/en/publications-data/hepatitis-b-annual-epidemiological-report-2017.
  • European Centre for Disease Prevention and Control. Annual epidemiological report for 2017. Pertussis; [cited 2020 Jan 21]. Available from: https://ecdc.europa.eu/en/publications-data/pertussis-annual-epidemiological-report-2017
  • Sealey KL, Belcher T, Preston A. Bordetella pertussis epidemiology and evolution in the light of pertussis resurgence. Infect Genet Evol. 2016;40:136–143.
  • European Centre for Disease Prevention and Control. Annual epidemiological report for 2017. Poliomyelitis; [cited 2020 Jan 21]. Available from: https://www.ecdc.europa.eu/en/publications-data/poliomyelitis-annual-epidemiological-report-2017
  • European Centre for Disease Prevention and Control. Haemophilus influenzae - annual epidemiological report for 2017. [cited 2020 Jan 21]. Available from: https://www.ecdc.europa.eu/en/publications-data/haemophilus-influenzae-annual-epidemiological-report-2017
  • Collins S, Ramsay M, Campbell H, et al. Invasive Haemophilus influenzae type b disease in England and Wales: who is at risk after 2 decades of routine childhood vaccination? Clin Infect Dis. 2013;57(12):1715–1721.
  • Offit PA, Quarles J, Gerber MA, et al. Addressing parents’ concerns: do multiple vaccines overwhelm or weaken the infant’s immune system? Pediatrics. 2002;109(1):124–129.
  • Nicoli F, Appay V. Immunological considerations regarding parental concerns on pediatric immunizations. Vaccine. 2017;35(23):3012–3019.
  • Miller E, Andrews N, Waight P, et al. Bacterial infections, immune overload, and MMR vaccine. Measles, mumps, and rubella. Arch Dis Child. 2003;88(3):222–223.
  • Glanz JM, Newcomer SR, Daley MF, et al. Association between estimated cumulative vaccine antigen exposure through the first 23 months of life and non-vaccine-targeted infections from 24 through 47 months of age. JAMA. 2018;319(9):906–913.
  • Stowe J, Andrews N, Taylor B, et al. No evidence of an increase of bacterial and viral infections following measles, mumps and rubella vaccine. Vaccine. 2009;27(9):1422–1425.
  • Summary of Product Characterstics. Hexyon. [ updated 22 May 2018; cited 2019 Feb 27]. Available from: https://www.ema.europa.eu/documents/product-information/hexyon-epar-product-information_en.pdf