References
- World Health Organization. DT-based combined vaccines. [cited 2019 Jan 14]. https://www.who.int/biologicals/areas/vaccines/combined_vaccines/en/
- Maman K, Zöllner Y, Greco D, et al. The value of childhood combination vaccines: from beliefs to evidence. Hum Vaccin Immunother. 2015;11(9):2132–2141.
- Skibinski DA, Baudner BC, Singh M, et al. Combination vaccines. J Glob Infect Dis. 2011;3(1):63–72.
- Le CT. Combination vaccines: choices or chaos? A practitioner’s perspective. Clin Infec Dis. 2001;33(4):S367–71.
- Bakker M, Bunge EM, Marano C, et al. Immunogenicity, effectiveness and safety of combined hepatitis A and B vaccine: a systematic literature review. Expert Rev Vaccines. 2016;15(7):829–851.
- Black S, Rappuoli R. A crisis of public confidence in vaccines. Sci Transl Med. 2010;2(61):61mr1.
- Dubé E, Laberge C, Guay M, et al. Vaccine hesitancy: an overview. Hum Vaccin Immunother. 2013;9(8):1763–1773.
- Committee NVA. Assessing the state of vaccine confidence in the United States: recommendations from the National Vaccine Advisory Committee: approved by the National Vaccine Advisory Committee on June 9, 2015 [corrected]. 433021. 2015;130(6):573–595.
- European Commission. State of vaccine confidence in the EU 2018. [cited 2019 Jan 19]. https://ec.europa.eu/health/sites/health/files/vaccination/docs/2018_vaccine_confidence_en.pdf
- U.S. Food and Drug Administration. Quadracel full prescribing information. [cited 2019 Jan 21]. https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM439903.pdf
- GlaxoSmithKline plc (GSK) pharmaceutical company. Kinrix full prescribing information. [cited 2019 Jan 21]. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Kinrix/pdf/KINRIX.PDF
- Lederle Laboratories. Tetramune approved data sheet. [cited 2019 Jan 21]. http://www.whale.to/m/tetramune.html
- GlaxoSmithKline plc (GSK) pharmaceutical company. Pediarix full prescribing information. [cited 2019 Jan 21]. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Pediarix/pdf/PEDIARIX.PDF
- U.S. Food and Drug Administration. Pentacel full prescribing information. [cited 2019 Jan 21]. https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm109810.pdf
- GlaxoSmithKline plc (GSK) pharmaceutical company. Infanrix hexa product monograph. [cited 2019 Jan 21]. https://ca.gsk.com/media/537989/infanrix-hexa.pdf
- de Greeff SC, Mooi FR, Schellekens JF, et al. Impact of acellular pertussis preschool booster vaccination on disease burden of pertussis in the Netherlands. Pediatr Infect Dis J. 2008;27(3):218–223.
- Elomaa A, He Q, Minh NN, et al. Pertussis before and after the introduction of acellular pertussis vaccines in Finland. Vaccine. 2009;27(40):5443–5449.
- Roehr B. Whooping cough outbreak hits several US states. BMJ. 2010;341:c4627.
- Cherry JD. Epidemic pertussis in 2012-the resurgence of a vaccine preventable disease. N Engl J Med. 2012;367(9):785–787.
- Amirthalingam G, Andrews N, Campbell H, et al. Effectiveness of maternal pertussis vaccination in England: an observational study. Lancet. 2014;384(9953):1521–1528.
- Carcione D, Regan AK, Tracey L, et al. The impact of parental postpartum pertussis vaccination on infection in infants: a population-based study of cocooning in Western Australia. Vaccine. 2015;33(42):5654–5661.
- van der Lee S, Stoof SP, van Ravenhorst MB, et al. Enhanced Bordetella pertussis acquisition rate in adolescents during the 2012 epidemic in the Netherlands and evidence for prolonged antibody persistence after infection. Euro Surveill. 2017;22(47):17.
- Cherry JD. Why do pertussis vaccines fail? Pediatrics. 2012;129(5):968–970.
- Lambert LC. Pertussis vaccine trials in the 1990s. J Infect Dis. 2014;209(Suppl1):S4–9.
- Klein NP, Bartlett J, Fireman B, et al. Comparative effectiveness of acellular versus whole-cell pertussis vaccines in teenagers. Pediatrics. 2013;131(6):e1716–22.
- Plotkin SA. The pertussis problem. Clin Infect Dis. 2014;58(6):830–833.
- Smits K, Pottier G, Smet J, et al. Different T cell memory in preadolescents after whole-cell or acellular pertussis vaccination. Vaccine. 2013;32(1):111–118.
- Edwards KM, Berbers GA. Immune responses to pertussis vaccines and disease. J Infect Dis. 2014;209(Suppl1):S10–15.
- Acosta AM, DeBolt C, Tasslimi A, et al. Tdap vaccine effectiveness in adolescents during the 2012 Washington state pertussis epidemic. Pediatrics. 2015;135(6):981–989.
- Cherry JD. Epidemic pertussis and acellular pertussis vaccine failure in the 21st century. Pediatrics. 2015;135(6):1130–1132.
- Sheridan SL, Ware RS, Grimwood K, et al. Number and order of whole cell pertussis vaccines in infancy and disease protection. JAMA. 2012;308(5):454–456.
- Witt MA, Arias L, Katz PH, et al. Reduced risk of pertussis among persons ever vaccinated with whole cell pertussis vaccine compared to recipients of acellular pertussis vaccines in a large US cohort. Clin Infect Dis. 2013;56(9):1248–1254.
- Klein NP, Bartlett J, Fireman B, et al. Waning Tdap effectiveness in adolescents. Pediatrics. 2016;137(3):e20153326.
- van Twillert I, Bonačić Marinović AA, Kuipers B, et al. Impact of age and vaccination history on long-term serological responses after symptomatic B. pertussis infection, a high dimensional data analysis. Sci Rep. 2017;7:40328.
- Chiappini E, Stival A, Galli L, et al. Pertussis re-emergence in the post-vaccination era. BMC Infect Dis. 2013;13:151.
- Swamy GK, Wheeler SM. Neonatal pertussis, cocooning and maternal immunization. Expert Rev Vaccines. 2014;13(9):1107–1114.
- McGirr A, Fisman DN. Duration of pertussis immunity after DTaP immunization: A meta-analysis. Pediatrics. 2015;135(2):331–343.
- Ausiello CM, Cassone A. Acellular pertussis vaccines and pertussis resurgence: revise or replace? MBio. 2014;5(3):e01339–14.
- Miller E, Ashworth LA, Redhead K, et al. Effect of schedule on reactogenicity and antibody persistence of acellular and whole-cell pertussis vaccines: value of laboratory tests as predictors of clinical performance. Vaccine. 1997;15(1):51–60.
- Tiru M, Hallander HO, Gustafsson L, et al. Diphtheria antitoxin response to DTP vaccines used in Swedish pertussis vaccine trials, persistence and projection for timing of booster. Vaccine. 2000;18(21):2295–2306.
- Wu Y, Gao Y, Zhu B, et al. Antitoxins for diphtheria and tetanus decline more slowly after vaccination with DTwP than with DTaP: a study in a Chinese population. Vaccine. 2014;32(22):2570–2573.
- Sangal L, Joshi S, Anandan S, et al. Resurgence of diphtheria in north Kerala, India, 2016: laboratory supported case-based surveillance outcomes. Front Public Health. 2017;5:218.
- Husada D, Puspitasari D, Kartina L, et al. Six-year surveillance of diphtheria outbreak in Indonesia. Open Forum Infect Dis. 2017;4(Suppl1):S244.
- Muhamad Ramdan I, Susanti R, Ifroh RH, et al. Risk factors for diphtheria outbreak in children aged 1–10 years in East Kalimantan Province, Indonesia [version 1; peer review: 1 approved]. F1000Res. 2018;7:1625.
- Breukels MA, Spanjaard L, Sanders LAM, et al. Immunological characterization of conjugated Haemophilus influenzae type b vaccine failure in infants. Clin Infect Dis. 2001;32(12):1700–1705.
- Rijkers GT, Vermeer-de Bondt PE, Spanjaard L, et al. Return of Haemophilus influenzae type b infections. Lancet. 2003;361(9368):1563–1564.
- McVernon J, Andrews N, Slack MP, et al. Risk of vaccine failure after Haemophilus influenzae type b (Hib) combination vaccines with acellular pertussis. Lancet. 2003;361(9368):1521–1523.
- Johnson NG, Ruggeberg JU, Balfour GF, et al. Haemophilus influenzae type b reemergence after combination immunization. Emerg Infect Dis. 2006;12(6):937–941.
- Greenberg DP, Wong VK, Partridge S, et al. Safety and immunogenicity of a combination diphtheria-tetanus toxoids-acellular pertussis-hepatitis B vaccine administered at two, four and six months of age compared with monovalent hepatitis B vaccine administered at birth, one month and six months of age. Pediatr Infect Dis J. 2002;21(8):769–776.
- Tichmann I, Preidel H, Grunert D, et al. Comparison of the immunogenicity and reactogenicity of two commercially available hexavalent vaccines administered as a primary vaccination course at 2, 4 and 6 months of age. Vaccine. 2005;23(25):3272–3279.
- The European Medicines Agency. Questions and answers on the suspension of Hexavac. [cited 2019 Oct 8]. https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-suspension-hexavac_en.pdf
- The European Medicines Agency. Public statement on Hexavac. Withdrawal of marketing authorisation in the European Union. [cited 2019 Oct 8]. https://www.ema.europa.eu/en/documents/public-statement/public-statement-hexavac-withdrawal-marketing-authorisation-european-union_en.pdf
- 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.
- Knol M, Urbanus A, Swart E, et al. Large ongoing measles outbreak in a religious community in the Netherlands since May 2013. Euro Surveill. 2013;18(36):20580.
- Pegorie M, Shankar K, Welfare WS, et al. Measles outbreak in Greater Manchester, England, October 2012 to September 2013: epidemiology and control. Euro Surveill. 2014;19(49):20982.
- Hahné SJ, Nic Lochlainn LM, van Burgel ND, et al. Measles outbreak among previously immunized healthcare workers, the Netherlands, 2014. J Infect Dis. 2016;214(12):1980–1986.
- Keenan A, Ghebrehewet S, Vivancos R, et al. Measles outbreaks in the UK, is it when and where, rather than if? A database cohort study of childhood population susceptibility in Liverpool, UK. BMJ Open. 2017;7(3):e014106.
- Siani A. Measles outbreaks in Italy: A paradigm of the re-emergence of vaccine-preventable diseases in developed countries. Prev Med. 2019;121:99–104.
- Rosen JB, Rota JS, Hickman CJ, et al. Outbreak of measles among persons with prior evidence of immunity, New York City, 2011. Clin Infect Dis. 2014;58(9):1205–1210.
- McCarthy M. Measles outbreak linked to Disney theme parks reaches five states and Mexico. BMJ. 2015;350:h436.
- Lewnard JA, Grad YH. Vaccine waning and mumps re-emergence in the United States. Sci Transl Med. 2018;10(433):eaao5945.
- Chiew M, Dey A, Martin N, et al. Australian vaccine preventable disease epidemiological review series: measles 2000–2011. Commun Dis Intell Q Rep. 2015;39(1):E1–9.
- Kang HJ, Han YW, Kim SJ, et al. An increasing, potentially measles-susceptible population over time after vaccination in Korea. Vaccine. 2017;35(33):4126–4132.
- Gomber S, Arora SK, Das S, et al. Immune response to second dose of MMR vaccine in Indian children. Indian J Med Res. 2011;134(3):302–306.
- Ma R, Lu L, Zhangzhu J, et al. A measles outbreak in a middle school with high vaccination coverage and evidence of prior immunity among cases, Beijing, P.R. China. Vaccine. 2016;34(15):1853–1860.
- Poland GA, Jacobson RM. The re-emergence of measles in developed countries: time to develop the next-generation measles vaccines? Vaccine. 2012;30(2):103–104.
- Haralambieva IH, Kennedy RB, Ovsyannikova IG, et al. Current perspectives in assessing humoral immunity after measles vaccination. Expert Rev Vaccines. 2019;18(1):75–87.
- Plotkin SA. Mumps vaccines: do we need a new one? Pediatr Infect Dis J. 2013;32(4):381–382.
- The Centers for Disease Control and Prevention. Vaccination safety. [cited 2019 Oct 9]. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/safety.pdf
- Di Pasquale A, Bonanni P, Garçon N, et al. Vaccine safety evaluation: practical aspects in assessing benefits and risks. Vaccine. 2016;34(52):6672–6680.
- Joshi J, Das MK, Polpakara D, et al. Vaccine safety and surveillance for adverse events following immunization (AEFI) in India. Indian J Pediatr. 2018;85(2):139–148.
- Ellenberg SS. Evaluating the safety of combination vaccines. Clin Infect Dis. 2001;33(Suppl4):S319–22.
- The Centers for Disease Control and Prevention. Combination vaccines. [cited 2019 Oct 12]. https://www.cdc.gov/vaccines/parents/why-vaccinate/combination-vaccines.html
- World Health Organization. Vaccine-preventable diseases and vaccines. [cited 2019 Oct 12]. https://www.who.int/ith/ITH-Chapter6.pdf.
- Sadoh AE, Nwaneri DU, Ogboghodo BC, et al. Comparison of adverse events following pentavalent and diphtheria-tetanus-pertussis vaccines among Nigerian children. Pharmacoepidemiol Drug Saf. 2018;27(1):119–122.
- Farrington P, Pugh S, Colville A, et al. A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet. 1995;345(8949):567–569.
- Sun Y, Christensen J, Hviid A, et al. Risk of febrile seizures and epilepsy after vaccination with diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and Haemophilus influenzae type B. JAMA. 2012;307:823–831.
- Walker AM, Jick H, Perera DR, et al. Diphtheria-tetanus-pertussis immunization and sudden infant death syndrome. Am J Public Health. 1987;77(8):945–951.
- Traversa G, Spila-Alegiani S, Bianchi C, et al. Sudden unexpected deaths and vaccinations during the first two years of life in Italy: A case series study. PLoS ONE. 2011;6(1):e16363.
- Puliyel J, Sathyamala C. Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency. Indian J Med Ethics. 2018;3(1):43–47.
- Miller E, Andrews N, Stowe J, et al. Risks of convulsion and aseptic meningitis following measles-mumps-rubella vaccination in the United Kingdom. Am J Epidemiol. 2007;165(6):704–709.
- Kamali Aghdam M, Sadeghzadeh M, Fakhimi S, et al. Evaluation of aseptic meningitis following measles-mumps-rubella vaccine in children admitted due to febrile convulsion. Int J Pediatr. 2018;6(8):8147–8152.
- Mamishi S, Sarkardeh M, Pourakbari B, et al. Aseptic meningitis after measles–mumps–rubella (MMR) vaccination. Br J Biomed Sci. 2016;73(2):84–86.
- Kuwabara N, Ching MS. A review of factors affecting vaccine preventable disease in Japan. Hawaii J Med Public Health. 2014;73(12):376–381.
- Chen RT, Pool V, Takahashi H, et al. Combination vaccines: postlicensure safety evaluation. Clin Infect Dis. 2001;33(Suppl4):S327–33.
- Tavares Da Silva F, Di Pasquale A, Yarzabal JP, et al. Safety assessment of adjuvanted vaccines: methodological considerations. Hum Vaccin Immunother. 2015;11(7):1814–1824.
- Puliyel J, Naik P. Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization-a critique [version 2; referees: 2 approved]. F1000Res. 2018;7:243.
- Shimabukuro TT, Nguyen M, Martin D, et al. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2015;33(36):4398–4405.
- Chen RT, Shimabukuro TT, Martin DB, et al. Enhancing vaccine safety capacity globally: A lifecycle perspective. Vaccine. 2015;33(4):D46–54.
- The Centers for Disease Control and Prevention. Vaccine adverse event reporting system (VAERS) database information. [cited 2019 Sept 3]. https://www.fda.gov/vaccines-blood-biologics/vaccine-adverse-events/vaccine-adverse-event-reporting-system-vaers-database-information
- Davis RL. Vaccine safety surveillance systems: critical elements and lessons learned in the development of the US vaccine safety datalink’s rapid cycle analysis capabilities. Pharmaceutics. 2013;5(1):168–178.
- Goldman GS, Miller NZ. Relative trends in hospitalizations and mortality among infants by the number of vaccine doses and age, based on the vaccine adverse event reporting system (VAERS), 1990–2010. Hum Exp Toxicol. 2012;31(10):1012–1021.
- Munoz FM. Safer pertussis vaccines for children: trading efficacy for safety. Pediatrics. 2018;142(1):e20181036.
- The Centers for Disease Control and Prevention. Vaccine safety datalink (VSD). [cited 2019 Dec 17]. https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html
- McNeil MM, Gee J, Weintraub ES, et al. The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety. Vaccine. 2014;32(42):5390–5398.
- Griffin MR, Braun MM, Bart KJ. What should an ideal vaccine postlicensure safety system be? Am J Public Health. 2009;99(Suppl2):S345–50.
- Moro PL, Haber P, McNeil MM. Challenges in evaluating post-licensure vaccine safety: observations from the Centers for Disease Control and Prevention. Expert Rev Vaccines. 2019;18(10):1091–1101.
- McClenathan BM, Edwards KM. Vaccine safety: an evolving evidence‐based science. Br J Clin Pharmacol. 2019;85(12):2649–2651.
- Waldman EA, Luhm KR, Monteiro SAMG, et al. Surveillance of adverse effects following vaccination and safety of immunization programs. Rev Saúde Pública. 2011;45(1):173–184.
- Cunningham AL, Garçon N, Leo O, et al. Vaccine development: from concept to early clinical testing. Vaccine. 2016;34(52):6655–6664.
- Brito LA, Malya P, O’Hagan DT. Vaccine adjuvant formulations: A pharmaceutical perspective. Semin Immunol. 2013;25(2):130–145.
- Liang JL, Tiwari T, Moro P, et al. Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2018;67(2):1–44.
- Bandyopadhyay AS, Garon J, Seib K, et al. Polio vaccination: past, present and future. Future Microbiol. 2015;10(5):791–808.
- Kraan H, Ten HR, van der Maas L, et al. Incompatibility of lyophilized inactivated polio vaccine with liquid pentavalent whole-cell-pertussis-containing vaccine. Vaccine. 2016;34(38):4572–4578.
- Wan Y, Hickey JM, Bird C, et al. Development of stabilizing formulations of a trivalent inactivated poliovirus vaccine in a dried state for delivery in the nanopatch™ microprojection array. J Pharm Sci. 2018;107(6):1540–1551.
- Otto RB, Burkin K, Amir SE, et al. Patterns of binding of aluminum-containing adjuvants to Haemophilus influenzae type b and meningococcal group C conjugate vaccines and components. Biologicals. 2015;43(5):355–362.
- World Health Organization. Vaccine safety basics. E-learning course. Module 2: types of vaccine and adverse reactions. Combination vaccines. [cited 2020 Jan 8]. https://www.who.int/vaccine_safety/initiative/tech_support/Part-2.pdf
- Morefield GL. A rational, systematic approach for the development of vaccine formulations. Aaps J. 2011;13(2):191–200.
- Jatana SK, Nair M. Combination Vaccines. Med J Armed Forces India. 2007;63(2):167–171.
- Saso A, Kampmann B. Vaccine responses in newborns. Semin Immunopathol. 2017;39(6):627–642.
- World Health Organization. The immunological basis for immunization series. Module 22: hepatitis B. [cited 2020 Jan 12]. https://apps.who.int/iris/bitstream/handle/10665/77755/9789241504751_eng.pdf
- Konini A, Kang M, Moghadas SM. Simulating immune interference on the effect of a bivalent glycoconjugate vaccine against Haemophilus influenzae serotypes “a” and “b”. Can J Infect Dis Med Microbiol. 2016;2016:5486869.
- Rathi N. “FAQs on vaccines and immunization practices” In: Combination vaccines, 2nd. Uttar Pradesh (India): Jaypee Brothers Medical Publishers; 2015. p. 323–328. Chapter 29.
- Dellepiane N, Griffiths E, Milstien JB. New challenges in assuring vaccine quality. Bull World Health Organ. 2000;78(2):155–162.
- Schlingmann B, Castiglia KR, Stobart CC, et al. Polyvalent vaccines: high-maintenance heroes. PLoS Pathog. 2018;14(4):e1006904.
- The Centers for Disease Control and Prevention. Recommended child and adolescent immunization schedule for ages 18 years or younger. [cited 2020 Apr 27]. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
- The Centers for Disease Control and Prevention. Preventing perinatal hepatitis b virus transmission: a guide for introducing and strengthening hepatitis b birth dose vaccination. [cited 2020 Apr 28]. https://apps.who.int/iris/bitstream/handle/10665/208278/9789241509831_eng.pdf
- The Centers for Disease Control and Prevention. Pediarix vaccine questions and answers for healthcare providers. [cited 2020 Apr 29]. https://www.cdc.gov/vaccines/vpd/hepb/hcp/faqs-hcp-pediarix.html
- The Centers for Disease Control and Prevention. About Hib vaccines. [cited 2020 Apr 29]. https://www.cdc.gov/vaccines/vpd/hib/hcp/about-vaccine.html
- Feikema SM, Klevens RM, Washington ML, et al. Extraimmunization among US children. JAMA. 2000;283(10):1311–1317.
- Ask CDC - Vaccines & Immunizations. Is there any danger from receiving extra doses of a vaccine? [cited 2020 May 4]. https://www.cdc.gov/cdc-info/vaccines-immunizations.html
- Moro PL, Arana J, Marquez PL, et al. Is there any harm in administering extra-doses of vaccine to a person? Excess doses of vaccine reported to the vaccine adverse event reporting system (VAERS), 2007–2017. Vaccine. 2019;37(28):3730‐3734.