Combined, reduced-antigen content tetanus, diphtheria, and acellular pertussis vaccine (Boostrix®)†: A review of its use as a single-dose booster immunization in individuals aged 1064 years in the US

BioDrugs

Volumn 23, Issue 4, 2009, Pages 253-267

  Plosker, Greg L ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Adolescents; Adults; Boostrix ; Diphtheria; Immunogenicity; Pertussis; Reactogenicity; Reduced antigen; Tdap; Tetanus; Vaccine

Indexed keywords

ANTIBODY; ANTIGEN; DIPHTHERIA ANTIBODY; DIPHTHERIA PERTUSSIS TETANUS VACCINE; DIPHTHERIA VACCINE; HEMAGGLUTININ ANTIBODY; INFLUENZA VACCINE; MENINGOCOCCUS VACCINE; PERTACTIN ANTIBODY; PERTUSSIS ANTIBODY; TETANUS ANTIBODY; TETANUS TOXOID; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ANTIBODY BLOOD LEVEL; ANTIBODY RESPONSE; ARTHRALGIA; ARTICLE; ASTHMA; CLINICAL TRIAL; COHORT ANALYSIS; COMPARATIVE STUDY; COMPLIANCE (PHYSICAL); CONVULSION; DIABETES MELLITUS; DIPHTHERIA; DRUG EFFECT; DRUG USE; ENCEPHALITIS; FACIAL NERVE PARALYSIS; FATIGUE; FEVER; GASTROINTESTINAL SYMPTOM; HEADACHE; HOUSEHOLD; HUMAN; HYPOKALEMIA; IMMUNIZATION; IMMUNOGENICITY; INJECTION SITE; INJECTION SITE CONTUSION; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE SWELLING; LYMPHADENITIS; MORBIDITY; MYALGIA; MYOCARDITIS; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PARESTHESIA; PERTUSSIS; POPULATION; PRACTICE GUIDELINE; PRESYNCOPE; PRIORITY JOURNAL; PROTECTION; RASH; RECOMMENDED DRUG DOSE; SEROLOGY; SHIVERING; SORE THROAT; SYMPTOM; TETANUS; UNITED STATES; URTICARIA; VACCINATION;

ADOLESCENT; ADULT; CHILD; DIPHTHERIA; DIPHTHERIA-TETANUS-PERTUSSIS VACCINE; DOSE-RESPONSE RELATIONSHIP, IMMUNOLOGIC; HUMANS; IMMUNIZATION, SECONDARY; MIDDLE AGED; TETANUS; UNITED STATES; VACCINES, ACELLULAR; VACCINES, COMBINED; WHOOPING COUGH; YOUNG ADULT;

EID: 69349096140     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.2165/11202770-000000000-00000     Document Type: Article

References (51)

1. Centers for Disease Control. Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures: recommendations of the Immunization Practices Advisory Committee (ACI). MMWR Recomm Rep 1991; 40 (RR-10): 1-28
2. Broder KR, Cortese MM, Skender JK, et al. Preventing tetanus, diphtheria, and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2006 Mar 24; 55 (RR-3): 1-34
3. Kretsinger K, Broder KR, Cortese MM, et al. Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel. MMWR Recomm Rep 2006 Dec 15; 55 (RR-17): 1-37
4. Cherry JD. The epidemiology of pertussis: a comparison of the epidemiology of the disease pertussis with the epidemiology of Bordetella pertussis infection. Pediatrics 2005 May; 115 (5): 1422-1427
5. Centers for Disease Control. Final 2007 reports of nationally notifiable infectious diseases. MMWR 2008 Aug 22; 57 (33): 901, 903-913
6. Centers for Disease Control. Pertussis Surveillance Report - 10/6/08: weeks 1-52, 2007 (final data) [CDC/NCIRD/DBD/MVPD]. Atlanta (GA): Centers for Disease Control, 2008
7. Centers for Disease Control. Summary of notifiable diseases - United States, 2004. MMWR Morb Mortal Wkly Rep 2006 Jun 16; 53 (53): 1-79
8. Cortese MM, Baughman AL, Brown K, et al. A 'new vention new opportunities through adult vaccination. Am J Prev Med 2007 Mar; 32 (3): 177-185
9. Tan T, Trindade E, Skowronski D. Epidemiology of pertussis. Pediatr Infect Dis J 2005 May; 24 (5): S10-8
10. McNabb SJ, Jajosky RA, Hall-Baker PA, et al. Summary of notifiable diseases - United States, 2006. MMWR Morb Mortal Wkly Rep 2008 Mar 21; 55 (53): 1-92
11. Edwards KM. Overview of pertussis: focus on epidemiology, sources of infection, and long term protection after infant vaccination. Pediatr Infect Dis J 2005 Jun; 24 (6): S104-8
12. American Academy of Pediatrics Committee on Infectious Diseases. Prevention of pertussis among adolescents; recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine. Pediatrics 2006; 117: 965-978
13. Lee GM, Lett S, Schauer S, et al. Societal costs and morbidity of pertussis in adolescents and adults. Clin Infect Dis 2004 Dec 1; 39 (11): 1572-1580
14. Lee GM, Murphy TV, Lett S, et al. Cost effectiveness of pertussis vaccination in adults. Am J Prev Med 2007 Mar; 32 (3): 186-193
15. Caro JJ, Getsios D, El-Hadi W, et al. Pertussis immunization of adolescents in the United States: an economic evaluation. Pediatr Infect Dis J 2005 May; 24 Suppl. 5: S75-82
16. Hay JW, Ward JI. Economic considerations for pertussis booster vaccination in adolescents. Pediatr Infect Dis J 2005 Jun; 24 (6 Suppl.): S127-33
17. Purdy KW, Hay JW, Botteman MF, et al. Evaluation of strategies for use of acellular pertussis vaccine in adolescents and adults: a cost-benefit analysis. Clin Infect Dis 2004 Jul 1; 39 (1): 20-28
18. Lee GM, LeBaron C, Murphy TV, et al. Pertussis in adolescents and adults: should we vaccinate? Pediatrics 2005 Jun; 115 (6): 1675-1684
19. Halperin SA. Pertussis: a disease and vaccine for all ages. N Engl J Med 2005 Oct 13; 353 (15): 1615-1617
20. Yeh SH, Mink CM. Shift in the epidemiology of pertussis infection: an indication for pertussis vaccine boosters for adults? Drugs 2006; 66 (6): 731-741
21. Bisgard KM, Pascual FB, Ehresmann KR, et al. Infant pertussis: who was the source? Pediatr Infect Dis J 2004 Nov; 23 (11): 985-989
22. Centers for Disease Control and Prevention. Use of diphtheria toxoid-tetanus toxoid-acellular pertussis vaccine as a five-dose series: supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2000; 49 (RR-13): 1-8
23. Rennels MB. Extensive swelling reactions occurring after booster doses of diphtheria-tetanus-acellular pertussis vaccines. Semin Pediatr Infect Dis 2003; 14: 196-198
24. Rennels MB, Black S, Woo EJ, et al. Safety of a fifth dose of diphtheria and tetanus toxoid and acellular pertussis vaccine in children experiencing extensive, local reactions to the fourth dose. Pediatr Infect Dis J 2008 May; 27 (5): 464-465
25. Casey JR, Pichichero ME. Acellular pertussis vaccine safety and efficacy in children, adolescents and adults. Drugs 2005; 65 (10): 1367-1389
26. GlaxoSmithKline. Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) US prescribing information. Research Triangle Park (NC): GlaxoSmithKline, 2009 Jan
27. Frampton JE, Keating GM. Reduced-antigen, combined diphtheria, tetanus, and acellular pertussis vaccine (Boostrix): a review of its use as a single-dose booster immunization. Biodrugs 2006; 20 (6): 371-389
28. GlaxoSmithKline. Infanrix (diphtheria and tetanus toxoids and acellular pertussis vaccine, adsorbed) US prescribing information. Research Triangle Park (NC): GlaxoSmithKline, 2009 Mar
29. Sanofi Pasteur. Adacel (tetanus toxoid, reduced diphtheria toxoid and acel-lular pertussis vaccine adsorbed) US prescribing information. Swiftwater (PA): Sanofi Pasteur, 2009 Jan
30. Frampton JE, Keam SJ. Reduced-antigen, combined diphtheria-tetanus- in pertussis pre-acellular pertussis vaccine, adsorbed (Boostrix US formulation): use as a single-dose booster immunization in adolescents aged 10-18 years. Paediatr Drugs 2006; 8 (3): 189-195
31. Pichichero ME, Blatter MM, Kennedy WA, et al. Acellular pertussis vaccine booster combined with diphtheria and tetanus toxoids for adolescents. Pediatrics 2006 Apr; 117: 1084-1093
32. Blatter M, Friedland LR, Weston WM, et al. Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular per-tussis vaccine in adults 19-64 years of age. Vaccine 2009 Jan 29; 27 (5): 765-772
33. Schmitt H-J, Wirsing 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
34. Schmitt HJ, Schulnd A, Knuf M, et al. Clinical experience of a tricomponent acellular pertussis vaccine combined with diphtheria and tetanus toxoids for primary vaccination in 22,505 infants. J Pediatr 1996 Nov; 129 (5): 695-701
35. Friedland L, Weston W, Howe B. Immunogenicity of coadministered Tdap and MCV4 vaccines compared to separately administered vaccines [poster no. G-1699]. 47th Interscience Conference on Antimicrobial Agents and Chemotherapy; 2007 Sep 17-20; Chicago (IL)
36. GlaxoSmithKline. Study no.: 105753 (Tdap 0.3-006). A phase IV, randomized, partially blinded multicenter study to evaluate the safety and immunogenicity of a booster vaccination with diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap Boostrix ] co-administered intramuscularly with Aventis-(erogroups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra ) as compared to the administration of either vaccine alone in healthy adolescents 11-18 years of age [online]. Available from URL: http://www.gsk-clinicalstudyregister.com [Accessed 2009 Jun 9]
37. GlaxoSmithKline. Study no.: 106323 (Tdap 0.3-0.008). A phase IIIb, randomized, controlled, open-labelled, multicenter study of GSK tanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, vaccine (Boostrix ) when co-administered with GSK influenza vaccine (Fluarix ) in subjects 19 years of age and older [online]. Available from URL: http://www.gsk-clinicalstudyregister.com/files/pdf/ 20087.pdf [Accessed 2009 Apr 14]
38. Pichichero ME, Casey JR, Francis AB, et al. Acellular pertussis vaccine boosters combined with diphtheria and tetanus toxoid boosters for adolescents: safety and immunogenicity assessment when preceded by different 5-dose DTaP/DTwP schedules. Clin Pediatr 2006 Sep; 45 (7): 613-620
39. GlaxoSmithKline. Study no.: 110080 (Tdap 0.3-009 ext: 007 year 1). A phase IIIb, controlled, multicenter study to evaluate antibody persistence at 1, 3, 5 and 10 years following administration of a single dose of Tdap vaccine to healthy subjects, 19 years of age and older in the study 106316 (Tdap 0.3-007) [online]. Available from URL: http://www.gsk-clinicalstudyregister.com/ files/pdf/20233.pdf [Accessed 2009 Apr 14]
40. McNeil SA, Noya F, Dionne M, et al. Comparison of the safety and im-munogenicity of concomitant and sequential administration of an adult formulation tetanus and diphtheria toxoids adsorbed combined with acellular pertussis (Tdap) vaccine and trivalent inactivated influenza vaccine in adults. Vaccine 2007 Apr 30; 25 (17): 3464-3474
41. Klein NP, Hansen J, Lewis N, et al. Post-marketing safety evaluation of a tetanus toxoid, reduced diptheria toxoid, and acellular pertussis (Tdap) vaccine administered to a cohort of adolescents in a U.S. health maintenance organization [abstract no. G-2085 plus poster]. 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy and 46th Annual Meeting of the Infectious Diseases Society of America; 2008 Oct 25-28; Washington, DC
42. Weston W, Friedland L, Howe B. Reactogenicity of concomitant and separately administered Tdap and MCV4 vaccines [poster no. G-1700]. 47th Interscience Conference of Antimicrobial Agents and Chemotherapy; 2007 Sep 17-20; Chicago (IL)
43. GlaxoSmithKline. Study no.: 104154 (Tdap 0.3-005). Phase IV, open, prospective study of the safety of GSK Biologicals' Bootrix® (tetanus toxoid, reduced diphtheria toxoide and acellular pertussis vaccine, adsorbed) administered to a cohort of adolescents in a US health maintenance organization (HMO) (Post-Marketing Boostrix Safety Study) [online]. Available from URL: http://www.gsk-clinicalstudyregister.com [Accessed 2009 Jun 9] tetanus toxoid, reduced
44. Centers for Disease Control. Prevention of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants recommendations meningococcal of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2008 May 30; 57 (RR-4): 1-51
45. McIntyre PB, Burgess MA, Egan A, et al. Booster vaccination of adults with reduced-antigen-content diphtheria, tetanus and pertussis vaccine: im-munogenicity 5 years post-vaccination. Vaccine 2009 Feb 11; 27 (7): 1062-1066
46. Edelman K, He Q, Mäkinen J, et al. Immunity to pertussis 5 years after booster immunization during adolescence. Clin Infect Dis 2007 May 15; 44 (10): 1271-7
47. Mitka M. Age range widens for pertussis vaccine: boosters advised for adolescents and adults. JAMA 2006 Feb 22; 295 (8): 871-872
48. Centers for Disease Control. Vaccination coverage among U.S. adults national immunization survery - adult, 2007 [online]. Available from URL: http:// www.cdc.gov/vaccines/stats-surv/nis/downloads/nis-adult-summer-2007.pdf [Accessed 2009 Apr 14]
49. Centers for Disease Control. Vaccination coverage among adolescents aged 13-17 years - United States, 2007 [published erratum appears in MMWR Morb Mortal Wkly Rep 2009 Jan 16; 58 (1): 10]. MMWR Morb Mortal Wkly Rep 2008 Oct 10; 57 (40): 1100-1103
50. Centers for Disease Control. Recommended immunization schedules for persons aged 0 through 18 years United States, 2009 [published erratum appears in MMWR Morb Mortal Wkly Rep 2009 Jan 9; 57 (53): 1419]. MMWR Morb Mortal Wkly Rep 2009 Jan 2; 57 (51 and 52): Q1-4
51. Evaluation of safety and immunogenicity of co-administered HPV vaccine with other vaccines in healthy female subjects [ClinicalTrials.gov identifier NCT00369824]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://www.clinicaltrials.gov [Accessed 2009 Aug 6]