A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine

New England Journal of Medicine

Volumn 334, Issue 6, 1996, Pages 349-355

  Gustafsson, Lennart ^a   Hallander, Hans O ^b   Olin, Patrick ^a,b   Reizenstein, Elisabet ^b   Storsaeter, Jann ^a  

^a SACHS CHILDREN S HOSPITAL   (Sweden)

^b SWEDISH INSTITUTE FOR INFECTIOUS DISEASE CONTROL   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS VACCINE; DIPHTHERIA TETANUS VACCINE; IMMUNOGLOBULIN G;

ANTIBODY BLOOD LEVEL; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYANOSIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEVER; HUMAN; INFANT; INFECTION PREVENTION; INJECTION PAIN; INTRAMUSCULAR DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; NEWBORN; PALLOR; PERTUSSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ANTIBODIES, BACTERIAL; ANTIGENS, BACTERIAL; BORDETELLA PERTUSSIS; DIPHTHERIA TOXOID; DIPHTHERIA-TETANUS VACCINE; DIPHTHERIA-TETANUS-PERTUSSIS VACCINE; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMMUNOGLOBULIN G; INFANT; MALE; PERTUSSIS VACCINE; TETANUS TOXOID; TREATMENT OUTCOME; VACCINES, COMBINED; VACCINES, INACTIVATED; VIRULENCE FACTORS, BORDETELLA; WHOOPING COUGH;

EID: 0030058665     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJM199602083340602     Document Type: Article

References (30)

1. Moxon ER, Rappuoli R. Haemophilus influenzae infections and whooping cough Lancet 1990,335:1324-9
2. Cherry CD, Brunell PA, Golder GS, Karzon DT. Report of the Task Force on Pertussis and Pertussis Immunization - 1988. Pediatrics 1988,81 Suppl: 939-84.
3. Noble GR, Bernier RH, Esher EC, et al Acellular and whole-cell pertussis vaccines in Japan, report of a visit by US scientists. JAMA 1987;257.1351-6.
4. Feldman S, Perry S, Andrew M, Jones L, Moffitt JE. Comparison of acellular (B type) and whole-cell pertussis-component diphtheria-tetanus-pertussis vaccines as the first booster immunization in 15- to 24-month-old children. J Pediatr 1992;121:857-61. [Erratum, J Pediatr 1993;123 842.]
5. Cherry JD. Pertussis: the trials and tribulations of old and new pertussis vaccines. Vaccine 1992,10.1033-8
6. Ad Hoc Group for the Study of Pertussis Vaccines. Placebo-controlled trial of two acellular pertussis vaccines in Sweden - protective efficacy and adverse events. Lancet 1988,1.955-60. [Erratum, Lancet 1988,1.1238 ]
7. Storsaeter J, Olin P Relative efficacy of two acellular pertussis vaccines during three years of passive surveillance. Vaccine 1992;10 142-4.
8. Edwards KM, Meade BM, Decker MD, et al. Comparison of 13 acellular pertussis vaccines, overview and serologic response. Pediatrics 1995;96 548-57.
9. Trollfors B, Taranger J, Lagergård T, et al. A placebo-controlled trial of a pertussis-toxoid vaccine. N Engl J Med 1995;333:1045-50.
10. Shahin RD, Brennan MJ, Li ZM, Meade BD, Manclark CR Characterization of the protective capacity and immunogenicity of the 69-kD outer membrane protein of Bordetella pertussis. J Exp Med 1990;171 63-73.
11. Gustafsson L, Hallander HO, Olin P, Reizenstein E, Storsaeter J. Efficacy trial of acellular pertussis vaccine technical report, Trial I, with results of preplanned analysis of safety, efficacy and immunogentcity. Stockholm, Sweden Swedish Institute for Infectious Disease Control, 1995 20-70. (Contract no N01-AI-15125.)
12. Olin P Acellular pertussis vaccines - a question of efficacy. J Hosp Infect 1995;30 Suppl:503-7.
13. Cody CL, Baraff LJ, Cherry JD, Marcy SM, Manclark CR. Nature and rates of adverse reactions associated with DTP and DT immunizations in infants and children Pediatrics 1981;68.650-60.
14. Storsaeter J, Olin P, Renemar B, et al. Mortality and morbidity from invasive bacterial infections during a clinical trial of acellular pertussis vaccines in Sweden Pediatr Infect Dis 1988,7:637-45.
15. Hallander HO, Reizenstein I, Renemar B, Rasmuson G, Mardin L, Olin P. Comparison of nasopharyngeal aspirates with swabs for culture of Bordetella pertussis J Clin Microbiol 1993;31:50-2.
16. Regan J, Lowe F. Enrichment medium for the isolation of Bordetella. J Clin Microbiol 1977,6 303-9.
17. Reizenstein E, Johansson B, Mardin L, Abens J, Möllby R, Hallander HO. Diagnostic evaluation of polymerase chain reaction discriminative for Bordetella pertussis, B. parapertussis, and B. bronchiseptica. Diagn Microbiol Infect Dis 1993,17 185-91.
18. Meade BD, Deforest A, Edwards KM, et al. Description and evaluation of serologic assays used in a multicenter trial of acellular pertussis vaccines Pediatrics 1995;96.570-5.
19. Reizenstein E, Hallander HO, Blackwelder WC, Kuhn I, Ljungman M, Möllby R Comparison of five calculation modes for antibody ELISA procedures using pertussis serology as a model. J Immunol Methods 1995,183. 279-90.
20. WHO meeting on case definition of pertussis Geneva, 10-11 January 1991 Geneva World Health Organization, 1991:4-5. (Issue no. MIN/EPI/PERT/ 91.1.)
21. Hallander HO, Storsaeter J, Mollby R. Evaluation of serology and nasopharyngeal cultures for diagnosis of pertussis in a vaccine efficacy trial. J Infect Dis 1991,163.1046-54.
22. Kalbfleisch JD, Prentice RL. The statistical analysis of failure time data. New York. John Wiley, 1980
23. Reed GF, Meade BD, Steinhoff MC. The reverse cumulative distribution plot: a graphic method for exploratory analysis of antibody data. Pediatrics 1995;96 600-3.
24. Anderson EL, Belshe RB, Bartram J. Differences in reactogenicity and antigenicity of acellular and standard pertussis vaccines combined with diphtheria and tetanus in infants. J Infect Dis 1988;157:731-7
25. Blumberg DA, Mink CM, Cherry JD, et al. Comparison of acellular and whole-cell pertussis-component diphtheria-tetanus-pertussis vaccines in infants. J Pediatr 1991;119 194-204.
26. Englund JA Glezen WP, Barreto J. Controlled study of a new five-component acellular pertussis vaccine in adults and young children J Infect Dis 1992,166:1436-41.
27. Decker MD, Edwards KM, Steinhoff MC, et al. Comparison of 13 acellular pertussis vaccines: adverse reactions Pediatrics 1995;96:557-66.
28. 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;334:341-8.
29. Pertussis In: Peter G, ed. 1994 Red book: report of the committee on infectious diseases 23rd ed Elk Grove Village, Ill.: American Academy of Pediatrics, 1994.355-67
30. Edwards KM, Decker MD, Halsey NA, et al Differences in antibody response to whole-cell pertussis vaccines Pediatrics 1991:88:1019-23.