Systematic review of the effects of pertussis vaccines in children.

OBJECTIVE To assess the efficacy and safety of whole-cell and acellular pertussis vaccines administered to children singly or within diphtheria, tetanus and pertussis (DTP) vaccines. DATA SOURCES We searched the Cochrane Library, MEDLINE, EMBASE, Biological Abstracts and Science Citation Index to December 2001. Specialised websites and bibliographies of retrieved articles and reviews were assessed. Vaccine manufacturers and investigators were contacted for additional data. REVIEW METHODS We included randomised and cohort studies comparing efficacy and/or safety of pertussis vaccines with placebo, DT, no intervention or each other. RESULTS We included 52 studies (49 randomised controlled trials (RCTs), 3 cohort studies). All tested whole-cell and acellular vaccines were significantly more effective than placebo against pertussis. Absolute efficacy of whole-cell DTP varied from 37 to 92%. One- and two-component acellular vaccines had lower absolute efficacy (67-70%), than vaccines with >/=3 components (80-84%). Whole-cell vaccines were associated with significantly higher incidences of swelling and induration (odds ratio (OR) 11.67, 95% confidence interval (CI) 8.83-15.44), fever (OR for fever >39 degrees C 3.36, 95% CI 2.06-5.49) and crying for >2h (OR 4.72, 95% CI 2.94-7.59) than placebo or DT. Differences in incidence of hypotonic hyporesponsive episodes (HHE) and convulsions were not statistically significant. Acellular pertussis vaccines did not cause a higher incidence of local signs, fever, convulsions, HHE or prolonged crying than placebo or DT. CONCLUSION All tested pertussis vaccines were efficacious. Whole-cell vaccines show variable efficacy, making interpretation of direct comparisons unreliable. Acellular vaccines with >/=3 antigenic components showed higher efficacy than one- and two-component vaccines. The adverse event profile of acellular vaccines was similar to that of placebo and considerably better than that of whole-cell vaccines.