Invasive bacterial infections during an efficacy trial of acellular pertussis vaccines--implications for future surveillance in pertussis vaccine programmes.
During a placebo controlled trial of acellular pertussis vaccines a cluster of invasive bacterial infections with fatal outcome occurred among vaccinated children as compared with unvaccinated Swedish children of the same birth cohort (4). Clinical and immunological studies did not support the hypothesis of an immunosuppressive effect of the vaccines, which would explain the deaths, but the hypothesis could not be refuted by the data. To evaluate the safety of acellular pertussis vaccines regarding rare severe events--in particular invasive infectious diseases--prospective studies seem to be needed, comparing very large groups. A coordinated and controlled vaccine programme during 1-2 years in most of Sweden combined with national reports of invasive infections may serve as a basis for such a study. A possible study design is given below.
Olin
P
P
Department of Paediatrics, Karolinska Institute, Sachs' Children's Hospital, Stockholm, Sweden.
Romanus
V
V
Storsaeter
J
J
D001424:Bacterial Infections / Q000453:epidemiology / Q000209:etiology* / Q000401:mortality; D002986:Clinical Trials as Topic; D006801:Humans; D007223:Infant; D010567:Pertussis Vaccine / Q000009:adverse effects* / Q000302:isolation & purification; D012307:Risk Factors; D013548:Sweden / Q000453:epidemiology
D010567:Pertussis Vaccine