[[[ Background: ]]] The diphtheria-tetanus-whole-cell pertussis (DTPw) vaccine is being replaced in Western countries,and in several Spanish Autonomous Communities, by the diphtheria-tetanus-acellular pertussis (DTPa) vaccine. Although the administration of booster doses of DTPw or DTPa and Haemophilus influenzae type b conjugate (Hib) vaccines to toddlers is a current practice ina number of countries, there are few data comparing the reactogenicity profiles of their administration as a single injection. [[[ Subjects and method: ]]] An open,prospective, randomised, multicentre trial was conducted to compare the reactogenicity profile of a single injection of DTPa and Hib vaccines (DTPa/Hib) with that of a single injection of DTPw and Hib vaccines (DTPw/Hib) as booster doses to toddlers–previously primed with DTPw and Hib vaccines. 200 children (15.1 +/-1.0 months-old) were randomised to receive DTPa/Hib (group 1;n = 101) or DTPw/Hib (group 2; n = 99) and followed up to 30 days post-vaccination. All subjects received the oral polio vaccine concomitantly. Local and general symptoms were recorded by parents on diary cards. [[[ Results: ]]] Incidences of any local reaction and any general symptom <<probably related>>/<<suspected>>to vaccination were reported more frequently in group 2 than in group 1 (p < 0.0001). Pain at the injection site was reported by 29% and 66% of subjects in groups 1 and 2, respectively (p< 0.0001). Pain such that the child cried when limb was moved was also more frequently recorded in group 2 (15%) than in group 1 (1%) (p < 0.0001). Differences in prevalence of any swelling(16% in group 1, 30% in group 2) and swelling > 20 mm reached statistical significance (p (3/4) 0.012). Fever (rectal temperature>= 38 degrees C) was reported by 17% and 41 % in groups 1 and 2 subjects, respectively (p < 0.0001). Fussiness, loss of appetite and restlessness were also more frequently reported in DTPw/Hib subjects and reached statistical significance (at least p = 0.015).Analgesics/antipyretics were prescribed as a prophylactic treatment in only 14% of cases (9 and 19 subjects in groups 1 and 2, respectively;p = 0.0424). Antipyretic treatment after vaccination was significantly more prescribed in group 2 (27 cases) than in group 1 (8) (p <0.015). [[[ Conclusion: ]]] The administration of DTPa/Hib as a single injection leads to a better reactogenicity profile than the administration of DTPw/Hib, also as a single injection, as booster doses to toddlers primed with DTPw and Hib vaccines.
Comparative trial to assess the reactogenicity of the diphtheria-tetanusacellular pertussis (DTPa) vaccine plus Haemophilus influenzae type b(Hib) conjugate vaccine and that of the diphtheria-tetanus-whole cell pertussis (DTPw) vaccine plus Hib conjugate vaccine, administered in single injection as a booster dose to 14-20 months-old children
디프테리아-파상풍-세포외 백일해(DTPa) 백신과 헤모필루스 인플루엔자 타입 b(Hib) 결합 백신의 반응성을 평가하기 위한 비교 시험과 디프테리아-파상풍-전체 세포 백일해(DTPw) 백신과 Hib 결합 백신의 반응성을 평가하기 위한 비교 시험으로, 14-20개월 된 어린이에게 단일 주사로 부스터 접종으로 시행됨.
[Category] 백일해, 파상풍,
[Article Type] journal-article
[Source] pubmed
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