Immunogenicity and safety of combined adsorbed low-dose diphtheria, tetanus and inactivated poliovirus vaccine (REVAXIS®) versus combined diphtheria, tetanus and inactivated poliovirus vaccine (DT Polio®) given as a booster dose at 6 years of age
Immunogenicity and safety of combined adsorbed low-dose diphtheria, tetanus and inactivated poliovirus vaccine (REVAXIS®) versus combined diphtheria, tetanus and inactivated poliovirus vaccine (DT Polio®) given as a booster dose at 6 years of age
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DOI：
10.4161/hv.7.5.14982
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发表时间：
2011-05-01
期刊：
影响因子：
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通讯作者：
Fiquet, Anne
中科院分区：
文献类型：
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作者：
Gajdos, Vincent;Soubeyrand, Benoit;Fiquet, Anne
这项在法国进行的随机、比较、IIIb期研究旨在证明REVAXIS（低剂量白喉）单次给药后1个月对白喉、破伤风和脊髓灰质炎的血清保护是否不劣于DT Polio（标准剂量白喉）单次给药后1个月的血清保护，两种疫苗均作为6岁健康儿童的第二次加强接种。儿童被随机分配接受单次肌肉注射REVAXIS或DT脊髓灰质炎。主要终点是白喉、破伤风和脊髓灰质炎病毒1型、2型和3型抗原的加强免疫后1个月血清保护率。次要终点为免疫原性和安全性观察结果。在接受筛查的788名儿童中，760名儿童被随机分组：REVAXIS组，384名儿童; DT脊髓灰质炎组，376名儿童。在REVAXIS和DT脊髓灰质炎组之间未观察到基线人口统计学特征的相关差异。证明了REVAXIS与DT Polio相比在白喉（分别为98.6%和99.3%）、破伤风（分别为99.6%和100%）和脊髓灰质炎病毒抗原（两组中每种类型均为100%）血清保护方面的非劣效性。未报告对REVAXIS的过敏反应。与DT Polio相比，REVAXIS在重度征集性注射部位反应发生率方面的耐受性更好的趋势表明了有利于REVAXIS的获益/风险比。这些结果支持在出生后6个月内接受过3剂初级系列疫苗和2岁前接受过包括白喉、破伤风和脊髓灰质炎病毒疫苗在内的首次加强疫苗的婴儿中，在6岁时使用REVAXIS作为加强疫苗。
This randomized, comparative, phase-IIIb study conducted in France aimed to demonstrate whether seroprotection against diphtheria, tetanus and poliomyelitis 1 month after a single dose of REVAXIS (low-dose diphtheria) is non-inferior to seroprotection 1 month after a single dose of DT Polio (standard-dose diphtheria), both vaccines being given as a second booster to healthy children at 6 years of age. Children were randomly assigned to receive a single intramuscular dose of REVAXIS or DT Polio. Primary endpoints were the 1-month post-booster seroprotection rates for diphtheria, tetanus and poliovirus type-1, -2 and -3 antigens. Secondary endpoints were immunogenicity and safety observations. Of 788 children screened, 760 were randomized: REVAXIS group, 384 children; DT Polio group, 376 children. No relevant difference in demographic characteristics at baseline was observed between REVAXIS and DT Polio groups. Non-inferiority of REVAXIS compared with DT Polio for seroprotection was demonstrated against diphtheria (respectively 98.6% and 99.3%), tetanus (respectively 99.6% and 100%) and poliovirus antigens (100% for each types in both groups). No allergic reactions to REVAXIS were reported. A benefit/risk ratio in favor of REVAXIS was suggested by the trend towards a better tolerability of REVAXIS compared with DT Polio regarding the rate of severe solicited injection-site reactions. The results support the use of REVAXIS as a booster at 6 years of age in infants who previously received a three-dose primary series within the first 6 months of life and a first booster including diphtheria, tetanus and poliovirus vaccine(s) given before 2 years of age.