Marshall H, Nolan T, Roberton D, Richmond P, Lambert S, Jacquet J M, Schuerman L
Department of Paediatrics, Children's Youth and Women's Health Service and University of Adelaide, SA, Australia.
Vaccine. 2006 Aug 28;24(35-36):6120-8. doi: 10.1016/j.vaccine.2006.05.017. Epub 2006 Jun 2.
This study evaluated GSK's combined DTPa-IPV vaccine (Infanrix-IPV) given as a fifth consecutive acellular pertussis booster dose in conjunction with the second dose of MMR vaccine (Priorix) in children aged 4-6 years. The immunogenicity and reactogenicity of this vaccine regimen was compared with separate injections of DTPa and IPV when given concomitantly with MMR. A cohort of 362 children previously primed with four doses of DTPa and OPV, and a single dose of MMR were randomized to receive either DTPa-IPV+MMR (N=181) or DTPa+IPV+MMR (N=181). Antibody concentrations were measured prior to and 1 month after the booster dose. After immunisation all subjects from both groups had seroprotective antibody levels against diphtheria, tetanus and the three poliovirus serotypes, > or = 96% showed vaccine response to PT, FHA and PRN, all were seropositive to mumps and rubella, and all but one subject were seropositive to measles. Immunogenicity results for each component antigen were similar for DTPa-IPV and separately co-administered DTPa and IPV. Local reactions were common with 24.0% and 31.1% of children experiencing swelling >50mm at the DTPa-IPV and DTPa injection sites, respectively. The DTPa-IPV combination did not increase the incidence or intensity of adverse events compared with separately administered DTPa+IPV. The response to the concomitantly administered MMR vaccine was similar in the two groups and similar to previously reported responses for a second dose of MMR. This combined DTPa-IPV vaccine has a similar reactogenicity profile to DTPa, is immunogenic when given as a booster dose at 4-6 years of age, and has no impact on the immunogenicity of a co-administered second dose of MMR vaccine.
本研究评估了葛兰素史克公司的联合疫苗白喉破伤风无细胞百日咳-灭活脊髓灰质炎疫苗（Infanrix-IPV），在4至6岁儿童中作为连续第五剂无细胞百日咳加强疫苗与第二剂麻腮风疫苗（Priorix）同时接种的情况。将该疫苗接种方案的免疫原性和反应原性与白喉破伤风无细胞百日咳疫苗和灭活脊髓灰质炎疫苗分别与麻腮风疫苗同时接种时的情况进行了比较。一组362名先前已接种四剂白喉破伤风无细胞百日咳疫苗和口服脊髓灰质炎疫苗以及一剂麻腮风疫苗的儿童被随机分为两组，分别接受白喉破伤风无细胞百日咳-灭活脊髓灰质炎疫苗+麻腮风疫苗（N = 181）或白喉破伤风无细胞百日咳疫苗+灭活脊髓灰质炎疫苗+麻腮风疫苗（N = 181）。在加强剂量接种前和接种后1个月测量抗体浓度。免疫后，两组所有受试者对白喉、破伤风和三种脊髓灰质炎病毒血清型均具有血清保护性抗体水平，≥96%的受试者对百日咳毒素、丝状血凝素和百日咳杆菌黏附素显示出疫苗反应，所有受试者对腮腺炎和风疹均为血清阳性，除一名受试者外，所有受试者对麻疹均为血清阳性。白喉破伤风无细胞百日咳-灭活脊髓灰质炎疫苗与分别联合接种的白喉破伤风无细胞百日咳疫苗和灭活脊髓灰质炎疫苗相比，各组分抗原的免疫原性结果相似。局部反应较为常见，分别有24.0%和31.1%的儿童在白喉破伤风无细胞百日咳-灭活脊髓灰质炎疫苗和白喉破伤风无细胞百日咳疫苗接种部位出现肿胀>50mm。与分别接种白喉破伤风无细胞百日咳疫苗+灭活脊髓灰质炎疫苗相比，白喉破伤风无细胞百日咳-灭活脊髓灰质炎联合疫苗并未增加不良事件的发生率或严重程度。两组对同时接种的麻腮风疫苗的反应相似，且与先前报道的第二剂麻腮风疫苗的反应相似。这种联合白喉破伤风无细胞百日咳-灭活脊髓灰质炎疫苗的反应原性特征与白喉破伤风无细胞百日咳疫苗相似，在4至6岁作为加强剂量接种时具有免疫原性，且对同时接种的第二剂麻腮风疫苗的免疫原性无影响。
