Rothstein E P, Bernstein H H, Glode M P, Laussucq S, Nonenmacher J, Long S S, Hackell J G
Temple University School of Medicine, Philadelphia, Pa.
Am J Dis Child. 1993 Aug;147(8):854-7. doi: 10.1001/archpedi.1993.02160320056019.
To compare the safety and immunogenicity of Lederle Laboratories' (Pearl River, NY) diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine with diphtheria and tetanus toxoids and whole-cell pertussis (DTwP) vaccine when administered simultaneously with measles-mumps-rubella (MMR) vaccine and trivalent oral poliovirus (OPV) vaccine at 15 to 16 months of age.
Randomized and double-blind.
Two general pediatric practices.
Ninety-seven infants, aged 15 to 16 months, who had received three previous DTwP immunizations. SELECTION PROCEDURES AND INTERVENTIONS: Healthy children received the DTaP or DTwP vaccine. Infants received the MMR vaccine at a separate site and the OPV vaccine concurrently. Blood was obtained on day 0 and at 6 weeks. Adverse events were recorded by parents at specified times after immunization.
MEASUREMENTS/RESULTS: Within 3 days of immunization, DTaP vaccine recipients had less fever, drowsiness, and irritability (P = .01, .04, .01, respectively). They also experienced less tenderness, erythema, and induration (.001, .001, and .002, respectively). There was no difference in the frequency of adverse reactions 6 to 14 days after immunization. Enzyme-linked immunosorbent assays were used to determine all antibody values. Antibody responses to filamentous hemagglutinin and pertussis toxoid were significantly greater in the DTaP group (P = .0001 and .02, respectively). Immune responses to the other measured antigens were similar.
Simultaneous administration of the Lederle DTaP with MMR and OPV vaccines did not interfere with antibody response to pertussis antigens measured or measles, mumps, or rubella viruses and was associated with fewer local and systemic adverse events during the first 3 days following immunization when compared with the simultaneous administration of the DTwP, OPV, and MMR vaccines. We conclude that the DTaP vaccine can be administered at 15 months of age concurrently with the MMR and OPV vaccines.
比较莱德利实验室（纽约州珍珠河）生产的白喉破伤风类毒素及无细胞百日咳疫苗（DTaP）与白喉破伤风类毒素及全细胞百日咳疫苗（DTwP）在15至16月龄时与麻疹-腮腺炎-风疹疫苗（MMR）及三价口服脊髓灰质炎疫苗（OPV）同时接种时的安全性和免疫原性。
随机双盲。
两家普通儿科诊所。
97名15至16月龄的婴儿，此前已接种过3剂DTwP疫苗。选择程序和干预措施：健康儿童接种DTaP或DTwP疫苗。婴儿在不同部位接种MMR疫苗，同时接种OPV疫苗。在第0天和6周时采集血液。父母在免疫接种后的特定时间记录不良事件。
测量指标/结果：免疫接种后3天内，DTaP疫苗接种者发热、嗜睡和易激惹的情况较少（P值分别为0.01、0.04、0.01）。他们出现压痛、红斑和硬结的情况也较少（P值分别为0.001、0.001和0.002）。免疫接种后6至14天不良反应的发生率没有差异。采用酶联免疫吸附测定法测定所有抗体值。DTaP组对丝状血凝素和百日咳毒素的抗体反应明显更强（P值分别为0.0001和0.02）。对其他检测抗原的免疫反应相似。
与同时接种DTwP、OPV和MMR疫苗相比，莱德利DTaP疫苗与MMR和OPV疫苗同时接种不会干扰对所测百日咳抗原或麻疹、腮腺炎或风疹病毒的抗体反应，且在免疫接种后的前3天与较少的局部和全身不良事件相关。我们得出结论，DTaP疫苗可在15月龄时与MMR和OPV疫苗同时接种。
