Knuf M, Habermehl P, Cimino C, Petersen G, Schmitt H-J
Pediatric Infectious Disease, Johannes Gutenberg University, Langenbeckstr. 1, D-55101 Mainz, Germany.
Vaccine. 2006 May 29;24(22):4727-36. doi: 10.1016/j.vaccine.2006.03.032. Epub 2006 Mar 24.
To evaluate immunogenicity, reactogenicity, and safety of a hexavalent combination vaccine diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) when coadministered with a 7-valent pneumococcal conjugate vaccine (PCV7).
Infants received either a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio virus-H. influenzae type b vaccine concomitantly with PCV7 or DTPa-HBV-IPV/Hib alone infants were vaccinated at 2, 3 and 4 months (primary immunization) and 12-15 months of age (booster dose). Local and systemic reactions and adverse events were monitored following each dose and compared between groups. Blood was obtained prior to dose 1, one month after dose 3, immediately prior to and 1 month following the booster dose to measure antibody responses to each of the antigens.
Two hundred and fifty-three subjects (PCV7, 127; Control, 126) were enrolled. Antibody responses were compared in 226 subjects for the primary immunization and 212 for the booster dose (per-protocol (PP) population). Although there were some differences in geometric mean concentrations (GMCs) to the DTPa-HBV-IPV/Hib antigens after the primary series, GMCs for all antigens after the booster dose were similar in both groups, except for diphtheria which was significantly higher in the PCV7 group (PCV7, 7.41 IU/mL; Control, 5.78 IU/mL). Reactogenicity and safety data were compared in 252 infants receiving primary immunization and 235 children receiving the booster dose. Site reactions were similar in both groups. Fever >or=38.0 degrees C following each vaccination was reported more frequently in the PCV7 group (28.3-50.0%) than in the Control group (15.6-33.6%) whereas fever >39.0 degrees C occurred only in a few cases and to the same extent in both groups (PCV7, 0.8-2.7%; Control, 1.6-4.1%). Only one reported serious adverse event was characterized as being related to the study vaccines: control subject was hospitalized with a fever.
DTPa-HBV-IPV/Hib and PCV7 were highly immunogenic, well-tolerated and safe when coadministered at 2, 3 and 4 months of age with a booster dose at 12-15 months of age. These results support the coadministration of PVC7 with DTPa-HBV-IPV/Hib as part of the routine immunization schedule for infants and children.
评估六价联合疫苗白喉-破伤风-无细胞百日咳-乙型肝炎-灭活脊髓灰质炎病毒- b型流感嗜血杆菌（DTPa-HBV-IPV/Hib）与七价肺炎球菌结合疫苗（PCV7）同时接种时的免疫原性、反应原性和安全性。
婴儿在2、3和4个月龄（基础免疫）以及12 - 15个月龄（加强剂量）时，接受DTPa-HBV-IPV/Hib与PCV7同时接种，或仅接种DTPa-HBV-IPV/Hib。每次接种后监测局部和全身反应及不良事件，并在组间进行比较。在第1剂接种前、第3剂接种后1个月、加强剂量接种前即刻以及接种后1个月采集血液，以测量对每种抗原的抗体反应。
共纳入253名受试者（PCV7组127名；对照组126名）。对226名受试者的基础免疫和212名受试者的加强剂量（符合方案（PP）人群）进行了抗体反应比较。虽然基础免疫系列后对DTPa-HBV-IPV/Hib抗原的几何平均浓度（GMC）存在一些差异，但加强剂量后两组所有抗原的GMC相似，除了白喉，PCV7组的GMC显著更高（PCV7组为7.41 IU/mL；对照组为5.78 IU/mL）。对252名接受基础免疫的婴儿和235名接受加强剂量的儿童的反应原性和安全性数据进行了比较。两组的局部反应相似。PCV7组每次接种后体温≥38.0℃的报告频率高于对照组（28.3 - 50.0%比15.6 - 33.6%），而体温>39.0℃仅在少数情况下出现，且两组程度相同（PCV7组为0.8 - 2.7%；对照组为1.6 - 4.1%）。仅1例报告的严重不良事件被判定与研究疫苗有关：1名对照受试者因发热住院。
DTPa-HBV-IPV/Hib与PCV7在2、3和4个月龄同时接种，并在12 - 15个月龄进行加强剂量接种时，具有高度免疫原性、耐受性良好且安全。这些结果支持将PCV7与DTPa-HBV-IPV/Hib同时接种作为婴幼儿常规免疫计划的一部分。
