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首页> 外文期刊>Vaccine >Immunogenicity, reactogenicity and safety of a 7-valent pneumococcal conjugate vaccine (PCV7) concurrently administered with a DTPa-HBV-IPV/Hib combination vaccine in healthy infants
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Immunogenicity, reactogenicity and safety of a 7-valent pneumococcal conjugate vaccine (PCV7) concurrently administered with a DTPa-HBV-IPV/Hib combination vaccine in healthy infants

机译：7价肺炎球菌结合疫苗（DTV-HBV-IPV / Hib组合疫苗）的7价肺炎球菌结合疫苗的免疫原性，反应原性和安全性

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BACKGROUND: 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). METHODS: 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. RESULTS: 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. CONCLUSION: 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.
机译：背景：评价六价组合疫苗白喉-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）的免疫原性，反应原性和安全性结合疫苗（PCV7）。方法：婴儿接受六价白喉-破伤风-无细胞百日咳-乙型肝炎灭活的脊髓灰质炎病毒-H。 b型流感疫苗与PCV7或DTPa-HBV-IPV / Hib单独接种，分别在2、3、4个月（初次免疫）和12-15个月大时（加强剂量）接种疫苗。每次给药后监测局部和全身反应以及不良反应，并在各组之间进行比较。在剂量1之前，在剂量3之后一个月，紧接加强剂量之前和之后以及1个月后采集血液，以测量对每种抗原的抗体反应。结果：253名受试者（PCV7，127;对照，126）入组。比较了226位受试者的初次免疫和212位加强剂量（按方案（PP）人群）的抗体反应。尽管在一次系列试验后，与DTPa-HBV-IPV / Hib抗原的几何平均浓度（GMC）存在一些差异，但两组中加强剂量后所有抗原的GMC相似，除了白喉明显高于对照组。 PCV7组（PCV7，7.41 IU / mL;对照组，5.78 IU / mL）。在252名接受初次免疫的婴儿和235名接受加强剂量的儿童中比较了反应原性和安全性数据。两组的部位反应相似。据报道，PCV7组（28.3-50.0％）的每次疫苗接种后发烧≥38.0℃（13.6％-33.6％），而对照组中发烧> 39.0℃的情况仅在少数情况下发生。两组的感染程度相同（PCV7，0.8-2.7％;对照组，1.6-4.1％）。只有一个报告的严重不良事件被表征为与研究疫苗有关：对照组被发烧住院。结论：DTPa-HBV-IPV / Hib和PCV7在2、3和4个月大时联合使用，并在12-15个月大时加强剂量，具有很高的免疫原性，耐受性和安全性。这些结果支持将PVC7与DTPa-HBV-IPV / Hib共同给药，作为婴儿和儿童常规免疫计划的一部分。

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