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首页> 外文期刊>BMC Pediatrics >The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule
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The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule

机译：印尼DTP-HB-Hib联合疫苗扩大免疫计划的免疫原性，安全性和一致性

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WHO recommended incorporation of Haemophilus influenzae type b (Hib) vaccination into immunization program. Indonesia would adopt Hib as a National Immunization Program in 2013. We aimed at analyzing immunogenicity, safety, and consistency of a new combined DTP-HB-Hib (diphtheria-tetanus-pertussis-Hepatitis B-Haemophilus influenza B) vaccine. A prospective, randomized, double blind, multicenter, phase III study of Bio Farma DTP-HB-Hib vaccine conducted in Jakarta and Bandung, August 2012 - January 2013. Subjects were divided into three groups with different batch number. Healthy infants 6–11 weeks of age at enrollment were immunized with 3 doses of DTP-HB-Hib vaccine with interval of 4?weeks, after birth dose of hepatitis B vaccine. Blood samples obtained prior to vaccination and 28?days after the third dose. Safety measures recorded until 28?days after each dose. Of 600 subjects, 575 (96?%) completed study protocol. After 3 doses, 100.0 and 96.0?% had anti-PRP concentration ≥0.15 and ≥1.0?μg/ml. Anti-diphtheria and anti-tetanus concentration ≥0.01?IU/ml detected in 99.7 and 100.0?%; while concentration ≥0.1?IU/ml achieved in 84.0 and 97.4?%. Protective anti-HBs found in 99.3?%. The pertussis vaccine response rate was 84.9?%. None Serious Adverse events (SAEs) considered related to study vaccine or procedure. The 3-dose of DTP-HB-Hib was immunogenic, well tolerated and suitable for replacement of licensed-equivalent vaccines based on immunologic and safety profiles. NCT01986335 – October 30th 2013.
机译：世卫组织建议将乙型流感嗜血杆菌（Hib）疫苗接种纳入免疫规划。印度尼西亚将于2013年将Hib纳入国家免疫计划。我们旨在分析新型DTP-HB-Hib（白喉-破伤风-百日咳-乙型肝炎-乙型流感嗜血杆菌）联合疫苗的免疫原性，安全性和一致性。 2012年8月至2013年1月在雅加达和万隆进行了一项关于Bio Farma DTP-HB-Hib疫苗的前瞻性，随机，双盲，多中心III期研究。受试者分为三组，每组具有不同的批号。在出生后接种乙肝疫苗后，应在6-11周龄的健康婴儿中接种3剂DTP-HB-Hib疫苗，间隔为4周。疫苗接种前和第三剂接种后28天采集的血样。记录安全措施，直到每次给药后28天。在600名受试者中，有575名（96％）完成了研究方案。 3次给药后，抗PRP浓度分别为100.0和96.0％，≥0.15和≥1.0？g / ml。检出抗白喉和破伤风的浓度≥0.01？IU / ml，分别为99.7和100.0？％;浓度≥0.1？IU / ml达到84.0和97.4？％。保护性抗-HBs占99.3％。百日咳疫苗反应率为84.9％。无严重不良事件（SAE）被认为与研究疫苗或程序有关。 DTP-HB-Hib的3剂量具有免疫原性，耐受性强，适合根据免疫学和安全性概况替代许可的等效疫苗。 NCT01986335 – 2013年10月30日。

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