Anh Dang Duc, Jayadeva Girish, Kuriyakose Sherine, Han Htay Htay
National Institute of Hygiene and Epidemiology, 1 Yersin, Hanoi 1000, Vietnam.
GSK Pharmaceuticals India Ltd., Bangalore, India.
Vaccine. 2016 Aug 17;34(37):4360-3. doi: 10.1016/j.vaccine.2016.07.005. Epub 2016 Jul 16.
Despite effective infant immunization against pertussis, the disease continues to circulate due to waning immunity. Booster vaccinations against pertussis beyond infancy are widely recommended. In Vietnam, however, no recommendations for pertussis boosters beyond the second year of life exist. This open-label, single-centre study was designed to assess the safety of a single booster dose of reduced-antigen-content-diphtheria-tetanus-acellular-pertussis vaccine (dTpa) in 300 healthy Vietnamese children (mean age 7.9years), who had completed primary vaccination against diphtheria, tetanus and pertussis. Solicited symptoms were recorded for 4days and unsolicited and serious adverse events (SAEs) for 31days post-vaccination. Pain and fatigue were the most common solicited local and general symptoms in 35.0% and 14.0% of children, respectively. Grade 3 swelling occurred in 3 children; no large injection site reactions or SAEs were reported. The dTpa booster vaccine was well tolerated and this study supports its administration in school age Vietnamese children.
尽管对婴儿进行了有效的百日咳免疫接种，但由于免疫力下降，该疾病仍在传播。广泛建议在婴儿期之后进行百日咳加强疫苗接种。然而，在越南，不存在关于两岁以后百日咳加强疫苗接种的建议。这项开放标签的单中心研究旨在评估300名健康越南儿童（平均年龄7.9岁）接种一剂低抗原含量白喉-破伤风-无细胞百日咳疫苗（dTpa）加强针的安全性，这些儿童已完成白喉、破伤风和百日咳的基础疫苗接种。在接种疫苗后4天记录主动报告的症状，31天记录非主动报告的严重不良事件（SAEs）。疼痛和疲劳分别是35.0%和14.0%儿童中最常见的主动报告的局部和全身症状。3名儿童出现3级肿胀；未报告大型注射部位反应或严重不良事件。dTpa加强疫苗耐受性良好，本研究支持在学龄期越南儿童中接种该疫苗。
