Berhane Yemane, Worku Alemayehu, Demissie Meaza, Tesfaye Neghist, Asefa Nega, Aniemaw Worku, Weldearegawi Berhe, Kebede Yigzaw, Shiferaw Tigist, Worku Amare, Olijira Lemessa, Merdekios Behailu, Ashebir Yemane, Tadesse Takele, Dessie Yadeta, Meseret Solomon, Ayele Gestane
Addis Continental Institute of Public Health, Addis Ababa, Ethiopia.
Federal Ministry of Health, Addis Ababa, Ethiopia.
PLoS One. 2014 Jun 4;9(6):e97376. doi: 10.1371/journal.pone.0097376. eCollection 2014.
The single dose pneumonia ten-valent vaccine has been widely used and is highly efficacious against selected strains Streptococcus pneumonia. A two-dose vial without preservative is being introduced in developing countries to reduce the cost of the vaccine. In routine settings improper immunization practice could result in microbial contamination leading to adverse events following immunization.
To monitor adverse events following immunization recommended for routine administration during infancy by comparing the rate of injection-site abscess between children who received PCV-10 vaccine and children who received the Pentavalent (DPT-HepB-Hib) vaccine.
A longitudinal population-based multi-site observational study was conducted between September 2011 and October 2012. The study was conducted in four existing Health and Demographic Surveillance sites run by public universities of Abraminch, Haramaya, Gondar and Mekelle. Adverse events following Immunization were monitored by trained data collectors. Children were identified at the time of vaccination and followed at home at 48 hour and 7 day following immunization. Incidence of abscess and relative risk with the corresponding 95% Confidence Intervals were calculated to examine the risk difference in the comparison groups.
A total of 55, 268 PCV and 37, 480 Pentavalent (DPT-HepB-Hib) vaccinations were observed. A total of 19 adverse events following immunization, 10 abscesses and 9 deaths, were observed during the one year study period. The risk of developing abscess was not statistically different between children who received PCV-10 vaccine and those received Pentavalent (RR = 2.7, 95% CI 0.576-12.770), and between children who received the first aliquot of PCV and those received the second aliquot of PCV (RR = 1.72, 95% CI 0.485-6.091).
No significant increase in the risk of injection site abscess was observed between the injection sites of PCV-10 vaccine from a two-dose vial without preservative and pentavalent (DPT-HepB-Hib) vaccine in the first 7 days following vaccination.
单剂量肺炎十价疫苗已被广泛使用，对特定的肺炎链球菌菌株具有高度有效性。一种无防腐剂的两剂量小瓶疫苗正在发展中国家推出，以降低疫苗成本。在常规情况下，不当的免疫接种操作可能导致微生物污染，从而引发免疫接种后的不良事件。
通过比较接种10价肺炎球菌结合疫苗（PCV-10）的儿童和接种五联疫苗（白百破-乙肝- Hib）的儿童注射部位脓肿的发生率，监测婴儿期常规推荐免疫接种后的不良事件。
在2011年9月至2012年10月期间进行了一项基于人群的纵向多地点观察性研究。该研究在由阿布拉明奇、哈拉马亚、贡德尔和默克莱的公立大学运营的四个现有人口健康与人口监测点进行。由经过培训的数据收集者监测免疫接种后的不良事件。在接种疫苗时识别儿童，并在免疫接种后48小时和7天在家中进行随访。计算脓肿的发生率和相对风险以及相应的95%置信区间，以检查比较组中的风险差异。
共观察到55268剂PCV疫苗和37480剂五联疫苗（白百破-乙肝- Hib）接种。在一年的研究期间，共观察到19例免疫接种后不良事件，其中10例脓肿和9例死亡。接种PCV-10疫苗的儿童与接种五联疫苗的儿童发生脓肿的风险在统计学上无差异（RR = 2.7，95%CI 0.576 - 12.770），接种PCV第一剂的儿童与接种PCV第二剂的儿童之间也无差异（RR = 1.72，95%CI 0.485 - 6.091）。
在接种后前7天，来自无防腐剂两剂量小瓶的PCV-10疫苗注射部位与五联疫苗（白百破-乙肝- Hib）注射部位之间未观察到注射部位脓肿风险的显著增加。
