[口服脊髓灰质炎减毒活疫苗(人二倍体细胞)安全性和免疫原性研究]。

中国疫苗和免疫 Pub Date : 2010-06-01
Shao-Hong Guo, Hong Tao, Zhi-fang Ying
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引用次数: 0

摘要

目的:评价小儿麻痹症疫苗(人二倍体细胞疫苗)在>或=2月龄儿童中的安全性和免疫原性。方法:对江苏省1200例2 ~ 5月龄健康儿童进行随机、盲、对照试验,分别接种OPV (HDC)疫苗和对照疫苗。中和试验检测抗体。结果:接种3剂OPV (HDC)疫苗后,全身反应轻微。接种3剂OPV (HDC)疫苗1个月后,ⅰ、ⅱ、ⅲ型的免疫成功率分别为98.28%、99.45%和95.71%,易感儿童ⅰ、ⅱ、ⅲ型的GMTs分别为1:12 . 43.72、1:23 .38和1:27 . 3.10。结论:OPV (HDC)疫苗对≥2月龄儿童安全,具有免疫原性。
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[Study on safety and immunogenicity of oral poliomyelitis attenuated live vaccine (human diploid cell)].

Objective: To evaluate the safety and Immunogenicity of the Poliomyelitis vaccine (Human Diploid Cell) in > or =2 month-old children.

Methods: A random, blind and control trial, 1200 healthy children of 2-5 months old in Jiangsu province were administered OPV (HDC) vaccine and control vaccines. The antibody was tested by neutralization test.

Results: After 3 doses of the OPV (HDC) vaccine, the systemic reactions were mild. After 1 month of vaccination with 3 doses of the OPV (HDC) vaccine, the immune success rates of I, II, III type were 98.28%, 99.45%, and 95.71% respectively, the GMTs of I, II, III type in susceptible children were 1:1243.72, 1:234.38 and 1:273.10 respectively.

Conclusions: The OPV (HDC) vaccine was safe and immunogenicity for the children > or =2 months old.

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