{"title":"[德国和印度生产的人用狂犬病疫苗(鸡胚胎细胞)的安全性和免疫原性]。","authors":"Feng-Cai Zhu, Chuan-Hong Wu, Fan-Yue Meng","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the safety and immunogenicity of Rabipur produced in India.</p><p><strong>Methods: </strong>A random and single-blind study was conducted to compare the safety, effect and sero conversion rates. Rabipur produced in Germany used as control group.</p><p><strong>Results: </strong>The results showed that they were no severe systemic and local reaction occurred in trial group (Rabipur produced in India). The difference between trial group and control group was not significant. 14 day and 45 days after the first dose, the seroconversion rates of the two groups were 100%. 14 day and 45 days after the first dose, GMC of the two groups increased obviously and highly beyond 0.5TU/ml.</p><p><strong>Conclusion: </strong>Rabipur produced in India has excellent safety and immunogenicity. Trial Registration National Food Drugs Surveillance Administrative Bureau, \"Medicine Clinical Experiment Written directive from a superior\" 2005L04184.</p>","PeriodicalId":56402,"journal":{"name":"中国疫苗和免疫","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2009-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Safety and immunogenicity of rabies vaccine (chick embryo cell) for human use produced in Germany and India].\",\"authors\":\"Feng-Cai Zhu, Chuan-Hong Wu, Fan-Yue Meng\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To evaluate the safety and immunogenicity of Rabipur produced in India.</p><p><strong>Methods: </strong>A random and single-blind study was conducted to compare the safety, effect and sero conversion rates. Rabipur produced in Germany used as control group.</p><p><strong>Results: </strong>The results showed that they were no severe systemic and local reaction occurred in trial group (Rabipur produced in India). The difference between trial group and control group was not significant. 14 day and 45 days after the first dose, the seroconversion rates of the two groups were 100%. 14 day and 45 days after the first dose, GMC of the two groups increased obviously and highly beyond 0.5TU/ml.</p><p><strong>Conclusion: </strong>Rabipur produced in India has excellent safety and immunogenicity. Trial Registration National Food Drugs Surveillance Administrative Bureau, \\\"Medicine Clinical Experiment Written directive from a superior\\\" 2005L04184.</p>\",\"PeriodicalId\":56402,\"journal\":{\"name\":\"中国疫苗和免疫\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2009-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"中国疫苗和免疫\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"中国疫苗和免疫","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
[Safety and immunogenicity of rabies vaccine (chick embryo cell) for human use produced in Germany and India].
Objective: To evaluate the safety and immunogenicity of Rabipur produced in India.
Methods: A random and single-blind study was conducted to compare the safety, effect and sero conversion rates. Rabipur produced in Germany used as control group.
Results: The results showed that they were no severe systemic and local reaction occurred in trial group (Rabipur produced in India). The difference between trial group and control group was not significant. 14 day and 45 days after the first dose, the seroconversion rates of the two groups were 100%. 14 day and 45 days after the first dose, GMC of the two groups increased obviously and highly beyond 0.5TU/ml.
Conclusion: Rabipur produced in India has excellent safety and immunogenicity. Trial Registration National Food Drugs Surveillance Administrative Bureau, "Medicine Clinical Experiment Written directive from a superior" 2005L04184.
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