Zhongguo yi miao he mian yi · 2009
[Safety and immunogenicity of rabies vaccine (chick embryo cell) for human use produced in Germany and India].
Аннотация на английскомСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Zhu Feng-Cai, Wu Chuan-Hong, Meng Fan-Yue
Аннотация
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.
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.