Target- |
MechanismImmunostimulants |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date22 Nov 2006 |
随机化盲法在10-50岁健康人群中接种迈丰冻干人用狂犬病疫苗(Vero细胞)与同类制品进行安全性和免疫原性比较
[Translation] Comparison of safety and immunogenicity of Maifeng freeze-dried human rabies vaccine (Vero cells) and similar products in healthy people aged 10-50 years by randomized blind method
试验疫苗全程接种后14天,试验疫苗组的抗体阳转率达到100%;试验疫苗抗体阳转率非劣效于对照组疫苗。 比较首剂接种后14天以及全程接种后14天试验疫苗组和对照疫苗组的狂犬病毒中和抗体几何平均浓度(GMC);所有受试者均详细观察首剂接种后至全程接种后30天内以及全程接种后6个月内所发生的不良事件。
[Translation] 14 days after the whole inoculation of the experimental vaccine, the antibody positive conversion rate of the experimental vaccine group reached 100%; the antibody positive conversion rate of the experimental vaccine was non-inferior to the control group vaccine. The geometric mean concentrations (GMC) of rabies virus neutralizing antibodies in the experimental vaccine group and the control vaccine group were compared 14 days after the first dose of inoculation and 14 days after the full inoculation; all subjects were observed in detail from the first dose to 30 days after the full inoculation and adverse events that occurred within 6 months of full vaccination.
100 Clinical Results associated with Jilin Mai Fung Bio-Pharmaceutical Co Ltd
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