Target- |
MechanismImmunostimulants |
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|
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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] A randomized, blinded comparison of the safety and immunogenicity of Maifeng freeze-dried human rabies vaccine (Vero cells) and similar products in healthy people aged 10-50 years
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 full course of the test vaccine, the antibody conversion rate of the test vaccine group reached 100%; the antibody conversion rate of the test vaccine was non-inferior to that of the control vaccine. The geometric mean concentration (GMC) of rabies virus neutralizing antibodies in the test vaccine group and the control vaccine group was compared 14 days after the first dose and 14 days after the full course of vaccination; all subjects were observed in detail for adverse events that occurred within 30 days after the first dose and within 6 months after the full course of vaccination.
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