2
项与 冻干人狂犬病疫苗(宁波荣安生物药业有限公司) 相关的临床试验评价冻干人用狂犬病疫苗(无血清Vero细胞)以不同免疫程序接种于10~60周岁人群的免疫原性和安全性的随机、盲法、同类疫苗平行对照III期临床试验
主要研究目的
1.评价试验疫苗5剂组免疫原性非劣效于对照疫苗5剂组;
2.评价试验疫苗4剂组免疫原性非劣效于对照疫苗5剂组。
次要目的
1.评价试验疫苗5剂组相比于对照疫苗5剂组的免疫原性;
2.评价试验疫苗4剂组相比于对照疫苗5剂组的免疫原性;
3.评价试验疫苗4剂组相比于试验疫苗5剂组的免疫原性;
4.评价试验疫苗的免疫持久性;
5.评价试验疫苗相比于对照疫苗的安全性。
A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Without Serum Vero Cells) Administered to People Aged 10-60 Years With Different Immunization Procedures
This study was intended to explore the safety and immunogenicity of the test vaccine compared to the control vaccine. The trial consisted of two phases.
Phase I used an open-ended design. Phase II used a randomized, blinded, parallel-controlled non-inferiority design with the same type of active vaccine, in which the control vaccine 5-dose group and the test vaccine 5 group were kept blinded throughout, the test vaccine 4-dose B group was kept blinded from the other three groups until visit 4 (D14), and the test vaccine 4-dose A group was kept blinded from the control vaccine 5-dose group and the test vaccine 5-dose group until visit 5 (D28).
100 项与 冻干人狂犬病疫苗(宁波荣安生物药业有限公司) 相关的临床结果
100 项与 冻干人狂犬病疫苗(宁波荣安生物药业有限公司) 相关的转化医学
100 项与 冻干人狂犬病疫苗(宁波荣安生物药业有限公司) 相关的专利(医药)
100 项与 冻干人狂犬病疫苗(宁波荣安生物药业有限公司) 相关的药物交易