[Translation] A randomized, blinded, parallel controlled phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (serum-free Vero cells) in different immunization schedules in people aged 10 to 60 years old
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。
[Translation] Main research objectives
1. To evaluate the non-inferiority of the immunogenicity of the 5-dose group of the test vaccine to the 5-dose group of the control vaccine;
2. To evaluate the non-inferiority of the immunogenicity of the 4-dose group of the test vaccine to the 5-dose group of the control vaccine.
Secondary objectives
1. To evaluate the immunogenicity of the 5-dose group of the test vaccine compared with the 5-dose group of the control vaccine;
2. To evaluate the immunogenicity of the 4-dose group of the test vaccine compared with the 5-dose group of the control vaccine;
3. To evaluate the immunogenicity of the 4-dose group of the test vaccine compared with the 5-dose group of the test vaccine;
4. To evaluate the immune persistence of the test vaccine;
5. To evaluate the safety of the test vaccine compared with the control vaccine.