[Translation] A randomized, blinded, positive vaccine-controlled phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (human diploid cells) in healthy subjects at different immunization schedules
主要目的:
评价试验疫苗(冻干人用狂犬病疫苗(人二倍体细胞))接种于10周岁及以上健康人群后的免疫原性非劣效于阳性对照疫苗。
次要目的:
1) 评价冻干人用狂犬病疫苗(人二倍体细胞)在10周岁及以上健康人群中的安全性。
2) 评价冻干人用狂犬病疫苗(人二倍体细胞)在10周岁及以上健康人群中的免疫持久性。
[Translation] Primary objective:
To evaluate the immunogenicity of the experimental vaccine (freeze-dried human rabies vaccine (human diploid cells)) in healthy people aged 10 years and above, and to determine whether it is non-inferior to the positive control vaccine.
Secondary objectives:
1) To evaluate the safety of freeze-dried human rabies vaccine (human diploid cells) in healthy people aged 10 years and above.
2) To evaluate the immune persistence of freeze-dried human rabies vaccine (human diploid cells) in healthy people aged 10 years and above.