[Translation] A phase I clinical trial to evaluate the safety, tolerability, and preliminary immunogenicity of the EV71-CA16 bivalent inactivated hand, foot, and mouth disease vaccine (human diploid cells) in healthy Chinese subjects aged 6 months to 11 years and 18 to 49 years.
主要目的:
评价EV71-CA16二价手足口病灭活疫苗(人二倍体细胞)在6月龄~11周岁和18~49周岁健康人群中接种的安全性和耐受性。
次要目的:
1)评价EV71-CA16二价手足口病灭活疫苗(人二倍体细胞)在6月龄~11周岁和18~49周岁健康人群中接种的长期安全性;
2)初步探索EV71-CA16二价手足口病灭活疫苗(人二倍体细胞)的免疫原性。
[Translation] Primary Objective:
To evaluate the safety and tolerability of the bivalent EV71-CA16 inactivated hand, foot and mouth disease vaccine (human diploid cells) in healthy individuals aged 6 months to 11 years and 18 to 49 years.
Secondary Objectives:
1) To evaluate the long-term safety of the bivalent EV71-CA16 inactivated hand, foot and mouth disease vaccine (human diploid cells) in healthy individuals aged 6 months to 11 years and 18 to 49 years;
2) To preliminarily investigate the immunogenicity of the bivalent EV71-CA16 inactivated hand, foot and mouth disease vaccine (human diploid cells).