[Translation] An open-label observation of a bivalent inactivated enterovirus vaccine (Vero cells) in healthy adults and children aged 6 to 12 years, and a randomized, double-blind, controlled phase I/II clinical trial to evaluate the tolerability, safety and immunogenicity of the vaccine in children aged 6 to 71 months
Ⅰ期临床试验:
主要目的:基于不良事件,评价试验疫苗在不同年龄组参与者中的安全性。
次要目的:1.基于不良事件,评价试验疫苗在不同年龄组参与者中的安全性;2.基于实验室指标异常情况,评价试验疫苗在不同年龄组参与者中的安全性。 Ⅱ期临床试验:
主要目的:评价试验疫苗其他免疫原性指标。
次要目的:1.基于不良事件,评价试验疫苗的安全性;2.评价试验疫苗的免疫持久性。
[Translation] Phase I clinical trial:
Main purpose: To evaluate the safety of the trial vaccine in participants of different age groups based on adverse events.
Secondary purpose: 1. To evaluate the safety of the trial vaccine in participants of different age groups based on adverse events; 2. To evaluate the safety of the trial vaccine in participants of different age groups based on abnormal laboratory indicators. Phase II clinical trial:
Main purpose: To evaluate other immunogenicity indicators of the trial vaccine.
Secondary purpose: 1. To evaluate the safety of the trial vaccine based on adverse events; 2. To evaluate the immune persistence of the trial vaccine.