Jiangsu Zhonghui Yuantong Biological Technology Co., Ltd.

The safety of different immunization procedures of rabies vaccine (human diploid cells) was investigated by successive design of different age groups. The two vaccination procedures were carried out successively according to the age of the subjects from the oldest to the youngest. The first 40 subjects aged 18-60 were randomly assigned to the Essen experimental group and the Zagreb experimental group in a 1:1 ratio, all of whom received the experimental vaccine. After the observation of the third dose of vaccine for at least 7 days, the preliminary safety assessment was conducted. If the incidence of grade 3 or higher adverse events associated with the experimental vaccination did not exceed 15%, and no vaccination-related death or life-threatening serious adverse events occurred, 40 subjects aged 10-17 years old were enrolled, and 40 subjects aged 10-17 years old were randomly assigned to the Essen and Zagreb trials in a 1:1 ratio. Conduct safety studies.
Safety study: All adverse events that occurred within 30 minutes, 0-7 days, and 0-30 days after each dose were collected, as well as all serious adverse events that occurred within 6 months after the first dose. Blood and urine samples were collected before the first dose and 3 days after the first dose, and blood routine, blood biochemical and urine routine tests were performed for safety assessment.

评价试验疫苗 Essen 程序和 Zagreb 程序的安全性。

主要目的：评价0.5ml/支四价流感病毒亚单位疫苗在6-35月龄健康人群中接种后的安全性和免疫原性。次要目的：评价0.25ml/支四价流感病毒亚单位疫苗在6-35月龄健康人群中接种后的安全性和免疫原性。探索性目的：1.比较 0.5ml/支与 0.25ml/支四价流感病毒亚单位疫苗在 6-35 月龄健康人群中接种后的安全性和免疫原性的差异；2.探索 0.5ml/支与 0.25ml/支四价流感病毒亚单位疫苗在 6-35 月龄健康人群中全程接种后的 3 个月和 6 个月免疫持久性。