[Translation] A single-center, randomized, blinded, placebo-controlled phase I/II clinical trial evaluating the safety, tolerability, and immunogenicity of a recombinant respiratory syncytial virus vaccine (CHO cells) in individuals aged 18 years and older.
Ⅰ期试验目的 主要目的:评价不同剂量重组呼吸道合胞病毒疫苗(CHO细胞)在18岁及以上人群接种的安全性和耐受性。次要目的:初步探索不同剂量重组呼吸道合胞病毒疫苗(CHO细胞)在18岁及以上人群接种的免疫原性。
Ⅱ期试验目的 主要目的:评价不同剂量重组呼吸道合胞病毒疫苗(CHO细胞)在60岁及以上人群接种的免疫原性。次要目的:评价不同剂量重组呼吸道合胞病毒疫苗(CHO细胞)在60岁及以上人群接种的安全性。
[Translation] Phase I Trial Objectives: Primary Objective: To evaluate the safety and tolerability of different doses of the recombinant respiratory syncytial virus (RSV) vaccine (CHO cells) in individuals aged 18 years and older. Secondary Objective: To preliminarily explore the immunogenicity of different doses of the recombinant RSV vaccine (CHO cells) in individuals aged 18 years and older.
Phase II Trial Objectives: Primary Objective: To evaluate the immunogenicity of different doses of the recombinant respiratory syncytial virus (RSV) vaccine (CHO cells) in individuals aged 60 years and older. Secondary Objective: To evaluate the safety of different doses of the recombinant respiratory syncytial virus (RSV) vaccine (CHO cells) in individuals aged 60 years and older.