[Translation] A randomized, double-blind, placebo-controlled phase I/II clinical trial to evaluate the safety, tolerability and immunogenicity of a recombinant respiratory syncytial virus vaccine (SCTV02) in healthy people aged ≥18 years
Ⅰ期研究:
主要目的:评估SCTV02在≥18周岁人群中的安全性。
次要目的:评估SCTV02在≥18周岁人群中接种后180天内的安全性;评估SCTV02在≥18周岁人群中的免疫原性。
Ⅱ期研究:
主要目的:评估SCTV02在≥50周岁人群中的免疫原性;评估SCTV02在≥50周岁人群中的安全性。
次要目的:评估SCTV02在≥50周岁人群中接种1剂研究疫苗后365天内的安全性;评估第2剂SCTV02在≥50周岁人群中接种后的安全性;评估第2剂SCTV02在≥50周岁人群中接种后的免疫原性。
[Translation] Phase I study:
Primary objective: To evaluate the safety of SCTV02 in people aged ≥18 years.
Secondary objective: To evaluate the safety of SCTV02 within 180 days after vaccination in people aged ≥18 years; To evaluate the immunogenicity of SCTV02 in people aged ≥18 years.
Phase II study:
Primary objective: To evaluate the immunogenicity of SCTV02 in people aged ≥50 years; To evaluate the safety of SCTV02 in people aged ≥50 years.
Secondary objective: To evaluate the safety of SCTV02 within 365 days after 1 dose of the study vaccine in people aged ≥50 years; To evaluate the safety of the second dose of SCTV02 in people aged ≥50 years; To evaluate the immunogenicity of the second dose of SCTV02 in people aged ≥50 years.