[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the protective efficacy of recombinant herpes zoster vaccine (CHO cells) in adults aged 40 years and above
主要目的:
评价全程接种重组带状疱疹疫苗( 细胞) 天后预防带状疱疹(Zoster,HZ)的保护效力。
次要目的:
评价重组带状疱疹疫苗( 细胞)的安全性;
评价重组带状疱疹疫苗( 细胞)的免疫原性;
评价重组带状疱疹疫苗( 细胞)接种 天后预防任何程度带状疱疹后遗神经痛(Post herpetic Neuralgia, PHN PHN)(ZBPIZBPI(带状疱疹简明疼痛量表)评分>0
0)和重度PHN( 分级≥3)的保护效力。
[Translation] Primary objective:
To evaluate the protective efficacy of recombinant herpes zoster vaccine (Zoster, HZ) after full vaccination for 15 days.
Secondary objectives:
To evaluate the safety of recombinant herpes zoster vaccine (Zoster);
To evaluate the immunogenicity of recombinant herpes zoster vaccine (Zoster);
To evaluate the protective efficacy of recombinant herpes zoster vaccine (Zoster) after 15 days of vaccination for preventing any degree of postherpetic neuralgia (PHN) (ZBPI score >0) and severe PHN (grade ≥3).