[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the protective efficacy, immunogenicity and safety of recombinant herpes zoster vaccine (CHO cells) in people aged 40 years and above
主要目的:评价重组带状疱疹疫苗(CHO细胞)(以下简称“试验疫苗”)以0,2月免疫程序在40周岁及以上人群中全程免疫30天后预防带状疱疹的保护效力。
次要目的:1)评价试验疫苗以0,2月免疫程序在40-49周岁、50-59周岁、60-69周岁、≥70周岁人群中全程免疫30天后预防带状疱疹的保护效力;2)评价试验疫苗以0,2月免疫程序在40周岁及以上人群,40-49周岁、50-59周岁、60-69周岁、≥70周岁人群有效终点病例中预防任何程度〔带状疱疹简明疼痛评估量表(Zoster Brief Pain Inventory,ZBPI)评分>0〕及预防重度(ZBPI评分≥3)带状疱疹后神经痛(Postherpetic Neuralgia,PHN)的保护效力;3)评价试验疫苗的安全性;4)评价试验疫苗的免疫原性和免疫持久性。
[Translation] Main purpose: To evaluate the protective efficacy of recombinant herpes zoster vaccine (CHO cells) (hereinafter referred to as "experimental vaccine") in preventing herpes zoster in people aged 40 years and above after 30 days of full immunization with a 0-2 month immunization schedule.
Secondary objectives: 1) To evaluate the protective efficacy of the trial vaccine in preventing herpes zoster 30 days after full immunization in people aged 40-49 years, 50-59 years, 60-69 years, and ≥70 years with a 0-2 month immunization schedule; 2) To evaluate the protective efficacy of the trial vaccine in preventing any degree [Zoster Brief Pain Inventory (ZBPI) score > 0] and preventing severe (ZBPI score ≥ 3) postherpetic neuralgia (PHN) in effective endpoint cases in people aged 40 years and above, 40-49 years, 50-59 years, 60-69 years, and ≥70 years with a 0-2 month immunization schedule; 3) To evaluate the safety of the trial vaccine; 4) To evaluate the immunogenicity and immune persistence of the trial vaccine.