多中心、随机、双盲、安慰剂对照设计评价重组带状疱疹疫苗（CHO 细胞）在 40 周岁及以上人群中接种的保护效力、免疫原性和安全性的Ⅲ期临床试验
[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.
单中心、随机、盲法、对照评价不同剂量重组带状疱疹疫苗（CHO 细胞）在 30 岁及以上健康人群中接种的免疫原性和安全性的Ⅱ期临床试验
[Translation] A single-center, randomized, blinded, controlled phase II clinical trial to evaluate the immunogenicity and safety of different doses of recombinant herpes zoster vaccine (CHO cells) in healthy people aged 30 years and above
评价在 30 岁及以上健康人群以 0,2 月 2 剂免疫程序接种不同剂量试验疫苗的免疫原性和安全性。
[Translation] To evaluate the immunogenicity and safety of different doses of the experimental vaccine in healthy people aged 30 years and above, administered in a 2-dose schedule at 0 and 2 months.
评价重组三价轮状病毒亚单位疫苗在6-12周龄、7~71月龄健康婴幼儿中接种的安全性及免疫原性的随机、双盲、安慰剂对照Ⅱ期临床试验
[Translation] A randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety and immunogenicity of a recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and 7-71 months
评价重组三价轮状病毒亚单位疫苗在6-12周龄、7-71月龄健康婴幼儿中接种的免疫原性、安全性、免疫持久性。
主要目的为评价重组三价轮状病毒亚单位疫苗在6-12周龄、7-71月龄健康婴幼儿中的免疫原性，评价重组三价轮状病毒亚单位疫苗在6-12周龄、7-71月龄健康婴幼儿中的安全性。
次要目的为评价重组三价轮状病毒亚单位疫苗疫苗在6-12周龄、7-71月龄健康婴幼儿中的免疫持久性。
[Translation] To evaluate the immunogenicity, safety, and immune persistence of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and 7-71 months.
The primary objective is to evaluate the immunogenicity of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and 7-71 months, and to evaluate the safety of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and 7-71 months.
The secondary objective is to evaluate the immune persistence of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and 7-71 months.
100 Clinical Results associated with Shanghai Maikekang Biotechnology Co., Ltd.
0 Patents (Medical) associated with Shanghai Maikekang Biotechnology Co., Ltd.
100 Deals associated with Shanghai Maikekang Biotechnology Co., Ltd.
100 Translational Medicine associated with Shanghai Maikekang Biotechnology Co., Ltd.
