/ Active, not recruitingPhase 3 随机、双盲评价生产规模下连续三批重组带状疱疹疫苗（CHO细胞）在40周岁及以上人群中接种后的免疫原性批间一致性的Ⅲ期临床试验
[Translation] A randomized, double-blind phase III clinical trial to evaluate the consistency of immunogenicity between three consecutive batches of recombinant herpes zoster vaccine (CHO cells) in people aged 40 years and above at production scale
主要目的：
评价商业化规模下生产的连续三批次重组带状疱疹疫苗（CHO细胞）按0，2月各1剂免疫程序接种于40周岁及以上人群后，在抗-gE抗体几何平均浓度（Geometric Mean Concentration, GMC）方面的批间一致性。
次要目的： 评价商业化规模下生产的连续三批次重组带状疱疹疫苗（CHO细胞）按0，2月各1剂免疫程序接种于40周岁及以上人群后，在抗-gE抗体阳转率方面的批间一致性；
评价商业化规模生产的重组带状疱疹疫苗（CHO细胞）按0，2月各1剂免疫程序接种于40周岁及以上人群的安全性。
[Translation] Primary objective:
To evaluate the batch-to-batch consistency of the anti-gE antibody geometric mean concentration (GMC) of three consecutive batches of recombinant herpes zoster vaccine (CHO cells) produced on a commercial scale, which were administered to people aged 40 years and above at 0 and 2 months, respectively.
Secondary objective: To evaluate the batch-to-batch consistency of the anti-gE antibody positive conversion rate of three consecutive batches of recombinant herpes zoster vaccine (CHO cells) produced on a commercial scale, which were administered to people aged 40 years and above at 0 and 2 months, respectively;
To evaluate the safety of recombinant herpes zoster vaccine (CHO cells) produced on a commercial scale, which were administered to people aged 40 years and above at 0 and 2 months, respectively.
/ Active, not recruitingPhase 1/2 单中心、随机、双盲、安慰剂对照设计评价重组呼吸道合胞病毒疫苗（CHO细胞）在18周岁及以上人群中接种的安全性、免疫原性的Ⅰ/II期临床试验
[Translation] A single-center, randomized, double-blind, placebo-controlled Phase I/II clinical trial to evaluate the safety and immunogenicity of a recombinant respiratory syncytial virus vaccine (CHO cells) in people aged 18 years and above
评价不同剂量重组呼吸道合胞病毒疫苗（CHO细胞）在18周岁及以上人群的安全性和免疫原性。
[Translation] To evaluate the safety and immunogenicity of different doses of recombinant respiratory syncytial virus vaccine (CHO cells) in people aged 18 years and above.
/ Active, not recruitingPhase 3 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.
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.
