Target- |
MechanismImmunostimulants |
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Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项采用随机、盲法设计,评估重组带状疱疹疫苗(CHO细胞)LZ901对比同类阳性疫苗在50岁及以上人群中免疫原性和安全性的临床试验
[Translation] A clinical trial using a randomized, blinded design to evaluate the immunogenicity and safety of recombinant herpes zoster vaccine (CHO cell) LZ901 compared with similar positive vaccines in people aged 50 years and older.
与对照疫苗比较,评价重组带状疱疹疫苗(CHO细胞)LZ901在50岁以及上人群中诱生细胞免疫的免疫原性。
[Translation] Compared with the control vaccine, the immunogenicity of the recombinant herpes zoster vaccine (CHO cell) LZ901 in inducing cellular immunity in people aged 50 years and above was evaluated.
一项采用多中心、随机、双盲、安慰剂对照设计,用于评价在40岁及以上人群中接种重组带状疱疹疫苗(CHO细胞)保护效力、安全性的Ⅲ期临床试验。
[Translation] A phase III clinical trial using a multi-center, randomized, double-blind, placebo-controlled design to evaluate the protective efficacy and safety of recombinant herpes zoster vaccine (CHO cells) in people aged 40 years and above.
1、与安慰剂比较,评价重组带状疱疹疫苗(CHO细胞)在≥40岁人群中全程免 疫30天后预防带状疱疹的保护效力(Vaccine Efficacy,VE);
2、评价3个批次重组带状疱疹疫苗(CHO细胞)在≥40岁人群中的批间免疫原性一致性(免疫亚组)。
[Translation] 1. To evaluate the protective efficacy (Vaccine Efficacy, VE) of the recombinant herpes zoster vaccine (CHO cell) in preventing herpes zoster 30 days after full immunization in people aged ≥40 years compared with placebo;
2. Evaluate the inter-batch immunogenicity consistency (immune subgroup) of 3 batches of recombinant herpes zoster vaccine (CHO cells) in people aged ≥40 years.
随机、双盲、安慰剂对照设计评估重组带状疱疹疫苗在50-70岁健康人群使用的免疫原性和安全性的II期临床研究
[Translation] Phase II clinical study evaluating the immunogenicity and safety of recombinant herpes zoster vaccine in healthy people aged 50-70 years with a randomized, double-blind, placebo-controlled design
评价不同剂量的重组带状疱疹疫苗(CHO细胞)在50-70岁健康人群中接种的免疫原性和安全性
[Translation] To evaluate the immunogenicity and safety of different doses of recombinant herpes zoster vaccine (CHO cells) in healthy people aged 50-70 years
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