随机、盲法、对照设计评价重组带状疱疹疫苗(CHO细胞)在40岁及以上健康人群中接种后的安全性和免疫原性的Ⅰ/Ⅱ期临床试验
[Translation] A randomized, blinded, controlled phase Ⅰ/Ⅱ clinical trial to evaluate the safety and immunogenicity of a recombinant herpes zoster vaccine (CHO cells) in healthy people aged 40 years and above
(1)Ⅰ期
评价不同佐剂剂量重组带状疱疹疫苗(CHO细胞)在40岁及以上健康人群中的安全性和耐受性。
(2)Ⅱ期
主要目的
1)评价不同佐剂剂量重组带状疱疹疫苗(CHO细胞)在40岁及以上健康人群中的免疫原性,为Ⅲ期临床试验佐剂剂量和免疫程序的选择提供参考依据。
2)评价不同佐剂剂量重组带状疱疹疫苗(CHO细胞)在40岁及以上健康人群中的安全性。
次要目的
评价不同佐剂剂量重组带状疱疹疫苗(CHO细胞)在40岁及以上健康人群中的免疫持久性。
[Translation] (1) Phase I
To evaluate the safety and tolerability of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and above.
(2) Phase II
Main objectives
1) To evaluate the immunogenicity of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and above, and to provide a reference for the selection of adjuvant doses and immunization schedules in Phase III clinical trials.
2) To evaluate the safety of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and above.
Secondary objectives
To evaluate the immune persistence of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and above.
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