Target- |
MechanismImmunostimulants |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Not yet recruitingPhase 1 评价冻干呼吸道合胞病毒mRNA疫苗(NR222)在18周岁及以上人群中接种的安全性及初步免疫原性的随机、盲法、安慰剂对照的Ⅰ期临床试验
[Translation] A randomized, blinded, placebo-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of freeze-dried respiratory syncytial virus mRNA vaccine (NR222) in people aged 18 years and above
主要目的:
评价冻干呼吸道合胞病毒mRNA疫苗在18周岁及以上受试者中接种的安全性和耐受性。
次要目的:
评价冻干呼吸道合胞病毒mRNA疫苗在18周岁及以上受试者中接种的免疫原性。
探索性目的:
(1) 评价冻干呼吸道合胞病毒mRNA疫苗在18周岁及以上受试者中接种的免疫持久性;
(2) 评价冻干呼吸道合胞病毒mRNA疫苗在18周岁及以上受试者中接种的细胞免疫情况。
[Translation] Primary objective:
To evaluate the safety and tolerability of freeze-dried respiratory syncytial virus mRNA vaccine in subjects aged 18 years and above.
Secondary objective:
To evaluate the immunogenicity of freeze-dried respiratory syncytial virus mRNA vaccine in subjects aged 18 years and above.
Exploratory objectives:
(1) To evaluate the immune persistence of freeze-dried respiratory syncytial virus mRNA vaccine in subjects aged 18 years and above;
(2) To evaluate the cellular immunity of freeze-dried respiratory syncytial virus mRNA vaccine in subjects aged 18 years and above.
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