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Clinical Trials associated with Recombinant Bivalent(GI.1/GII.4) norovirus vaccine (National Vaccine and Serum Institute) / Not yet recruitingPhase 3 A Phase III Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula Polymorpha) in Healthy People Aged 6 Months to 13 Years
The purpose of this study is to evaluate the Efficacy, Safety and Immunogenicity of the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha) in Healthy People Aged 6 Months to 13 Years After Vaccination
/ Active, not recruitingPhase 2 评价重组诺如病毒双价(GI.1/GII.4)疫苗(汉逊酵母)接种于6月龄~59岁健康人群免疫原性和安全性的随机、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 immunogenicity and safety of a recombinant norovirus bivalent (GI.1/GII.4) vaccine (Hansen yeast) in healthy people aged 6 months to 59 years
评价6月龄~59岁健康人群接种不同剂量重组诺如病毒双价(GI.1/GII.4)疫苗(汉逊酵母)全程免疫后14天的免疫原性。进一步评价在6月龄~59岁健康人群接种不同剂量试验疫苗的安全性;探索试验疫苗在6月龄~59岁健康人群中的免疫持久性。
[Translation] To evaluate the immunogenicity of different doses of recombinant norovirus bivalent (GI.1/GII.4) vaccine (Hansen yeast) in healthy people aged 6 months to 59 years 14 days after full immunization. To further evaluate the safety of different doses of the experimental vaccine in healthy people aged 6 months to 59 years; to explore the immune persistence of the experimental vaccine in healthy people aged 6 months to 59 years.
A Randomized, Blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenulapolymorpha) in Healthy People Aged 6 Months to 59 Years
A total of 450 subjects were enrolled, divided into four age groups, including 18-59 years, 6-17 years, 3-5 years, and 6-35 months. There are three types of the test vaccine component in each age group. A total of 30 people in each dose group were vaccinated with the test vaccine or placebo 1 or placebo 2, respectively, in a ratio of 3: 1: 1.
The 18-59-year-old, 6-17-year-old, and 3-5-year-old age groups were vaccinated 2 times at a time interval of 28 days. The 6-35 month age group is divided into two groups, Group 1 is inoculated with 2 doses interval of 28 days each, and Group 2 is inoculated with 3 doses interval of 28 days.
100 Clinical Results associated with Recombinant Bivalent(GI.1/GII.4) norovirus vaccine (National Vaccine and Serum Institute)
100 Translational Medicine associated with Recombinant Bivalent(GI.1/GII.4) norovirus vaccine (National Vaccine and Serum Institute)
100 Patents (Medical) associated with Recombinant Bivalent(GI.1/GII.4) norovirus vaccine (National Vaccine and Serum Institute)
100 Deals associated with Recombinant Bivalent(GI.1/GII.4) norovirus vaccine (National Vaccine and Serum Institute)