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Clinical Trials associated with Group ACYW135 Meningococcal Conjugate Vaccine (Zhejiang Vacin Biomedicine) / Active, not recruitingPhase 2 评价ACYW135群脑膜炎球菌多糖结合疫苗在3月龄至15周岁人群中接种的免疫原性和安全性的随机、双盲、同类疫苗平行对照设计Ⅱ期临床试验
[Translation] A randomized, double-blind, parallel-controlled phase II clinical trial to evaluate the immunogenicity and safety of group ACYW135 meningococcal polysaccharide conjugate vaccine in people aged 3 months to 15 years
主要目的:
1) 评价3~5月龄受试者基础免疫后的免疫原性和安全性;
2) 评价6~23月龄受试者全程免疫后的免疫原性和安全性;
3) 评价2~15周岁受试者全程免疫后的免疫原性和安全性。
次要目的:
1) 评价3~5月龄受试者加强免疫后的免疫原性和安全性;
2) 评价3~5月龄、6~11月龄、12~23月龄受试者的免疫持久性。
[Translation] Main objectives:
1) To evaluate the immunogenicity and safety of subjects aged 3 to 5 months after basic immunization;
2) To evaluate the immunogenicity and safety of subjects aged 6 to 23 months after full immunization;
3) To evaluate the immunogenicity and safety of subjects aged 2 to 15 years after full immunization.
Secondary objectives:
1) To evaluate the immunogenicity and safety of subjects aged 3 to 5 months after booster immunization;
2) To evaluate the immune persistence of subjects aged 3 to 5 months, 6 to 11 months, and 12 to 23 months.
/ Not yet recruitingPhase 2 A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in People Aged 3 Months to 15 Years Old in a Randomized, Double-blind, Parallel Controlled Design
The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination.
/ Active, not recruitingPhase 1 ACYW135群脑膜炎球菌多糖结合疫苗接种于3月龄及以上健康人群的Ⅰ期安全性研究
[Translation] Phase I safety study of ACYW135 group meningococcal polysaccharide conjugate vaccine in healthy people aged 3 months and above
评价ACYW135群脑膜炎球菌多糖结合疫苗接种于3月龄及以上健康人群的安全性
[Translation] To evaluate the safety of ACYW135 group meningococcal polysaccharide conjugate vaccine in healthy people aged 3 months and above
100 Clinical Results associated with Group ACYW135 Meningococcal Conjugate Vaccine (Zhejiang Vacin Biomedicine)
100 Translational Medicine associated with Group ACYW135 Meningococcal Conjugate Vaccine (Zhejiang Vacin Biomedicine)
100 Patents (Medical) associated with Group ACYW135 Meningococcal Conjugate Vaccine (Zhejiang Vacin Biomedicine)
100 Deals associated with Group ACYW135 Meningococcal Conjugate Vaccine (Zhejiang Vacin Biomedicine)