3
Clinical Trials associated with Rotavirus vaccine,live(Wuhan Institute of Biological Products)评价口服六价重配轮状病毒活疫苗在婴幼儿中的保护效力、安全性和免疫原性的Ⅲ期临床试验
[Translation] A phase III clinical trial to evaluate the protective efficacy, safety and immunogenicity of an oral hexavalent reassortant rotavirus live vaccine in infants and young children
主要目的为评价接种3剂六价重配轮状病毒活疫苗14天后预防自然感染轮状病毒引起的重度急性胃肠炎的保护效力,次要目的为评价接种14天后预防自然感染任何型别、疫苗株所含型别轮状病毒以及所有原因导致的急性胃肠炎的保护效力,预防疫苗株所含型别引起的重度急性胃肠炎的保护效力,疫苗接种的安全性和免疫原性。
[Translation] The primary objective is to evaluate the protective efficacy of three doses of hexavalent reassortant live rotavirus vaccine against severe acute gastroenteritis caused by natural infection with rotavirus 14 days after vaccination. The secondary objective is to evaluate the protective efficacy against natural infection with any type of rotavirus, types contained in the vaccine strain and acute gastroenteritis caused by all causes 14 days after vaccination, the protective efficacy against severe acute gastroenteritis caused by types contained in the vaccine strain, and the safety and immunogenicity of vaccination.
评价不同剂量口服六价重配轮状病毒活疫苗免疫原性和安全性的随机、盲法、安慰剂对照的Ⅱ期临床试验
[Translation] A randomized, blinded, placebo-controlled phase II clinical trial to evaluate the immunogenicity and safety of different doses of oral hexavalent reassortant live rotavirus vaccine
主要目的为评价不同剂量口服六价重配轮状病毒活疫苗在6周-12周龄健康婴儿中的免疫原性,次要目的为评价不同剂量口服六价重配轮状病毒活疫苗在6周-12周龄健康婴儿中的安全性。
[Translation] The primary objective was to evaluate the immunogenicity of different doses of oral hexavalent reassortant rotavirus live vaccine in healthy infants aged 6 to 12 weeks. The secondary objective was to evaluate the safety of different doses of oral hexavalent reassortant rotavirus live vaccine in healthy infants aged 6 to 12 weeks.
评价口服六价重配轮状病毒活疫苗的安全性和耐受性,探索免疫原性的随机、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 tolerability of an oral hexavalent reassortant live rotavirus vaccine and explore its immunogenicity
主要目的为评价不同剂量口服六价重配轮状病毒疫苗在6周龄以上健康人群中的安全性与耐受性,次要目的为初步探索免疫原性,评估粪便中轮状病毒排便时间及排毒率以及轮状病毒疫苗毒株的重配、返祖情况。
[Translation] The main objective is to evaluate the safety and tolerability of different doses of oral hexavalent reassortant rotavirus vaccine in healthy people over 6 weeks of age. The secondary objective is to preliminarily explore the immunogenicity, evaluate the time and rate of rotavirus excretion in feces, and the reassortment and atavism of rotavirus vaccine strains.
100 Clinical Results associated with Rotavirus vaccine,live(Wuhan Institute of Biological Products)
100 Translational Medicine associated with Rotavirus vaccine,live(Wuhan Institute of Biological Products)
100 Patents (Medical) associated with Rotavirus vaccine,live(Wuhan Institute of Biological Products)
100 Deals associated with Rotavirus vaccine,live(Wuhan Institute of Biological Products)