[Translation] A randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability and immunogenicity of oral hexavalent reassortant rotavirus live attenuated vaccine (Vero cells) in healthy adults and children and in healthy infants
主要目的:评价轮状疫苗在健康成人、儿童和婴儿中的安全性;
次要目的:评价轮状疫苗在健康成年人、儿童和婴儿中的安全性;评价轮状疫苗在健康婴儿中的免疫原性和免疫持久性;评价健康婴儿接种轮状疫苗后的粪便排毒情况;评价健康婴儿接种轮状疫苗后的粪便样本中轮状疫苗毒株重配、返祖情况。
[Translation] Primary objective: To evaluate the safety of rotavirus vaccine in healthy adults, children and infants;
Secondary objectives: To evaluate the safety of rotavirus vaccine in healthy adults, children and infants; To evaluate the immunogenicity and immune persistence of rotavirus vaccine in healthy infants; To evaluate the fecal excretion of rotavirus vaccine in healthy infants after rotavirus vaccine vaccination; To evaluate the reassortment and reversion of rotavirus vaccine strains in fecal samples of healthy infants after rotavirus vaccine vaccination.