Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to severe diseases and death, with central nervous system (CNS) damage. Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, such as attenuated vaccine, subunit vaccine. A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016. The purpose of phase IVd is to evaluated the immunogenicity and safety of the inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese encephalitis vaccine at the same time point in large scale population of Chinese children (8 months old) in Guangdong Province, China.
Age range
8 Months – 9 Months
Sex
ALL
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Evaluate the seropositive rate of anti-EV71 antibodies in serum of children before first vaccination
Timeframe: at 0 day before finishing 1st doses immunization
Evaluate the seropositive rate of anti-EBV antibodies in serum of children before first vaccination
Timeframe: at 0 day before finishing 1st doses immunization
Evaluate the seropositive rate of anti-measles virus antibodies in serum of children before first vaccination
Timeframe: at 0 day before finishing 1st doses immunization
Evaluate the seropositive rate of anti-Rubella virus antibodies in serum of children before first vaccination
Timeframe: at 0 day before finishing 1st doses immunization
Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children at 56 days after first vaccination
Timeframe: at 56 days after finishing 1st doses immunization
Evaluate the seroconversion rate of anti-EBV antibodies in serum of children at 56 days after first vaccination
Timeframe: at 56 days after finishing 1st doses immunization
Evaluate the seroconversion rate of anti-measles virus antibodies in serum of children at 56 days after first vaccination
Timeframe: at 56 days after finishing 1st doses immunization
Evaluate the seroconversion rate of anti-Rubella virus antibodies in serum of children at 56 days after first vaccination
Timeframe: at 56 days after finishing 1st doses immunization