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.
There are two parts of phase IVd clinical trials have been performed. First, to evaluate the immunogenicity 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), within 56-day-post-immunized. Second, to 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), within 56-day-post-immunized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,220
infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with two measles attenuated live vaccine at 8 months old.
infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with attenuated Japanese encephalitis vaccine at 8 months old.
infants vaccined with one dose two measles attenuated live vaccine at 8 months old.
infants vaccined with one dose attenuated Japanese encephalitis vaccine at 8 months old.
infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month).
Guangdong Province Center for Diseases Control and Prevention
Guangzhou, Guangdong, China
Evaluate the seropositive rate of anti-EV71 antibodies in serum of children before first vaccination
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
Time frame: at 0 day before finishing 1st doses immunization
Evaluate the seropositive rate of anti-EBV antibodies in serum of children before first vaccination
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
Time frame: at 0 day before finishing 1st doses immunization
Evaluate the seropositive rate of anti-measles virus antibodies in serum of children before first vaccination
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
Time frame: at 0 day before finishing 1st doses immunization
Evaluate the seropositive rate of anti-Rubella virus antibodies in serum of children before first vaccination
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
Time frame: 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
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
Time frame: 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
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
Time frame: 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
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
Time frame: 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
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
Time frame: at 56 days after finishing 1st doses immunization
Evaluate the antibody titers of anti-EV71 antibodies in serum of children
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
Time frame: at 56 days after finishing 1st doses immunization
Evaluate the antibody titers of anti-EBV antibodies in serum of children
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
Time frame: at 56 days after finishing 1st doses immunization
Evaluate the antibody titers of anti-measles virus antibodies in serum of children
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
Time frame: at 56 days after finishing 1st doses immunization
Evaluate the antibody titers of anti-Rubella virus antibodies in serum of children
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
Time frame: at 56 days after finishing 1st doses immunization
Incidence of treatment adverse events finishing 1st doses immunization
The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-1 days post immunization (d.p.i.), within 1-3 d.p.i. and within 28 d.p.i. after the 1st injection.
Time frame: within 28 days after finishing 1st doses immunization
Incidence of treatment adverse events finishing 2nd doses immunization
The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-1 days post immunization (d.p.i.), within 1-3 d.p.i. and within 28 d.p.i. after injection.
Time frame: within 28 days after finishing 2nd doses immunization
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