Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Chaoyang District Centre for Disease Control and Prevention | OTHER |
| Neimenggu Province Centre for Disease Control and Prevention | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 IV is to evaluated the safety and efficacy of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).
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 IV is to evaluated the safety and efficacy of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).
There are three parts of phase IV clinical trials have been performed. First, to evaluate the safety of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).
Second, to evaluate the immune persistence of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).
Third, to evaluate the efficacy of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3.0 EU in Children | Experimental | healthy children (6-71 months old) have been injected by inactivated EV71 vaccine (KMB-17) of 3.0 EU (neutralization antibodies titer unit; 100 U in phase III clinical trials, or 320 EU (Elisa assay unit) in phase I and II clinical trials) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inactivated EV71 vaccine (KMB-17) | Biological | 3.0EU of inactivated enterovirus 71 vaccine (KMB-17) on day 0, 28. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment adverse events | The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-7 days post immunization (d.p.i.) and within 8-28 d.p.i after the 1st injection, as well as after the 2nd injection. And the adverse events were also observed and recorded following within 24 months after finishing 2 doses immunization. | Up to 24 months after finishing 2 doses immunization |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence rates of HFMD | All hand, foot and mouth disease (HFMD) cases from the subjects were observed and recorded, including common cases, severe cases, dead cases, the cases caused by enterovirus 71, the severe cases caused by enterovirus 71, the dead cases caused by enterovirus 71. The incidence rates of the subjects from this clinical trial were calculated. | Up to 24 months after finishing 2 doses immunization |
| Measure | Description | Time Frame |
|---|---|---|
| The level of anti-EV71 antibodies was evaluated in serum of children | The blood specimens were obtained at 0, 28, 56, 180, 360 and 720 days post the 1st immunization (p.i.). The levels of neutralization antibodies were tested at each time point. The level of anti-EV71 antibodies was evaluated in serum of children. | Up to 24 months after finishing 2 doses immunization |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nianmin Shi, M.S. | Chaoyang Provincial Center for Diseases Control and Prevention in Beijing | Principal Investigator |
| Shaohong Yan, M.S. | Neimenggu Provincial Center for Diseases Control and Prevention | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaoyang of Provincial Center for Diseases Control and Prevention in Beijing | Beijing | 100021 | China |
Participants do not agree to share individual data.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| immune response of inactivated EV71 vaccine (KMB-17) in a large crowd | The blood specimens were obtained at 0, 28, 56, 180, 360 and 720 days post the 1st immunization (p.i.). The levels of neutralization antibodies and cytokines were tested at each time point. The seroconversion rate of anti-EV71 antibodies was evaluated in serum of children. And the specific IFN-γ in subjects were tested and evaluated at 0, 180 and 360 d.p.i.. | Up to 24 months after finishing 2 doses immunization |