A Phase 4 interventional study of EV71 and two measles attenuated live vaccine and EV71 and attenuated Japanese encephalitis vaccine in Hand, Foot and Mouth Disease (HFMD), sponsored by Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 8 Months to 9 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-28.
Sponsored by Chinese Academy of Medical Sciences · Phase 4, Interventional, and Prevention
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Among 41 studies in Hand, Foot and Mouth Disease with a site in China — 6 open to participants now, 7 under way, 2 of them phase 3. Hand, Foot and Mouth Disease · China.
Among the 41 studies in Hand, Foot and Mouth Disease with a site in China, this one is the 13th largest by planned enrollment of the 36 interventional ones that give a count, is one of 5 that started in 2017, is one of 14 in phase 4, and was the 19th registered.
59 studies on the registry are indexed under Hand, Foot and Mouth Disease; 10 are open to participants now.
Browse Hand, Foot and Mouth Disease studies →6 of the 41 studies in Hand, Foot and Mouth Disease with a site in China are open now. Recruiting first, the newest first:
Sinovac Biotech Co., Ltd · Sites in China
Ages 6 mo–71 mo · Healthy volunteers
Southern Medical University, China · Sites in China
Healthy volunteers
Institute of Medical Biology, Chinese Academy of Medical Sciences · Sites in China
Ages 6 mo–35 mo · Healthy volunteers
Institute of Medical Biology, Chinese Academy of Medical Sciences · Sites in China
Healthy volunteers
Sinovac Biotech Co., Ltd · Sites in China
Ages 6 mo–71 mo · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 4 Hand, Foot and Mouth Disease studies recruiting now, 1 sets no upper age limit and 3 stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 8 Months to 9 Months · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 3 · Phase 3 7 · Phase 4 14
First in 2010; this study’s year is marked. 5 started in 2017.
This study's planned enrollment of 1,220 is above the median of 467 across 50 interventional studies indexed under Hand, Foot and Mouth Disease.
Median enrollment 702 across the 36 interventional studies, 1,297 across the 5 observational. Of the 26 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
19 of 41 have an industry lead sponsor. The 10 most frequent:
Chinese Academy of Medical Sciences is the lead sponsor of 237 studies on the registry; 19 are open to participants now.
Chinese Academy of Medical Sciences has 2 studies filed under Hand, Foot and Mouth Disease — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 41 studies in Hand, Foot and Mouth Disease with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) and two measles attenuated live vaccine at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.
Biological: EV71 and two measles attenuated live vaccine
infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) and live attenuated Japanese encephalitis vaccine at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.
Biological: EV71 and attenuated Japanese encephalitis vaccine
infants vaccinated with two measles attenuated live vaccine at 8 months old
Biological: two measles attenuated live vaccine
infants vaccinated with live attenuated Japanese encephalitis vaccine at 8 months old
Biological: live attenuated Japanese encephalitis vaccine
infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.
Biological: EV71 vaccine
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).
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
Started Sep 2017 (actual). Primary completion is estimated for Sep 2019, 23 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Hand, Foot and Mouth Disease →
Chinese Academy of Medical Sciences →