A Phase 4 interventional study of EV71 Vaccine in Hand, Foot and Mouth Disease, sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences. Recruiting at 4 sites in China. Open to participants aged 6 Months to 35 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Institute of Medical Biology, 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 11th largest by planned enrollment of the 36 interventional ones that give a count, is one of 2 that started in 2023, is one of 14 in phase 4, and was the 34th 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
Healthy volunteers
Sinovac Biotech Co., Ltd · Sites in China
Ages 6 mo–71 mo · Healthy volunteers
Institute of Medical Biology, Chinese Academy of Medical Sciences · Sites in China
Ages 6 mo–59 yrs · 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: 6 Months to 35 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. 2 started in 2023.
This study's planned enrollment of 1,500 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:
Institute of Medical Biology, Chinese Academy of Medical Sciences is the lead sponsor of 29 studies on the registry; 10 are open to participants now.
Institute of Medical Biology, Chinese Academy of Medical Sciences has 7 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.
This study is a randomized, blinded study to evaluate the lot-to-lot consistency of immunogenicity, safety, and immune persistence of three consecutive manufacturing lots of EV71 vaccine, in 1500 children aged 6-35 months. The primary immunogenicity endpoint is the anti-EV71 neutralizing antibody geometric mean titer (GMT) 30 days after the final dose. The secondary immunogenicity endpoints are the geometric mean fold increases and seroconversion rates of anti-EV71 neutralizing antibodies 30 days after the final dose. The immune persistence endpoints are the seropositive rates as well as GMT of anti-EV71 neutralizing antibodies 12 and 24 months after the final dose. The safety endpoints are the number of adverse events/reactions within 30 minutes after each dose, the number of solicited adverse events/reactions within 7 days after each dose, the number of unsolicited adverse events/reactions within 30 days after each dose, and the number of serious adverse events (SAE) from the first dose to 6 months post the final dose.
This study is a randomized, blinded study to evaluate the lot-to-lot consistency of immunogenicity, safety, and immune persistence of three consecutive manufacturing lots of EV71 vaccine, in children aged 6-35 months. The study is conducted to enroll 1500 healthy participants, including 600 infants aged 6-11 months, 600 toddlers aged 12-23 months, and 300 children aged 24-35 months. Eligibility will be assessed through medical history and physical examination. Participants from each age group will be randomly assigned to three different batch groups in a ratio of 1:1:1, that is, 500 participants in total will be in each lot arm, respectively.
All participants will receive an injection of the EV71 vaccine in the anterolateral midthigh or deltoid muscle of the upper arm on Day 0 and Day 30, respectively. The duration of interventions for each participant is approximately 1 month, thus, the duration of the immune persistence study for each participant is approximately 25 months.
For immunogenicity and immune persistence assessment, neutralizing antibodies against EV71 of all participants will be assessed on the first day (Day 0) before administration, 30 days after the final dose, and 12 and 24 months after the final dose, respectively.
For safety assessment, observation of adverse events (AE) from Day 0 to Day 30 after each dose of vaccination will be evaluated by diary or contact cards. Simultaneously, the serious adverse event (SAE) between the first dose of the vaccine to 6 months after the final dose will be evaluated by diary or contact cards, active reports, investigators' phone calls, or on-site visits. Meanwhile, participants will be observed at clinical sites for at least 30 minutes.
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:
[First Dose Exclusion Criterions] Subjects meeting any of the following exclusion criteria will not be eligible for enrollment
[ of the second dose of vaccine] Subjects meeting any of the following exclusion criteria will not be eligible for the second dose of the investigational vaccine
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 drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inactivated Enterovirus 71 Vaccine (human diploid cell) in children aged 6-35 months old on Day 0 and Day 30 approved by the National Institute for Food and Drug Control
Biological: EV71 Vaccine
Inactivated Enterovirus 71 Vaccine (human diploid cell) in children aged 6-35 months old on Day 0 and Day 30 approved by the National Institute for Food and Drug Control
Biological: EV71 Vaccine
Inactivated Enterovirus 71 Vaccine (human diploid cell) in children aged 6-35 months old on Day 0 and Day 30 approved by the National Institute for Food and Drug Control
Biological: EV71 Vaccine
Inactivated enterovirus 71 vaccine (human diploid cell) of 3.0EU/0.5mL on Day 0,30
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method
Time frame: Day 30 after the second vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method
Time frame: Between baseline and Day 30 after the second vaccination
Immunogenicity index-seroconversion rates of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or ≥4-fold increase from baseline
Time frame: Between baseline and Day 30 after the second vaccination
Immunogenicity index-seropositive rates of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method. Seropositive will be defined as the positive results with ties≥1:8
Time frame: Day 30, 12 months, and 24 months after the second vaccination
Safety index-incidence of adverse reactions/events
Incidence of adverse reactions/events after the first dose vaccination
Time frame: 0-30 minutes after the first dose vaccination
Safety index-incidence of adverse reactions/events
Incidence of adverse reactions/events after the second dose vaccination
Time frame: 0-30 minutes after the second dose vaccination
Safety index-incidence of adverse reactions/events
Incidence of solicited adverse reactions/events after the first dose vaccination
Time frame: Day 0 to Day 7 after the first dose vaccination
Safety index-incidence of adverse reactions/events
Incidence of solicited adverse reactions/events after the second dose vaccination
Time frame: Day 0 to Day 7 after the second dose vaccination
Safety index-incidence of adverse reactions/events
Incidence of unsolicited adverse reactions/events after the first dose vaccination
Time frame: Day 0 to Day 30 after the first dose vaccination
Safety index-incidence of adverse reactions/events
Incidence of unsolicited adverse reactions/events after the second dose vaccination
Time frame: Day 0 to Day 30 after the second dose vaccination
Safety index-incidence of serious adverse reactions/events
Occurrence of serious adverse reactions/events after vaccination
Time frame: From the first dose to 6 months post the last dose of vaccination completed
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Mar 2024, 4 months after the start.
How these figures are worked out, and which studies are left out of them.
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Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Enterovirus 71 vaccine
Hand, Foot and Mouth Disease →
Institute of Medical Biology, Chinese Academy of Medical Sciences