A Phase 4 interventional study of EV71 vaccine in Hand, Foot and Mouth Disease, sponsored by Sinovac Biotech Co., Ltd. Completed at 1 site in China. Open to participants aged 6 Months to 35 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-02.
Sponsored by Sinovac Biotech Co., Ltd · Phase 4, Interventional, and Prevention
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Among 20 studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd — 4 open to participants now, 4 under way, 2 of them phase 3. Hand, Foot and Mouth Disease · Sinovac Biotech Co., Ltd.
Among the 20 studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd, this one is the 15th largest by enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2017, is one of 6 in phase 4, and was the 6th 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 →4 of the 20 studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd are open now, in 2 countries. Recruiting first, the newest first:
Sinovac Biotech Co., Ltd · Sites in China
Ages 6 mo–71 mo · Healthy volunteers
Sinovac Biotech Co., Ltd · Sites in Vietnam
Ages 6 mo–71 mo · Healthy volunteers
Sinovac Biotech Co., Ltd · Sites in China
Ages 6 mo–71 mo · Healthy volunteers
Sinovac Biotech Co., Ltd
Ages 6 mo–18 yrs
By country, each count listing its studies:
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.
20 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 3 · Phase 2 2 · Phase 3 5 · Phase 4 6
First in 2011; this study’s year is marked. 3 started in 2017.
This study's enrollment of 120 is below the median of 467 across 50 interventional studies indexed under Hand, Foot and Mouth Disease.
Median enrollment 744 across the 15 interventional studies, 600 across the 5 observational. Of the 14 that completed or were terminated, 0 (0%) have results posted.
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Sinovac Biotech Co., Ltd is the lead sponsor of 93 studies on the registry; 19 are open to participants now.
1 of the studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07793175Sinovac Biotech Co., LtdBridging Clinical Trial of EV71 Vaccine in Vietnamese Children | 2027-01-09 |
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Among the 20 studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different time after vaccination
This study is an open-labelled, single-centered, stratified-randomized, phase IV clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine (developed by Sinovac Biotech Co., Ltd.) in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different times after vaccination. The enrolled subjects in this study receive two doses of EV71 vaccine with 1-month interval between doses. To evaluate safety of the vaccine, subjects will be observed for 30 days after the injection for the potential adverse events. To evaluate the immunogenicity of the vaccine, venous blood will be collected for the neutralizing antibody detection prior to vaccination, 10/20/30 days after the 1st dose and 30 days after the 2nd dose vaccination. All subjects will receive blood sampling for three times. Subjects will be randomly assigned to receive blood sampling at 10/20/30 days after 1st dose injection, with a ratio of 1: 1: 1.
Inclusion Criteria:
Exclusion Criteria:
For subjects with any of the following conditions, vaccination should not be administrated:
Exclusion Criteria of the Second Injection:
Subjects with any of the following conditions are forbidden to continue the 2nd dose of vaccination:
Subjects with the following conditions may receive vaccination in delayed time or withdraw from the study depending on the judgment of investigator
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
This group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 10, and 60 respectively for EV71 neutralizing antibody detection.
Biological: EV71 vaccine
This group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 20, and 60 respectively for EV71 neutralizing antibody detection.
Biological: EV71 vaccine
This group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 30, and 60 respectively for EV71 neutralizing antibody detection.
Biological: EV71 vaccine
Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.
The seroconversion rate of EV71 neutralizing antibody 30 days after the two doses vaccination
Immunogenicity indicator
Time frame: 30 days
The seroconversion rate of EV71 neutralizing antibody 10, 20 and 30 days after the first dose vaccination
Immunogenicity indicator
Time frame: 10,20,and 30 days
The seropositive rate of EV71 neutralizing antibody 10, 20, 30, and 60 days after the first dose vaccination
Immunogenicity indicator
Time frame: 10, 20,30,and 60 days
GMT and GMT increase fold of EV71 neutralizing antibody 10,20,30,and 60 days after the first dose vaccination
Immunogenicity indicator
Time frame: 10,20，30，and 60 days
Incidence of unsolicited local or systemic adverse events within 3 days after each dose
Safety indicator
Time frame: 3 days
Incidence of unsolicited adverse events within 30 days after each dose
Safety indicator
Time frame: 30 days
Incidence of the serious adverse events within 60 days after the first dose vaccination
Safety indicator
Time frame: 60 days
Ran from Jul 2017 to primary completion in Sep 2017, 1 month.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Enterovirus 71 vaccine
Hand, Foot and Mouth Disease →