Hand, Foot, and Mouth DiseaseNCT07144202
Study on the Persistence of Immunity Following EV71 Vaccination
An observational study of Hand, Foot, and Mouth Disease and Hand, Foot, and Mouth Disease (HFMD), run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 4 sites in China.
Trial summary
This is a thirteen-year follow-up study conducted as an extension of a Phase III clinical trial. In this study, a sub-cohort of volunteers who was eligible for enrollment and randomly administrated either 2 dose EV71 vaccine or placebo in the phase III clinical trial was selected to evaluate the EV71 immune levels 13… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD)
- Type of treatment
- Vaccines
- How many people
- 270 participants
- Where
- 4 sitesChina
- Study dates
- 10 Aug 2025to 10 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Immunogenicity group participants from the phase III clinical trial
Who may be able to join
- Included in the immunogenicity group of initial studyand randomly into either vaccine (fulfilled the two doses vaccination following the protocol) or placebo group.
- Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the study's requirements.
Who cannot join
- Had history of extra EV71 vaccination.
- Previous history of hand-foot-mouth disease.
- Participating in other research.
- Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders.
- Investigators' Discretion: The final exclusion criterion is the discretion of investigators to determine whether a subject is suitable for participation in the study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Lingchuan Center for Disease Control and Prevention
Guilin, Guangxi
Lipu Center for Disease Control and Prevention
Guilin, Guangxi
Xing'an Center for Disease Control and Prevention
Guilin, Guangxi
Yongfu Center for Disease Control and Prevention
Guilin, Guangxi
About this study
Official title: Study on the Immunity Persistence Following Immunization With Enterovirus Type 71 Vaccine, Inactivated (Human Diploid Cell)
This is a thirteen-year follow-up study conducted as an extension of a Phase III clinical trial. In this study, a sub-cohort of volunteers who was eligible for enrollment and randomly administrated either 2 dose EV71 vaccine or placebo in the phase III clinical trial was selected to evaluate the EV71 immune levels 13 years after the primary vaccination.
Read the detailed description
The initial study was a randomized, double-blind, placebo-controlled phase III clinical trial conducted in children aged 6-71 months from Guilin region of Guangxi Province in 2012. A total of 12000 participants (with 1100 in the immunogenicity group) were randomized in a 1:1 ratio to receive two doses EV71 vaccine or placebo on a 0-, 28-day schedule. Besides, an extended one-year and two year follow-up of this study was completed in 2013.
In this study, immunogenicity group participants from the phase III clinical trial was chosen as the studied subjects. A retrospective survey for the enrolled subjects involved with the history of HFMD and the extra vaccination of EV71 vaccine was conducted before blood collection. 3 ml venous blood were collected from each available subject for EV71 neutralizing antibody (NAb) testing. Since the unblinding was performed after the initial study completed, this study was an open-labelled detection for the persistence of the vaccine-induced EV71 NAb.
- Medical subject headings
- Hand, Foot and Mouth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Two doses of placebo at the vaccination schedule of Day 0, 28 | |
| Vaccine | EV71 vaccine on Day 0, 28 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Year 13 after the second vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method
Measured: Year 13 after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start10 Aug 2025
- Primary completion25 Aug 2025 (estimated)
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand, Foot, and Mouth DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teng Huang, Principal investigator, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144202
- Sponsor's protocol ID
- EV71-402
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Immunity Persistence Following Immunization With Enterovirus Type 71 Vaccine, Inactivated (Human Diploid Cell)
- ClinicalTrials.gov ID
- NCT07144202
- Acronym / sponsor ID
- EV71-402
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a thirteen-year follow-up study conducted as an extension of a Phase III clinical trial. In this study, a sub-cohort of volunteers who was eligible for enrollment and randomly administrated either 2 dose EV71 vaccine or placebo in the phase III clinical trial was selected to evaluate the EV71 immune levels 13 years after the primary vaccination.
Detailed description
The initial study was a randomized, double-blind, placebo-controlled phase III clinical trial conducted in children aged 6-71 months from Guilin region of Guangxi Province in 2012. A total of 12000 participants (with 1100 in the immunogenicity group) were randomized in a 1:1 ratio to receive two doses EV71 vaccine or placebo on a 0-, 28-day schedule. Besides, an extended one-year and two year follow-up of this study was completed in 2013.
In this study, immunogenicity group participants from the phase III clinical trial was chosen as the studied subjects. A retrospective survey for the enrolled subjects involved with the history of HFMD and the extra vaccination of EV71 vaccine was conducted before blood collection. 3 ml venous blood were collected from each available subject for EV71 neutralizing antibody (NAb) testing. Since the unblinding was performed after the initial study completed, this study was an open-labelled detection for the persistence of the vaccine-induced EV71 NAb.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | – | –Two doses of placebo at the vaccination schedule of Day 0, 28 |
| Vaccine | – | –EV71 vaccine on Day 0, 28 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Immunogenicity group participants from the phase III clinical trial
Key inclusion criteria (3 listed)
- Included in the immunogenicity group of initial studyand randomly into either vaccine (fulfilled the two doses vaccination following the protocol) or placebo group.
- Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the study's requirements.
Key exclusion criteria (5 listed)
- Had history of extra EV71 vaccination.
- Previous history of hand-foot-mouth disease.
- Participating in other research.
- Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders.
- Investigators' Discretion: The final exclusion criterion is the discretion of investigators to determine whether a subject is suitable for participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immunogenicity index-seropositive rates of neutralizing antibody
Time frame: Year 13 after the second vaccination
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
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Time frame: Year 13 after the second vaccination
Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teng Huang principal investigator
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand, Foot, and Mouth Disease and Hand, Foot, and Mouth Disease (HFMD), run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity index-seropositive rates of neutralizing antibody (time frame: Year 13 after the second vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.