Hand, Foot, and Mouth Disease (HFMD)NCT07793175
Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children
A study testing EV71 vaccine in people with Hand, Foot, and Mouth Disease (HFMD) and Enterovirus 71 Infection, run by Sinovac Biotech Co., Ltd at 1 site in Vietnam.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of an inactivated Enterovirus Type 71 (EV71) vaccine, manufactured by Sinovac, in healthy Vietnamese children aged 6 to 71 months. Read more about this study
- Who is it for?
- Ages 6 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Hand, Foot, and Mouth Disease (HFMD), Enterovirus 71 Infection
- What is being tested?
- EV71 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteVietnam
- Study dates
- 19 Sep 2026to 16 Jul 2027
- Phase
- Interventional
- 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 6 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 6~71 months when receiving the first dose of investigational EV71 vaccine;
- Participants' legal guardians are able to understand and sign the informed consent voluntarily;
- Participants are able to comply with the study procedures based on the assessment of the investigator;
- Participants should provide verifiable identification, be reachable by the investigator and must be able to contact the investigator throughout the study period.
Who cannot join
- Prior history of hand, foot and mouth disease (HFMD);
- Have been exposed to a case with laboratory-confirmed (virological diagnosis, e.g., via PCR or virus isolation) HFMD at home, day care, or other settings within 2 weeks before enrollment;
- Prior participated in clinical trial of EV71 vaccine and received any investigational EV71 vaccine;
- Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- Any known or history of autoimmune diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, etc.) or immunodeficiency/immunosuppression (such as HIV infection, organ transplantation), asplenia;
- Received immunosuppressive for ≥14 days (e.g., prednisone equivalent of ≥2 mg/kg), or cytotoxic drug before enrollment, or plans to receive these treatments during the study participation.
Show all 13Show fewer
- Receipt of blood products or immunoglobulins within the past 3 months before enrollment in this study, or scheduled to receive these treatments during the study period;
- Receipt of other investigational vaccines within 30 days prior to vaccination in this study;
- Receipt of other vaccines within 14 days prior to vaccination in this study;
- Presence of any acute disease (moderate to severe illness, with or without fever) or an acute exacerbation of a chronic condition within the 7 days prior to vaccination in this study.
- Has fever on the day of vaccination, with the axillary temperature ≥ 37.5 celsius before vaccination;
- Is participating in or planning to participate in other vaccine or drug clinical trials;
- According to the investigator's judgment, the participant has any other factors that might interfere with the clinical trial results or pose additional risk to the participant due to participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Pasteur Institute
Ho Chi Minh City
Luong Chan Quang, M.D., (84-28) 38230352, pasteur@pasteurhcm.edu.vn
About this study
Official title: Immunogenicity and Safety of Enterovirus Type 71 Vaccine, Inactivated in Healthy Children Aged 6~71 Months: A Single-armed Bridging Clinical Trial
The purpose of this study is to evaluate the immunogenicity and safety of an inactivated Enterovirus Type 71 (EV71) vaccine, manufactured by Sinovac, in healthy Vietnamese children aged 6 to 71 months.
Hand, Foot, and Mouth Disease (HFMD) is a common infectious disease in children, and EV71 is a major cause of severe complications and outbreaks in the Asia-Pacific region, including Vietnam. While this vaccine has demonstrated high efficacy and a favorable safety profile in previous clinical trials conducted in China, this study aims to generate specific bridging data for the Vietnamese pediatric population.
This is a single-armed bridging clinical trial that plans to enroll approximately 320 healthy participants. Each participant will receive two doses of the EV71 vaccine administered intramuscularly on a 0 and 30-day schedule. The primary objective is to assess the seroconversion rate of neutralizing antibodies 30 days after the second dose. Safety will be assessed by monitoring the incidence of adverse reactions and serious adverse events (SAEs) throughout the study duration (approximately 2 months).
- Being tested
- EV71 vaccine
- 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.
EV71 vaccineBiological
Inactivated Enterovirus Type 71 Vaccine (Vero Cell), 0.5 mL per dose. Each dose contains no less than 3.0 EU of inactivated EV71 antigen adsorbed onto aluminum hydroxide. The vaccine is supplied as a milky white suspension in a pre-filled syringe. Participants will receive two intramuscular (IM) injections into the deltoid region of the upper arm, administered on a 0 and 30-day schedule.
| Study group | Role | What they receive |
|---|---|---|
| EV71 Vaccine Group | Experimental | All participants will receive two intramuscular doses of the inactivated Enterovirus Type 71 (EV71) vaccine (0.5 mL per dose) on a 0 and 30-day schedule. Receives: Biological: EV71 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate of Enterovirus Type 71 (EV71) neutralizing antibodies
Seroconversion is defined as: (1) a post-vaccination neutralizing antibody titer of ≥ 1:8 in participants with a pre-vaccination titer of < 1:8; or (2) at least a four-fold increase in neutralizing antibody titer in participants with a pre-vaccination titer of ≥ 1:8.
Measured: 30 days after the second dose of vaccination
Secondary outcomes (6)
Seropositive rate of Enterovirus Type 71 (EV71) neutralizing antibodies
The percentage of participants with a neutralizing antibody titer ≥ 1:8 against EV71.
Measured: 30 days after the second dose of vaccination
GMT of Enterovirus Type 71 (EV71) neutralizing antibodies
The geometric mean of neutralizing antibody titers against EV71.
Measured: 30 days after the second dose of vaccination
GMFR of Enterovirus Type 71 (EV71) neutralizing antibodies
The geometric mean of the ratio of post-vaccination neutralizing antibody titer to pre-vaccination titer.
Measured: 30 days after the second dose of vaccination
Incidence of adverse reactions within 30 days
Incidence of adverse reactions within 30 days after each dose vaccination.
Measured: 30 days after each dose vaccination
Incidence of adverse reactions within 7 days
Incidence of adverse reactions within 7 days after each dose vaccination.
Measured: 7 days after each dose vaccination
Incidence of SAE
Incidence of serious adverse events (SAE) from the first dose vaccination until 30 days after the second dose vaccination.
Measured: From the first dose vaccination until 30 days after the second dose vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start19 Sep 2026 (estimated)
- Primary completion9 Jan 2027 (estimated)
- Study completion16 Jul 2027 (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 Disease (HFMD)Studies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793175
- Sponsor's protocol ID
- PRO-EV71-4016
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Enterovirus Type 71 Vaccine, Inactivated in Healthy Children Aged 6~71 Months: A Single-armed Bridging Clinical Trial
- ClinicalTrials.gov ID
- NCT07793175
- Acronym / sponsor ID
- PRO-EV71-4016
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2026 (estimated)
- Primary completion
- 9 Jan 2027 (estimated)
- Study completion
- 16 Jul 2027 (estimated)
- First posted
- 28 Aug 2026 (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.
The purpose of this study is to evaluate the immunogenicity and safety of an inactivated Enterovirus Type 71 (EV71) vaccine, manufactured by Sinovac, in healthy Vietnamese children aged 6 to 71 months.
Hand, Foot, and Mouth Disease (HFMD) is a common infectious disease in children, and EV71 is a major cause of severe complications and outbreaks in the Asia-Pacific region, including Vietnam. While this vaccine has demonstrated high efficacy and a favorable safety profile in previous clinical trials conducted in China, this study aims to generate specific bridging data for the Vietnamese pediatric population.
This is a single-armed bridging clinical trial that plans to enroll approximately 320 healthy participants. Each participant will receive two doses of the EV71 vaccine administered intramuscularly on a 0 and 30-day schedule. The primary objective is to assess the seroconversion rate of neutralizing antibodies 30 days after the second dose. Safety will be assessed by monitoring the incidence of adverse reactions and serious adverse events (SAEs) throughout the study duration (approximately 2 months).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EV71 Vaccine Group | Experimental | Biological: EV71 vaccineAll participants will receive two intramuscular doses of the inactivated Enterovirus Type 71 (EV71) vaccine (0.5 mL per dose) on a 0 and 30-day schedule. |
Who may qualify
- Ages
- 6 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children aged 6~71 months when receiving the first dose of investigational EV71 vaccine;
- Participants' legal guardians are able to understand and sign the informed consent voluntarily;
- Participants are able to comply with the study procedures based on the assessment of the investigator;
- Participants should provide verifiable identification, be reachable by the investigator and must be able to contact the investigator throughout the study period.
Key exclusion criteria (13 listed)
- Prior history of hand, foot and mouth disease (HFMD);
- Have been exposed to a case with laboratory-confirmed (virological diagnosis, e.g., via PCR or virus isolation) HFMD at home, day care, or other settings within 2 weeks before enrollment;
- Prior participated in clinical trial of EV71 vaccine and received any investigational EV71 vaccine;
- Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- Any known or history of autoimmune diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, etc.) or immunodeficiency/immunosuppression (such as HIV infection, organ transplantation), asplenia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EV71 vaccineInactivated Enterovirus Type 71 Vaccine (Vero Cell), 0.5 mL per dose. Each dose contains no less than 3.0 EU of inactivated EV71 antigen adsorbed onto aluminum hydroxide. The vaccine is supplied as a milky white suspension in a pre-filled syringe. Participants will receive two intramuscular (IM) injections into the deltoid region of the upper arm, administered on a 0 and 30-day schedule. | Biological | EV71 Vaccine Group |
Primary outcome
Seroconversion rate of Enterovirus Type 71 (EV71) neutralizing antibodies
Time frame: 30 days after the second dose of vaccination
Seroconversion is defined as: (1) a post-vaccination neutralizing antibody titer of ≥ 1:8 in participants with a pre-vaccination titer of < 1:8; or (2) at least a four-fold increase in neutralizing antibody titer in participants with a pre-vaccination titer of ≥ 1:8.
6 secondary outcomes
Seropositive rate of Enterovirus Type 71 (EV71) neutralizing antibodies
Time frame: 30 days after the second dose of vaccination
GMT of Enterovirus Type 71 (EV71) neutralizing antibodies
Time frame: 30 days after the second dose of vaccination
GMFR of Enterovirus Type 71 (EV71) neutralizing antibodies
Time frame: 30 days after the second dose of vaccination
Incidence of adverse reactions within 30 days
Time frame: 30 days after each dose vaccination
Incidence of adverse reactions within 7 days
Time frame: 7 days after each dose vaccination
Incidence of SAE
Time frame: From the first dose vaccination until 30 days after the second dose vaccination
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 1 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Hand, Foot, and Mouth Disease (HFMD)
Not yet recruiting
CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu
Hand, Foot and Mouth Disease, Infection Control
Not yet recruitingPhase 3
Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
Hand, Foot, and Mouth Disease(HFMD), Herpangina
Not yet recruitingPhase 1
Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine
Hand, Foot and Mouth Disease (HFMD), HFMD
Enrolling by invitationObservational study
Study on the Persistence of Immunity Following EV71 Vaccination
Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD)
Recruiting
Clinical Trial of Pegylated Interferon α-2b Via Nebulization for Treatment of Hand, Foot, and Mouth Disease .
HFMD
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EV71 vaccine in people with Hand, Foot, and Mouth Disease (HFMD) and Enterovirus 71 Infection, run by Sinovac Biotech Co., Ltd at 1 site in Vietnam.
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 4 inclusion and 13 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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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?
Contact Luong Chan Quang, M.D. ((84-28) 38230352, pasteur@pasteurhcm.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate of Enterovirus Type 71 (EV71) neutralizing antibodies (time frame: 30 days after the second dose of vaccination). 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 1 Sep 2026.