A Phase 3 interventional study of Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) and Placebo in Hand, Foot, and Mouth Disease(HFMD) and Herpangina, sponsored by Sinovac Biotech Co., Ltd. Not yet recruiting at 5 sites in China. Open to participants aged 6 Months to 71 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Sinovac Biotech Co., Ltd · Phase 3, Interventional, and Prevention
This multicenter, randomized, double-blind, placebo-controlled phase IIIa clinical trial aims to evaluate the protective efficacy , immunogenicity and safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) in Children aged 6 to 71 months.
Participants will be randomly assigned in a 1:1 ratio to the trial group and the placebo group, receiving two doses of experimental vaccine or placebo , with a one-month interval between the two doses.
This trial employs a multicenter, randomized, double-blind, placebo-controlled design.With informed consent, 6000 children participants aged 6 to 71 months will be enrolled, with 2800 participants aged 6 to 23 months and 3200 participants aged 24 to 71 months, maintaining a balanced gender ratio. All participants will be randomly assigned to the trial and placebo groups at a 1:1 ratio, receiving two doses of experimental vaccine or placebo , with a one-month interval between the two doses.
Protective Efficacy Assessment: Each participant enters the case monitoring period after receiving the first dose of vaccination, which lasts until the end of two consecutive hand, foot and mouth disease (HFMD) epidemic seasons (i.e., the peak incidence period; bimodal epidemics occurring within the same year shall be regarded as one single epidemic season).
The valid case monitoring period commences on Day 15 after the second dose, and the period prior thereto is defined as the surveillance window period. During case monitoring , suspected cases identified through active follow-up by investigators or spontaneous reports from participants' guardians shall be subjected to nucleic acid testing using pharyngeal swabs and/or anal swabs collected once within 3 days after the initial onset of symptoms, with subsequent follow-up and specimen sampling conducted according to test results.
Safety Assessment: Adverse events (AEs) occurring within 30 minutes after each vaccination shall be collected from all participants. Serious adverse events (SAEs) will be monitored from the first dose administration until 6 months after the last dose, with SAE follow-up visits conducted once monthly. All AEs identified via spontaneous reports from participants' guardians or any other sources from the first dose up to 30 days after the last dose will be closely monitored, truthfully recorded and included in the analysis.
A total of 3000 participants will be enrolled in the reactogenicity subgroup, including 1400 children aged 6-23 months and 1600 children aged 24-71 months. On the basis of the above safety observations, participants in the reactogenicity subgroup shall record solicited and unsolicited AEs within 0 to 7 days after each vaccination using diary cards, and collect AEs occurring from Day 8 to Day 30 after each vaccination via contact cards.
Humoral Immunogenicity Assessment: A total of 600 participants will be selected from the reactogenicity subgroup into the humoral immunogenicity subgroup, consisting of 280 children aged 6-23 months and 320 children aged 24-71 months. Venous blood samples of 3.0 (±0.5) mL will be collected from participants in this subgroup at baseline before the first dose, 30 days, 6 months and 12 months after the second dose respectively. Sera isolated at the above four time points will be tested for neutralizing antibodies against EV71, CA16, CA10 and CA6 to evaluate immunogenicity and immune persistence. Sera collected before the first dose and 30 days after the second dose will be used to detect neutralizing antibodies against different enterovirus subtypes so as to explore cross-protective capacity. Meanwhile, 60 participants aged less than 12 months from this subgroup will receive all vaccinations at the anterolateral thigh, while the remaining participants will be vaccinated via the deltoid muscle of the upper arm, to analyze the differences in immunogenicity and immune persistence between different vaccination sites.
Cellular Immunogenicity Assessment:Another 80 participants aged 24-71 months will be enrolled from the reactogenicity subgroup into the cellular immunogenicity subgroup. Venous blood samples of 3.0 (±0.5) mL will be collected before each vaccination and on Day 14 after each dose administration. Blood samples from the first 40 randomly numbered participants will be used to detect the expression levels of EV71 and CA16-specific IFN-γ and IL-4 in T cells, and samples from the latter 40 randomly numbered participants will be applied to measure T cell expression levels of CA10 and CA6-specific IFN-γ and IL-4.
The primary protective efficacy analysis will be conducted when case monitoring for at least one epidemic season is completed, the total number of hand, foot and mouth disease cases caused by any serotype of EV71, CA16, CA10 and CA6 identified during the valid case surveillance period reaches no less than 73, and the number of HFMD cases induced by CA16 and CA6 infection reaches no less than 38 respectively.
59 studies on the registry are indexed under Hand, Foot and Mouth Disease; 10 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 467 across 50 interventional studies indexed under Hand, Foot and Mouth Disease.
Browse Hand, Foot and Mouth Disease studies →Sinovac Biotech Co., Ltd is the lead sponsor of 93 studies on the registry; 19 are open to participants now.
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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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
3000 participants aged 6-71 months will receive Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.
Biological: Tetravalent Inactivated Enterovirus Vaccine (Vero Cell)
3000 participants aged 6-71 months will receive placebo .Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.
Biological: Placebo
Two doses are administered with a one-month interval between each dose.
Two doses are administered with a one-month interval between each dose.
Evaluate the protective efficacy of the investigational vaccine against HFMD caused by any serotype of EV71, CA16, CA10 and CA6 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed primary HFMD caused by any serotype of EV71, CA16, CA10 and CA6 in children aged 6 to 71 months starting from Day 15 after full-course vaccination during the primary protective efficacy analysis stage.
Time frame: From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)
Evaluate the protective efficacy of the investigational vaccine against HFMD caused by CA6 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed primary HFMD caused by CA6 in children aged 6 to 71 months starting from Day 15 after full-course vaccination during the primary protective efficacy analysis stage.
Time frame: From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)From day 15 after the full-course vaccination to data cutoff date of primary analysis
Evaluate the protective efficacy of the investigational vaccine against HFMD caused by CA16 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed primary HFMD caused by CA16 in children aged 6 to 71 months starting from Day 15 after full-course immunization during the primary protective efficacy analysis stage.
Time frame: From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)
Evaluate the safety of the investigational vaccine
Incidence of adverse reactions within 0-30 days after each dose of investigational vaccine
Time frame: From day 0 to day 30 after vaccination (The day of vaccination is defined as Day 0)
Evaluate the safety of the investigational vaccine
Incidence of serious adverse events (SAEs) from the start of vaccination until 6 months after the full vaccination.
Time frame: From day of vaccination to 6 months after vaccination
Evaluate the seroconversion rate of neutralizing antibodies against EV71, CA16, CA10, CA6
Assess the seroconversion rate of neutralizing antibodies against EV71, CA16, CA10, CA6 at day 30 after full-course vaccination
Time frame: At day 30 after full-course vaccination
Evaluate the seropositivity rate of neutralizing antibodies against EV71, CA16, CA10, CA6
Assess the seropositivity rate of neutralizing antibodies against EV71, CA16, CA10, CA6 at day 30 after full-course vaccination
Time frame: At day 30 after full-course vaccination
Evaluate the GMT of neutralizing antibodies against EV71, CA16, CA10, CA6
Assess the GMT of neutralizing antibodies against EV71, CA16, CA10, CA6 at 30 days after full-course vaccination
Time frame: At day 30 after full-course vaccination
Evaluate the GMI of neutralizing antibodies against EV71, CA16, CA10, CA6
Assess the GMI of neutralizing antibodies against EV71, CA16, CA10, CA6 at 30 days after full-course vaccination
Time frame: At day 30 after full-course vaccination
Evaluate the seroconversion rate of neutralizing antibodies against EV71, CA16, CA10, CA6
Assess the seroconversion rate of neutralizing antibodies against EV71, CA16, CA10, CA6 at 6 months after full-course vaccination
Time frame: At 6 months after full-course vaccinaton
Evaluate the seroconversion rate of neutralizing antibodies against EV71, CA16, CA10, CA6
Assess the seroconversion rate of neutralizing antibodies against EV71, CA16, CA10, CA6 at 12 months after full-course vaccination
Time frame: At 12 months after full-course vaccinaton
Evaluate the seropositivity rate of neutralizing antibodies against EV71, CA16, CA10, CA6
Assess the seropositivity rate of neutralizing antibodies against EV71, CA16, CA10, CA6 at 6 months after full-course vaccination
Time frame: At 6 months after full-course vaccination
Evaluate the seropositivity rate of neutralizing antibodies against EV71, CA16, CA10, CA6
Assess the seropositivity rate of neutralizing antibodies against EV71, CA16, CA10, CA6 at 12 months after full-course vaccination
Time frame: At 12 months after full-course vaccination
Evaluate the GMT of neutralizing antibodies against EV71, CA16, CA10, CA6
Assess the GMT of neutralizing antibodies against EV71, CA16, CA10, CA6 at 6 months after full-course vaccination
Time frame: At 6 months after full-course vaccination
Evaluate the GMT of neutralizing antibodies against EV71, CA16, CA10, CA6
Assess the GMT of neutralizing antibodies against EV71, CA16, CA10, CA6 at 12 months after full-course vaccination
Time frame: At 12 months after full-course vaccination
Evaluate the GMI of neutralizing antibodies against EV71, CA16, CA10, CA6
Assess the GMI of neutralizing antibodies against EV71, CA16, CA10, CA6 at 6 months after full-course vaccination
Time frame: At 6 months after full-course vaccination
Evaluate the GMI of neutralizing antibodies against EV71, CA16, CA10, CA6
Assess the GMI of neutralizing antibodies against EV71, CA16, CA10, CA6 at 12 months after full-course vaccination
Time frame: At 12 months after full-course vaccination
Evaluate the protective efficacy of the investigational vaccine against diseases caused by any serotype of EV71, CA16, CA10 and CA6 infection compared to placebo.
The protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed diseases caused by any serotype of EV71, CA16, CA10 and CA6 in children aged 6 to 71 months starting from Day 15 after full-course immunization during the primary protective efficacy analysis stage.
Time frame: From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)
Evaluate the protective efficacy of the investigational vaccine against severe cases caused by any serotype of EV71, CA16, CA10 and CA6 infection compared to placebo.
The protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed severe cases caused by any serotype of EV71, CA16, CA10 and CA6 in children aged 6 to 71 months starting from Day 15 after full-course immunization during the primary protective efficacy analysis stage.
Time frame: From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)
Evaluate the protective efficacy of the investigational vaccine against hospitalized cases caused by any serotype of EV71, CA16, CA10 and CA6 infection compared to placebo.
The protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed hospitalized cases caused by any serotype of EV71, CA16, CA10 and CA6 in children aged 6 to 71 months starting from Day 15 after full-course immunization during the primary protective efficacy analysis stage.
Time frame: From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)
Evaluate the protective efficacy of the investigational vaccine against HFMD caused by any serotype of EV71, CA16, CA10 and CA6 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed HFMD caused by any serotype of EV71, CA16, CA10 and CA6 in children aged 6 to 71 months, from Day 15 after full-course immunization until the end of two consecutive epidemic seasons.
Time frame: From day 15 after full-course vaccination to the end of case surveillance period (December 31, 2027)
Evaluate the protective efficacy of the investigational vaccine against herpangina caused by any serotype of EV71, CA16, CA10 and CA6 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed herpangina caused by any serotype of EV71, CA16, CA10 and CA6 in children aged 6 to 71 months, from Day 15 after full-course immunization until the end of two consecutive epidemic seasons.
Time frame: From day 15 after full-course vaccination to the end of case surveillance period (December 31, 2027)
Evaluate the protective efficacy of the investigational vaccine against diseases caused by any serotype of EV71, CA16, CA10 and CA6 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed diseases caused by any serotype of EV71, CA16, CA10 and CA6 in children aged 6 to 71 months, from Day 15 after full-course immunization until the end of two consecutive epidemic seasons.
Time frame: From day 15 after full-course vaccination to the end of case surveillance period (December 31, 2027)
Evaluate the protective efficacy of the investigational vaccine against severe cases caused by any serotype of EV71, CA16, CA10 and CA6 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed severe cases caused by any serotype of EV71, CA16, CA10 and CA6 in children aged 6 to 71 months, from Day 15 after full-course immunization until the end of two consecutive epidemic seasons.
Time frame: From day 15 after full-course vaccination to the end of case surveillance period (December 31, 2027)
Evaluate the protective efficacy of the investigational vaccine against hospitalized cases caused by any serotype of EV71, CA16, CA10 and CA6 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed hospitalized cases caused by any serotype of EV71, CA16, CA10 and CA6 in children aged 6 to 71 months, from Day 15 after full-course immunization until the end of two consecutive epidemic seasons.
Time frame: From day 15 after full-course vaccination to the end of case surveillance period (December 31, 2027)
Evaluate the protective efficacy of the investigational vaccine versus placebo against HFMD caused by EV71 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed HFMD caused by EV71 infection in children aged 6 to 71 months, from Day 15 after full-course immunization until the end of two consecutive epidemic seasons.
Time frame: From day 15 after full-course vaccination to the end of case surveillance period (December 31, 2027)
Evaluate the protective efficacy of the investigational vaccine versus placebo against HFMD caused by CA10 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed HFMD caused by CA10 infection in children aged 6 to 71 months, from Day 15 after full-course immunization until the end of two consecutive epidemic seasons.
Time frame: From day 15 after full-course vaccination to the end of case surveillance period (December 31, 2027)
Evaluate the protective efficacy of the investigational vaccine versus placebo against HFMD caused by CA16 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed HFMD caused by CA16 infection in children aged 6 to 71 months, from Day 15 after full-course immunization until the end of two consecutive epidemic seasons.
Time frame: From day 15 after full-course vaccination to the end of case surveillance period (December 31, 2027)
Evaluate the protective efficacy of the investigational vaccine versus placebo against HFMD caused by CA6 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed HFMD caused by CA6 infection in children aged 6 to 71 months, from Day 15 after full-course immunization until the end of two consecutive epidemic seasons.
Time frame: From day 15 after full-course vaccination to the end of case surveillance period (December 31, 2027)
Evaluate the protective efficacy of the investigational vaccine compared to placebo against diseases caused by infections with other untyped enteroviruses excluding EV71, CA16, CA10 and CA6 .
Evaluate the protective efficacy of the investigational vaccine compared to placebo against RT-PCR-confirmed diseases caused by infections with other untyped enteroviruses excluding EV71, CA16, CA10 and CA6 in children aged 6 to 71 months, from Day 15 after full-course immunization until the end of two consecutive epidemic seasons.
Time frame: From day 15 after full-course vaccination to the end of case surveillance period (December 31, 2027)
Evaluate the seroconversion rate of neutralizing antibodies against different subtype strains
Assess the seroconversion rate of neutralizing antibodies against different subtype strains at 30 days after full-course vaccination
Time frame: Day 30 after full-course vaccination
Evaluate the seropositivity rate of neutralizing antibodies against different subtype strains
Assess the seropositivity rate of neutralizing antibodies against different subtype strains at 30 days after full-course vaccination
Time frame: Day 30 after full-course vaccination
Evaluate the GMT of neutralizing antibodies against different subtype strains
Assess the GMT of neutralizing antibodies against different subtype strains at 30 days after full-course vaccination
Time frame: Day 30 after full-course vaccination
Evaluate the GMI of neutralizing antibodies against different subtype strains
Assess the GMI of neutralizing antibodies against different subtype strains at 30 days after full-course vaccination
Time frame: Day 30 after full-course vaccination
Evaluate the cellular immunity induced by the investigational vaccine
Measure the number of EV71, CA16, CA10 and CA6-specific IFN-γ and IL-4 spot-forming cells per 3×10\^6 peripheral blood mononuclear cells (PBMCs) from participants aged 24 to 71 months , before each immunization and on the 14th day after each vaccination.
Time frame: Pre-vaccination on each dosing day; day 14 after each dose
Evaluate the cellular immunity induced by the investigational vaccine
Evaluate the Fold increase from baseline in EV71, CA16, CA10 and CA6-specific IFN-γ and IL-4 spot-forming cell counts per 3×10\^6 PBMCs among children aged 24 to 71 months at day 14 after the first dose, before the second dose, and at day 14 after the second dose.
Time frame: Pre-vaccination on each dosing day; day 14 after each dose
Start is estimated for May 2026; primary completion for Dec 2027, 19 months later.
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Hand, Foot and Mouth Disease →