This multicenter, randomized, double-blind, controlled Phase III clinical trial aims to evaluate the efficacy, safety, and immunogenicity of the bivalent enterovirus-inactivated vaccine (Vero cell) in healthy children aged 6 to 71 months.
The main questions it aims to answer are:
* The primary vaccine efficacy of the investigational vaccine against Hand, Foot, and Mouth Disease（HFMD) caused by CA16 infection compared to the control vaccine. * The neutralizing antibody levels against EV71 in the trial group are non-inferior to those in the control group after two doses of vaccination.
Researchers will compare the bivalent enterovirus-inactivated vaccine (Vero cell) to the EV71-inactivated vaccine (Vero cell) to prevent HFMD and Herpangina(HA).
Participants will be randomly assigned to the trial group and the control group in a 1:1 ratio to receive two doses of the investigational vaccine or the control EV71 vaccine, with a one-month interval between doses.
Healthy children aged 6 to 71 months with no history of EV71 vaccination; or healthy children aged 24 to 71 months who have completed two doses of EV71 vaccine at least 6 months prior.
Guardians who can understand and voluntarily sign the informed consent form.
Willing and able to comply with all visit schedules, sample collections, vaccinations, and other research procedures.
Provide proof of identity documents.
A known history of HFMD/HA.
Uncontrolled chronic diseases or a history of severe illnesses, including but not limited to cardiovascular diseases, blood disorders, liver or kidney diseases, digestive system diseases, respiratory system diseases, malignant tumors, or a history of major functional organ transplantation.
Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection).
Abnormal coagulation function (such as coagulation factor deficiencies, and platelet abnormalities).
Parallel
bivalent enterovirus vaccine (Vero cell), inactivated
Biological/VaccineTwo doses are administered with a one-month interval between each dose.
Enterovirus Type 71 Vaccine (Vero Cell), Inactivated
Biological/VaccineTwo doses are administered with a one-month interval between each dose.
Evaluate the primary vaccine efficacy of the trial vaccine against HFMD caused by CA16 infection compared to the control vaccine.
Evaluate the primary vaccine efficacy of the trial vaccine against HFMD caused by CA16 infection, diagnosed by RT-PCR, in children aged 6 to 71 months (with and without a history of EV71 vaccination) 14 days after full vaccination (based on data from at least 47 cases). The vaccine's efficacy will be evaluated by monitoring the annual incidence rate of HFMD attributable to CA16 infection, as confirmed by reverse transcription polymerase chain reaction (RT-PCR) nucleic acid testing, following complete full immunization for 14 days based on data from at least 47 cases until the end of one epidemic seasons.
Evaluate whether the neutralizing antibody levels against EV71 in the trial group are non-inferior to those in the control group after two doses of vaccination.
Evaluate the seroconversion rate and geometric mean titer (GMT) of EV71 neutralizing antibodies in participants aged 6-71 months without a history of EV71 vaccination and negative for EV71 antibodies before immunization, 30 days after full vaccination.
Evaluate the safety of the trial vaccine.
1. Monitor the incidence of adverse events (AEs) within 0-30 days after each dose of the trial vaccine. 2. Monitor the incidence of adverse reacts (ARs) within 0-30 days after each dose of the trial vaccine. 3. Monitor the incidence of serious adverse events (SAEs) from the start of vaccination until 6 months after the full vaccination.
Evaluate the long-term vaccine efficacy of the trial vaccine compared to the control vaccine against HFMD caused by CA16 infection
Evaluate the vaccine efficacy against CA16 infection-induced HFMD, confirmed by RT-PCR, in the entire population (including those with and without a history of EV71 vaccination) from 14 days after full immunization until the end of two consecutive epidemic seasons. The vaccine's efficacy will be evaluated by monitoring the annual incidence rate of HFMD attributable to CA16 infection, as confirmed by reverse transcription polymerase chain reaction (RT-PCR) nucleic acid testing, following complete full immunization for 14 days until the end of two epidemic seasons.
Evaluate the long-term vaccine efficacy of the trial vaccine compared to the control vaccine against Herpangina(HA) caused by CA16 infection
Evaluate the vaccine efficacy against HA caused by CA16 infection, confirmed by RT-PCR, in the entire population (including those with and without a history of EV71 vaccination) from 14 days after full immunization until the end of two consecutive epidemic seasons. The vaccine's efficacy will be evaluated by monitoring the annual incidence rate of HA attributable to CA16 infection, as confirmed by reverse transcription polymerase chain reaction (RT-PCR) nucleic acid testing, following complete full immunization for 14 days until the end of two epidemic seasons.
Evaluate the seroconversion rate of the neutralizing antibodies against CA16 and EV71 in populations without a history of EV71 vaccination.
On the 30th day after full vaccination, assess the seroconversion rate of neutralizing antibodies against CA16 and EV71 in populations without a history of EV71 vaccination.
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