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Also known as bivalent enterovirus vaccine (Vero cell), inactivated, bivalent enterovirus vaccine, inactivated
low dose Bivalent Enterovirus Vaccine, Inactivated · 2 trials · 3 indications
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 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.
the incidence rates of adverse reactions from the start of vaccination to 30 days after the end of the entire vaccination course
The seroconversion rate of EV71 and CA16 neutralizing antibodies in children aged 6-71 months 30 days after the end of the entire vaccination course.
| Arm | Type | Description |
|---|---|---|
| trial group | EXPERIMENTAL | Bivalent enterovirus inactivated vaccine (Vero cell) |
| control group | ACTIVE_COMPARATOR | Enterovirus Type 71 Vaccine (Vero Cell), Inactivated |
| low-dose experimental group | EXPERIMENTAL | phase Ⅰ: 18\~59 years old,6\~12 years old,6\~71 months old; phase Ⅱ：6\~71 months old |
| medium-dose experimental group | EXPERIMENTAL | phase Ⅰ: 18\~59 years old,6\~12 years old,6\~71 months old; phase Ⅱ：6\~71 months old |
| high-dose experimental group | EXPERIMENTAL | phase Ⅰ: 18\~59 years old,6\~12 years old,6\~71 months old; phase Ⅱ：6\~71 months old |
| Active control group | ACTIVE_COMPARATOR | phase Ⅰ: 6\~71 months old; phase Ⅱ：6\~71 months old |
| Name | Type | Description |
|---|---|---|
| bivalent enterovirus vaccine (Vero cell), inactivated | BIOLOGICAL | Two doses are administered with a one-month interval between each dose. |
| Enterovirus Type 71 Vaccine (Vero Cell), Inactivated | BIOLOGICAL | Two doses are administered with a one-month interval between each dose. |
| low dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated | BIOLOGICAL | Bivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 480 U-CA16 600 SU/0.5 ml |
| medium dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated | BIOLOGICAL | Bivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 960 U-CA16 600 SU/0.5 ml |
| high dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated | BIOLOGICAL | Bivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 1920U-CA16 1200SU/0.5ml |
| Enterovirus type EV71 vaccine (Vero cell), Inactivated | BIOLOGICAL | Enterovirus type EV71 vaccine (Vero cell), Inactivated (Sinovac) |
Inclusion Criteria: * 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...