Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tetravalent Inactivated Enterovirus Vaccine (Vero Cell), Tetravalent Inactivated Enterovirus Vaccine
Low-dose of tetravalent inactivated enterovirus vaccine · 2 trials · 3 indications
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.
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.
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.
Incidence rate of AR from vaccination onset to 30 days post-full immunization in children aged 6 months to 12 years.
The seropositive conversion rates of neutralizing antibodies against EV71, CA16, CA10, and CA6 on the 30th day after full vaccination in children aged 6 months to 12 years.
The GMT of neutralizing antibodies against EV71, CA16, CA10, and CA6 on the 30th day after full vaccination in children aged 6 months to 12 years.
| Arm | Type | Description |
|---|---|---|
| Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) | EXPERIMENTAL | 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. |
| placebo | PLACEBO_COMPARATOR | 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. |
| Low-dose of tetravalent inactivated enterovirus vaccine (Vero cell) | EXPERIMENTAL | Low-dose of tetravalent inactivated enterovirus vaccine (Vero cell)(Only for phase Ⅰ) |
| Medium-dose of tetravalent inactivated enterovirus vaccine (Vero cell) | EXPERIMENTAL | Medium-dose of tetravalent inactivated enterovirus vaccine (Vero cell) |
| High-dose of tetravalent inactivated enterovirus vaccine (Vero cell) | EXPERIMENTAL | High-dose of tetravalent inactivated enterovirus vaccine (Vero cell) |
| EV71 vaccine | ACTIVE_COMPARATOR | EV71 vaccine (for ages 6-71 months) |
| Name | Type | Description |
|---|---|---|
| Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) | BIOLOGICAL | Two doses are administered with a one-month interval between each dose. |
| Placebo | BIOLOGICAL | Two doses are administered with a one-month interval between each dose. |
| Low-dose of tetravalent inactivated enterovirus vaccine (Vero cell) | BIOLOGICAL | Low-dose tetravalent inactivated enterovirus vaccine (Vero cell) )(only for phase Ⅰ） |
| Medium-dose tetravalent inactivated enterovirus vaccine (Vero cell) | BIOLOGICAL | Medium-dose tetravalent inactivated enterovirus vaccine (Vero cell) |
| High-dose tetravalent inactivated enterovirus vaccine (Vero cell) ) | BIOLOGICAL | High-dose tetravalent inactivated enterovirus vaccine (Vero cell) ) |
| EV71 inactivated enterovirus vaccine (Vero cell) )(for ages 6-71 months） | BIOLOGICAL | EV71 inactivated enterovirus vaccine (Vero cell) )(for ages 6-71 months） |
| placebo (for ages 6-12 years) | BIOLOGICAL | placebo (for ages 6-12 years) |
Inclusion Criteria: 1. Healthy children aged 6 to 71 months. 2. Guardians who can understand and voluntarily sign the informed consent form 3. Willing and able to comply with all visit schedules, sample collection, vaccinations, and other trial procedures。 4. Provide legal identification for the pa...