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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...
It is an investigational vaccine developed by Sinovac Biotech, Ltd (SVA) for the prevention of Hand, Foot, and Mouth Disease (HFMD). It is a tetravalent, inactivated vaccine produced using Vero cell technology, designed to be given at a low dose. It is currently in Phase 3 clinical development.
It is being developed for the prevention of Hand, Foot, and Mouth Disease (HFMD) and herpangina. Both clinical trials of the vaccine list HFMD and herpangina as the conditions under study. The vaccine is intended for healthy volunteers, including children from 6 months of age.
Sinovac Biotech, Ltd, which trades under the ticker SVA, is the developer of the low-dose tetravalent inactivated enterovirus vaccine (Vero cell). The company is running the clinical program for the vaccine in China, where both of its trials are being conducted.
The vaccine is in Phase 3 clinical development. A Phase 3 trial, NCT07611513, is planned with an enrollment of 6,000 participants and is currently not yet recruiting. An earlier Phase 1 trial, NCT06754384, has been completed. The vaccine is investigational and has not been approved.
Two trials have been registered. NCT07611513 is a Phase 3 trial of protective efficacy, immunogenicity, and safety with 6,000 planned participants, listed as not yet recruiting. NCT06754384 is a completed Phase 1 trial of tolerability, safety, and immunogenicity that enrolled 552 participants. Both are randomized, double-blind, and placebo-controlled.
Yes. The low-dose tetravalent inactivated enterovirus vaccine is also known as the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell), or simply the Tetravalent Inactivated Enterovirus Vaccine. These names refer to the same Sinovac Biotech (SVA) candidate for Hand, Foot, and Mouth Disease.