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EV71 vaccine
The EV71 vaccine stimulates the immune system to produce antibodies and cellular immunity against enterovirus 71, preventing infection and disease.
The EV71 vaccine stimulates the immune system to produce antibodies and cellular immunity against enterovirus 71, preventing infection and disease. Used for Prevention of enterovirus 71 infection and hand, foot, and mouth disease (HFMD) in infants and young children.
At a glance
| Generic name | EV71 vaccine |
|---|---|
| Also known as | EV71 vac |
| Sponsor | Sinovac Biotech Co., Ltd |
| Drug class | inactivated viral vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
EV71 vaccine is an inactivated viral vaccine containing killed enterovirus 71 particles that trigger both humoral (antibody) and cell-mediated immune responses. Upon vaccination, the immune system recognizes viral antigens and develops protective immunity, reducing the risk of EV71 infection and associated hand, foot, and mouth disease (HFMD), particularly severe neurological complications in young children.
Approved indications
- Prevention of enterovirus 71 infection and hand, foot, and mouth disease (HFMD) in infants and young children
Common side effects
- Injection site pain, erythema, or swelling
- Fever
- Irritability or fussiness
Key clinical trials
- Tolerability, Safety, and Immunogenicity of Tetravalent Inactivated Enterovirus Vaccine (Vero Cell). (PHASE1, PHASE2)
- Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial (PHASE1, PHASE2)
- A Study to Evaluate the Immunogenicity and Safety of an EV71 Vaccine (Envacgen®) in Children Aged 6 to <10 Years Compared to Children Aged 2 to <6 Years (PHASE3)
- Study on the Persistence of Immunity Following EV71 Vaccination
- Clinical Trial for Batch Consistency of EV71 Vaccine (PHASE4)
- Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell) (PHASE3)
- A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children (PHASE3)
- Immunogenicity of the Inactivated EV71 Vaccine Combined With Hepatitis B and Group A Meningococcal Vaccine (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- EV71 vaccine CI brief — competitive landscape report
- EV71 vaccine updates RSS · CI watch RSS
- Sinovac Biotech Co., Ltd portfolio CI