Recent Updates
Recently added Catalysts

Inactivated Enterovirus Type 71 Vaccine

Phase 1

Infection; Viral, Enterovirus | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Mar 15, 2013

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Inactivated Enterovirus Type 71 Vaccine · 1 trial · 1 indication

Phase 1 1
NCT01273233Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy AdultsInfection; Viral, Enterovirus
COMPLETED36 Analytics
PHASE1COMPLETED
Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults
Infection; Viral, EnterovirusUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability of the inactivated Enterovirus Type 71 Vaccine in adults by different doses
3 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1: 200U EV71 vaccineEXPERIMENTAL12 adults received 3 doses of 200U EV71 vaccine 14 days apart
Group 2: 400U EV71 vaccineEXPERIMENTAL12 adults received 3 doses of 400U EV71 vaccine 14 days apart
Group 1: PlaceboPLACEBO_COMPARATOR6 adults received 3 doses of placebo 14 days apart
Group 2: PlaceboPLACEBO_COMPARATOR6 adults received 3 doses of placebo 14 days apart

Interventions

NameTypeDescription
Inactivated Enterovirus Type 71 VaccineBIOLOGICALA Sinovac EV71 vaccine contains inactivated EV71 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and injection water. The EV71 vaccine is supplied in one mono-dose vial containing 0.5 mL of viral suspension with EV71 virus antigen of 200U and 400U (Elisa unit)
PlaceboOTHERPlacebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 49 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy males and females, aged from 18 to 49 years old. Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator 2. Provided legal identification for the sake of recruitment. 3. Subjects are able to under...

Countries:China
Unlock Eligibility Criteria

Frequently asked questions about Inactivated Enterovirus Type 71 Vaccine

What is Inactivated Enterovirus Type 71 Vaccine used for?

Inactivated Enterovirus Type 71 Vaccine is used for the prevention of infection caused by enterovirus type 71, which is a viral infection. It is being developed as a vaccine to protect against this viral pathogen, which can cause hand, foot, and mouth disease and potentially severe neurological complications.

Who makes Inactivated Enterovirus Type 71 Vaccine?

Inactivated Enterovirus Type 71 Vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company. The company's ticker symbol is SVA. Sinovac Biotech is conducting clinical trials to evaluate the safety and efficacy of this vaccine candidate.

What phase is Inactivated Enterovirus Type 71 Vaccine in?

Inactivated Enterovirus Type 71 Vaccine is currently in Phase 1 clinical development. It is an investigational vaccine that has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine is still in the early stages of clinical testing.

What clinical trials is Inactivated Enterovirus Type 71 Vaccine in?

Inactivated Enterovirus Type 71 Vaccine has one completed clinical trial with the identifier NCT01273233. The trial was titled 'Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults' and was a Phase 1, randomized, double-blind, placebo-controlled study conducted in China with 36 healthy adult participants.

Is Inactivated Enterovirus Type 71 Vaccine the same as other enterovirus vaccines?

Inactivated Enterovirus Type 71 Vaccine is a specific vaccine candidate developed by Sinovac Biotech. It is an inactivated vaccine, meaning it contains killed virus particles. There are other enterovirus vaccines in development, but this particular vaccine is distinct and is being evaluated in its own clinical trial program.