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SARS-CoV-2 Inactivated Vaccine

Phase 2

COVID-19 | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Sep 22, 2023

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment500

FDA Designations

No designations recorded

Clinical trial landscape

SARS-CoV-2 Inactivated Vaccine · 1 trial · 1 indication

Phase 2 1
NCT04884685Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Children and AdolescentsCOVID-19
COMPLETED500 Analytics
PHASE2COMPLETED
Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Children and Adolescents
COVID-19Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety index-incidence of adverse reactions
Day 0-28 after each dose

Incidence rate of adverse reactions occured from the beginning of the vaccination to 28 days after the second dose.

Secondary Endpoints

Safety index-incidence of adverse reactions
Day 0-7 after each dose vaccination
Safety index-incidence of serious adverse events
From the beginning of the vaccination to 6 months after the second dose vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Experimental GroupEXPERIMENTALParticipant will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine . Vaccine will given by intramuscular injection on day 0 and day 28.
Control GroupPLACEBO_COMPARATORPlacebo will receive two doses of placebo. The placebo will given by intramuscular injection on day 0 and day 28.

Interventions

NameTypeDescription
SARS-CoV-2 Inactivated VaccineBIOLOGICAL600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
PlaceboBIOLOGICALaluminium hydroxide solution only
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Eligibility Criteria

Age Range3 Years to 17 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy children and adolescents aged 3-17 years; * The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form); * Proven legal identity. Exclusi...

Countries:China
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Frequently asked questions about SARS-CoV-2 Inactivated Vaccine

What is SARS-CoV-2 Inactivated Vaccine used for in COVID-19?

SARS-CoV-2 Inactivated Vaccine is an investigational vaccine being studied for the prevention of COVID-19. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The vaccine is designed to elicit an immune response against the SARS-CoV-2 virus, which causes COVID-19.

Who makes SARS-CoV-2 Inactivated Vaccine?

SARS-CoV-2 Inactivated Vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company traded on the stock exchange under the ticker symbol SVA. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in the target population.

What phase is SARS-CoV-2 Inactivated Vaccine in?

SARS-CoV-2 Inactivated Vaccine is currently in Phase 2 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The ongoing clinical program aims to assess the vaccine's safety and immune response in children and adolescents aged 3 years and older.

What clinical trials is SARS-CoV-2 Inactivated Vaccine in?

SARS-CoV-2 Inactivated Vaccine has one completed clinical trial registered under NCT04884685, titled 'Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Children and Adolescents'. This Phase 2, randomized, double-blind, placebo-controlled trial enrolled 500 participants in China to evaluate the vaccine's safety.

Is SARS-CoV-2 Inactivated Vaccine the same as CoronaVac?

Yes, SARS-CoV-2 Inactivated Vaccine is also known as CoronaVac. The clinical trial NCT04884685 refers to the vaccine as CoronaVac, indicating that these names refer to the same investigational vaccine being developed by Sinovac Biotech for the prevention of COVID-19.