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Inactivated COVID-19 Vaccine

Phase 3

COVID-19 | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Oct 16, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment11,349

FDA Designations

No designations recorded

Clinical trial landscape

Inactivated COVID-19 Vaccine · 1 trial · 1 indication

Phase 3 1
NCT04992260Efficacy, Immunogenicity and Safety of COVID-19 Vaccine , Inactivated in Children and AdolescentsCOVID-19
COMPLETED11,349 Analytics
PHASE3COMPLETED
Efficacy, Immunogenicity and Safety of COVID-19 Vaccine , Inactivated in Children and Adolescents
COVID-19Unlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy index-incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset
14 days after the second dose

Incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset at least 14 days after the second dose

Secondary Endpoints

Efficacy index-incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset
14 days after the first dose
Efficacy index-incidence of RT-PCR confirmed, symptomatic COVID-19 cases with onset in SARS-CoV-2 uninfected participants
14 days after the second dose
Efficacy index-incidence of hospitalization/severe/death caused by COVID-19 with onset
14 days after the second dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Experimental GroupEXPERIMENTALsubjects will receive two doses of inactivated COVID-19 vaccine on day 0 and day 28.
Control GroupPLACEBO_COMPARATORsubjects will receive two doses of placebo on day 0 and day 28.

Interventions

NameTypeDescription
Inactivated COVID-19 VaccineBIOLOGICALThe inactivated COVID-19 vaccine was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection
Controlled vaccineBIOLOGICALThe placebo was manufactured by Sinovac Research\& Development Co., Ltd.The composition is aluminium hydroxide,The appearance of the placebo is consistent with the vaccine, which is a milky-white suspension.
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Eligibility Criteria

Age Range6 Months to 17 Years
SexALL
Healthy VolunteersYes
Study Sites38

Inclusion Criteria: * Healthy children and adolescents aged 6 months to 17 years; * The participants and/or their guardians are able to understand and sign the informed consent voluntarily (in accordance with the local regulations); * Able to comply with study procedures based on the assessment of ...

Countries:ChileMalaysiaPhilippinesSouth Africa
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Frequently asked questions about Inactivated COVID-19 Vaccine

What is Inactivated COVID-19 Vaccine used for?

Inactivated COVID-19 Vaccine is used for the prevention of COVID-19. It is an inactivated vaccine being developed by Sinovac Biotech, Ltd for use in children and adolescents. The vaccine is currently in Phase 3 clinical development and is considered investigational.

Who makes Inactivated COVID-19 Vaccine?

Inactivated COVID-19 Vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company listed on the stock exchange under the ticker SVA. The company is conducting clinical trials to evaluate the vaccine's efficacy, immunogenicity, and safety in pediatric and adolescent populations.

What phase is Inactivated COVID-19 Vaccine in?

Inactivated COVID-19 Vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved for use. A Phase 3 trial has been completed to assess its efficacy, immunogenicity, and safety in children and adolescents.

What clinical trials is Inactivated COVID-19 Vaccine in?

Inactivated COVID-19 Vaccine has one completed Phase 3 clinical trial, identified as NCT04992260. This trial, titled 'Efficacy, Immunogenicity and Safety of COVID-19 Vaccine, Inactivated in Children and Adolescents,' enrolled 11,349 participants and was conducted in Chile, Malaysia, Philippines, and South Africa.

Is Inactivated COVID-19 Vaccine the same as CoronaVac?

Inactivated COVID-19 Vaccine is an inactivated vaccine developed by Sinovac Biotech, Ltd. The company is known for its COVID-19 vaccine CoronaVac, which is also an inactivated vaccine. However, the specific name of the vaccine in this context is not provided, so it is not confirmed whether it is the same as CoronaVac.