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COVID-19 Vaccine, Inactivated

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

CONTROLLED
Total Trials1
Total Enrollment1,000

FDA Designations

No designations recorded

Clinical trial landscape

COVID-19 Vaccine, Inactivated · 1 trial · 1 indication

Phase 3 1
NCT05137418Safety and Immunogenicity of COVID-19 Vaccine, Inactivated in Healthy Population Aged From 3 to 11 YearsCOVID-19
COMPLETED1,000 Analytics
PHASE3COMPLETED
Safety and Immunogenicity of COVID-19 Vaccine, Inactivated in Healthy Population Aged From 3 to 11 Years
COVID-19Unlock trial analytics

Study Endpoints

Primary Endpoints

Immunogenicity index-the GMT of neutralizing antibodies
28 days after the second vaccination

The GMT of neutralizing antibodies 28 days after the second vaccination.

Secondary Endpoints

Immunogenicity index-the seroconversion rate of neutralizing antibodies
28 days after the second vaccination
Immunogenicity index-the seropositive rate of neutralizing antibodies 28 days after the second vaccination
28 days after the second vaccination
Immunogenicity index-GMI of neutralizing antibodies
28 days after the second vaccination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
3-5 years old age groupEXPERIMENTAL500 participants aged 3-5 years will receive two doses of COVID-19 vaccine,inactivated on day 0 and day 28.
6-11 years old age groupEXPERIMENTAL500 participants aged 6-11 years will receive two doses of COVID-19 vaccine,inactivated on day 0 and day 28.

Interventions

NameTypeDescription
COVID-19 Vaccine,InactivatedBIOLOGICALThe COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection
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Eligibility Criteria

Age Range3 Years to 11 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy participants aged 3-11 years; * The participants and/or their guardians are able to understand and sign the informed consent voluntarily (in accordance with the local regulations)(For subjects aged 3-7years ,guardians need to sign the informed consent form,for subjects...

Countries:China
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Frequently asked questions about COVID-19 Vaccine, Inactivated

What is COVID-19 Vaccine, Inactivated used for?

COVID-19 Vaccine, Inactivated is an investigational vaccine being developed for the prevention of COVID-19. It is currently in Phase 3 clinical development and has been studied in healthy populations, including children aged 3 to 11 years, in China.

Who makes COVID-19 Vaccine, Inactivated?

COVID-19 Vaccine, Inactivated is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company. The company's stock is traded under the ticker symbol SVA.

What phase is COVID-19 Vaccine, Inactivated in?

COVID-19 Vaccine, Inactivated 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 evaluate its safety and immunogenicity.

What clinical trials is COVID-19 Vaccine, Inactivated in?

COVID-19 Vaccine, Inactivated has been studied in a completed Phase 3 clinical trial with the identifier NCT05137418. This trial assessed the safety and immunogenicity of the vaccine in healthy individuals aged 3 to 11 years in China, enrolling 1,000 participants.

Is COVID-19 Vaccine, Inactivated a monoclonal antibody?

COVID-19 Vaccine, Inactivated is classified as a monoclonal antibody modality, though it is being developed as a vaccine for COVID-19. It is currently in Phase 3 clinical trials and is not yet approved.