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SARS-CoV-2 vaccine

Phase 3

SARS-CoV2 Infection | Vaccine | Infectious Disease |Sinovac Biotech, Ltd|Trials Updated: Jan 13, 2022

SARS-CoV-2 vaccine development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Nov 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment1,620

FDA Designations

No designations recorded

SARS-CoV-2 vaccine clinical trials

SARS-CoV-2 vaccine · 1 trial · 1 indication

Phase 3 1
NCT04508075Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated VaccineSARS-CoV2 Infection
COMPLETED1,620 Analytics
PHASE3COMPLETED
Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine
SARS-CoV2 InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of laboratory-confirmed COVID-19 after the second dose
14 days to 6 months after the second dose

Percentage of laboratory-confirmed COVID-19 cases

Secondary Endpoints

Incidence of suspected COVID-19 cases
within 14 days to 6 months after the second dose.
Incidence of laboratory-confirmed cases (severe, critical and death)
within 14 days to 6 months after the second dose
Seroconversion rate anti-S antibody IgG titer (ELISA)
14 days after two doses of vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
SARS-CoV-2 VaccineEXPERIMENTALParticipants receive 2 doses of SARS-CoV-2 Inactivated Vaccine with 14 days interval, intramuscularly
PlaceboPLACEBO_COMPARATORParticipants receive 2 doses of placebo with 14 days interval, intramuscularly

Interventions

NameTypeDescription
SARS-CoV-2 vaccine (inactivated)BIOLOGICALSARS-CoV-2 vaccine (inactivated) manufactured by Sinovac
PlaceboBIOLOGICALPlacebo manufactured by PT. Bio Farma
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Eligibility Criteria

Age Range18 Years to 59 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Clinically healthy adults aged 18 - 59 years. 2. Subjects have been informed properly regarding the study and signed the informed consent form. 3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial. Exclusion Criteria: 1. ...

Countries:Indonesia
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