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SARS-CoV-2 inactivated vaccine

Phase 3

Covid19 | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Feb 2, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment2,300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04651790Efficacy, Safety, and Immunogenicity of Two Vaccination Schedules of an Inactivated Vaccine Against COVID-19 in AdultsPHASE3 COMPLETED 2,300 — — Nov 27, 2020Nov 1, 2022Feb 2, 20231 Chile
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Study Endpoints
Primary Endpoints
Frequency of solicited and unsolicited adverse events that occur during the period of one week after each dose of the vaccine in two vaccination schedules: 0,14 and 0,28 days stratified by age group (18-59 years, and 60 or more years).
During the first 7 days after each dose of vaccine

The frequency of solicited and unsolicited local and systemic adverse reactions will be registered. This will be measured during the first 7 days after each vaccination. These adverse reactions will be registered according to the age group in adults (18-59 years old) and the elderly (60 years of age or older).

Incidence of symptomatic cases of virologically confirmed COVID-19 two weeks after the second dose of each vaccination schedule.
Two weeks after second dose up to one year after first dose

Vaccine efficacy to prevent virologically confirmed COVID-19 two weeks after the second dose of each vaccination schedule will be determined

Secondary Endpoints
Incidence of hospitalized cases of COVID-19 two weeks after the second vaccination of two vaccination schedules
Since two weeks after the second dose of two vaccination schedules and up 12 month after first dose
Incidence of severe cases or deaths of COVID-19 virologically confirmed two weeks after the second vaccination of two vaccination schedules
Since two weeks after the second dose up 12 month after first dose
Incidence of adverse reactions to the vaccine, local and systemic, solicited and unsolicited, within the period of four weeks after each vaccination of two vaccination schedules, according to the age, adults (18-59 years old) and elder (>60 years)
Four weeks after each dose of vaccine in two vaccination schedules
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Vaccine 0-14ACTIVE_COMPARATORInactivated vaccine against SARS-CoV-2 2 doses on day 0 and 14
Vaccine 0-28EXPERIMENTALInactivated vaccine against SARS-CoV-2 2 doses on day 0 and 28
Interventions
NameTypeDescription
SARS-CoV-2 inactivated vaccineBIOLOGICALThe vaccine contains inactivated SARS-CoV-2 virus, aluminum hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate and sodium chloride.The final product will be supplied in a pre-filled syringe containing 0.5 ml of solution for injection that corresponds to a dose of the vaccine.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Adults over 18 years of age. * Demonstrate the capacity to understand and sign the Informed Consent document. * Agree to comply with the study procedures and visits. Exclusion Criteria: * History of confirmed symptomatic SARS CoV-2 infection. * Pregnant (confirmed by positiv...

Countries:Chile
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