Recent Updates
Recently added Catalysts

COVID-19 Vaccine,Inactivated

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment1,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05137418Safety and Immunogenicity of COVID-19 Vaccine, Inactivated in Healthy Population Aged From 3 to 11 YearsPHASE3 COMPLETED 1,000Nov 27, 2021Jan 27, 2023Oct 16, 20231 China
Unlock Drug Trial Details
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
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range3 Years — 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
Unlock Eligibility Criteria