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Adsorbed COVID-19 Vaccine

Phase 3

COVID-19 | Vaccine | Infectious Disease |Sinovac Biotech, Ltd|Trials Updated: Feb 15, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment12,688

FDA Designations

No designations recorded

Adsorbed COVID-19 Vaccine clinical trials

Adsorbed COVID-19 Vaccine · 1 trial · 1 indication

Phase 3 1
NCT04456595Clinical Trial of Efficacy and Safety of Sinovac's Adsorbed COVID-19 (Inactivated) Vaccine in Healthcare ProfessionalsCOVID-19
COMPLETED12,688 Analytics
PHASE3COMPLETED
Clinical Trial of Efficacy and Safety of Sinovac's Adsorbed COVID-19 (Inactivated) Vaccine in Healthcare Professionals
COVID-19
NCT0445659512,688
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Study Endpoints

Primary Endpoints

Incidence of COVID-19 cases after two-doses immunization schedule
Two weeks after second dose up to one year after first dose

Number of virologically-confirmed symptomatic COVID-19 two weeks after second dose of vaccine

Frequency of adverse events up to seven days after immunization
Seven days after each immunization

Frequency of adverse reaction in the seven days following each immunization per age group

Secondary Endpoints

Incidence of COVID-19 cases after two-doses immunization schedule according to previous exposure
Two weeks after first dose up to one year after first dose
Incidence of COVID-19 cases after 14-days of first immunization
Two weeks after last dose uup to one year after first dose
Combined incidence of SARS-CoV-2 infection
Two weeks after second dose up to one year after first dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Adult - VaccineEXPERIMENTALParticipants aging 18-59 years receiving two doses with 14-days interval of Adsorbed COVID-19 (inactivated) Vaccine
Elderly - VaccineEXPERIMENTALParticipants aging 60 years or above receiving two doses with 14-days interval of Adsorbed COVID-19 (inactivated) Vaccine
Adult - PlaceboPLACEBO_COMPARATORParticipants aging 18-59 years receiving two doses with 14-days interval of placebo
Elderly - PlaceboPLACEBO_COMPARATORParticipants aging 60 years or above receiving two doses with 14-days interval of placebo

Interventions

NameTypeDescription
Adsorbed COVID-19 (inactivated) VaccineBIOLOGICALAdsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
PlaceboBIOLOGICALPlacebo of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites16

Inclusion Criteria: 1. Adults 18 years of age or older; 2. Healthcare professionals who work in direct contact care of people with possible or confirmed COVID-19 cases; 3. Agree with periodic contacts by phone or electronic means, and home visits; 4. Show voluntary intention to participate in the s...

Countries:Brazil
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Competitive Landscape -COVID-19 55 trials

Top 10 of 12 competitors

CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE7PHASE3ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV
BioNTech SE Sponsored ADRBNTX1PHASE3BNT162b2
Merck & Co., Inc.MRK2PHASE3Molnupiravir
Invivyd, Inc.IVVD3PHASE3VYD2311
Vanda Pharmaceuticals Inc.VNDA1PHASE3Tradipitant
Moderna, Inc.MRNA2PHASE2mRNA-1283, mRNA-1273
ImmunityBio IncIBRX2PHASE2Nogapendekin alfa inbakicept
Traws Pharma, Inc.TRAW1PHASE2Ratutrelvir
GeoVax Labs, Inc.GOVX1PHASE2GEO-CM04S1
Gilead Sciences, Inc.GILD1PHASE2Remdesivir
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