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Inactivated SARS-CoV-2 Vaccine

Phase 3

COVID-19 | Monoclonal antibody | Infectious Disease |Healthcare Services Group|Last Updated: Jun 18, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment44,101
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04510207A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and AbovePHASE3 COMPLETED 44,101Jul 16, 2020Dec 31, 2021Jun 18, 20236 Bahrain, Egypt +2
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Study Endpoints
Primary Endpoints
The incidence of COVID-19 cases after two-doses of vaccination
From14 days after the second dose to 6 month after the second dose
The incidence of COVID-19 cases after the booster dose of immunization
From 14 days after the booster dose
Secondary Endpoints
The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination
From 14 day after the second dose to 6 month after the second dose
The incidence of any adverse reactions/events
28 days after each immunization
The incidence of serious adverse events (SAE)
From the beginning of the first dose to 12 months after the second immunization
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Investigational Vaccine 1EXPERIMENTALParticipants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP according to the immunization schedule of D0 \& D21.
Investigational Vaccine 2EXPERIMENTALParticipants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP according to the immunization schedule of D0 \& D21.
PlaceboPLACEBO_COMPARATORParticipants will receive 2 doses of Placebo according to the immunization schedule of D0 \& D21.
Investigational Vaccine 1bEXPERIMENTALParticipants will receive a booster dose of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP after 3 months following two doses of immunization.
Investigational Vaccine 2bEXPERIMENTALParticipants will receive a booster dose of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP after 3 months following two doses of immunization.
Placebo-bPLACEBO_COMPARATORParticipants will receive a booster dose of Placebo after 3 months following two doses of immunization.
Interventions
NameTypeDescription
Inactivated SARS-CoV-2 Vaccine (Vero cell)BIOLOGICALThe inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
PlaceboBIOLOGICALThe placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: 1. Healthy subjects aged 18 years old and above. 2. By asking for medical history and physical examination, the investigator judged that the health condition is well. 3. Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine preg...

Countries:BahrainEgyptJordanUnited Arab Emirates
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