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Cell-based Trivalent Split Influenza Virus Vaccine

Phase 1

Seasonal Influenza | Vaccine | Infectious Disease |Sinovac Biotech, Ltd|Trials Updated: Oct 22, 2026

Cell-based Trivalent Split Influenza Virus Vaccine target and mechanism

ModalityVaccine

Also known as Cell-based Trivalent Split Influenza Virus Vaccine (cTIV)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment175

FDA Designations

No designations recorded

Cell-based Trivalent Split Influenza Virus Vaccine clinical trials

Cell-based Trivalent Split Influenza Virus Vaccine · 1 trial · 1 indication

Phase 1 1
NCT07889193Phase I Clinical Trial of Trivalent Inactivated Split Influenza Virus Vaccine (MDCK Cell)Seasonal Influenza
NOT YET_RECRUITING175 Analytics
PHASE1NOT YET_RECRUITING
Phase I Clinical Trial of Trivalent Inactivated Split Influenza Virus Vaccine (MDCK Cell)
Seasonal InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse reactions
0-28 days after each dose

Incidence of adverse reactions from Day 0 to Day 28 after each dose

Secondary Endpoints

Incidence of adverse reactions
0-7 days after each dose
Incidence of serious adverse events(SAEs)
From the first dose up to 6 months after the last dose
Incidence of abnormal and clinically significant hematology, serum biochemistry and urinalysis parameters on Day 3 after vaccination
Day 3 after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Investigational Group :Cell-based Trivalent Split Influenza Virus Vaccine (cTIV)EXPERIMENTALChildren aged 6-35 months and vaccine-naïve children aged 3-8 years: 2 doses administered 28 days apart. All other participants: 1 single dose
Active Comparator Group: Egg-based Trivalent Split Influenza Virus Vaccine (eTIV)ACTIVE_COMPARATORChildren aged 6-35 months and vaccine-naïve children aged 3-8 years: 2 doses administered 28 days apart. All other participants: 1 single dose
Placebo Group: PlaceboPLACEBO_COMPARATORChildren aged 6-35 months and vaccine-naïve children aged 3-8 years: 2 doses administered 28 days apart. All other participants: 1 single dose

Interventions

NameTypeDescription
Cell-based Trivalent Split Influenza Virus Vaccine (cTIV)BIOLOGICALInvestigational trivalent split influenza virus vaccine produced in MDCK cells, administered intramuscularly.
Egg-based Trivalent Split Influenza Virus Vaccine (eTIV)BIOLOGICALLicensed trivalent split influenza virus vaccine (Anflu) produced in embryonated chicken eggs, administered intramuscularly.
PlaceboOTHER0.9% normal saline for intramuscular injection.
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Eligibility Criteria

Age Range6 Months to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy trial participants aged ≥6 months; Among them, for children aged 3-8 years: * Influenza vaccine-naïve: children who have never received any influenza vaccine (licensed or investigational); * Previously vaccinated: children who have received at least 1 dose o...

Countries:China
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Recent Changes (Last 90 Days)

LOWOct 22, 2026NCT07889193NEW_TRIAL: changed
LOWOct 22, 2026NCT07889193NEW_TRIAL: changed