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Vaxigrip QIV

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Jan 28, 2026

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07211152Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Pregnant WomenPHASE3 RECRUITING 150 — — Oct 13, 2025Jun 1, 2026Jan 28, 20262 Philippines
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Study Endpoints
Primary Endpoints
The seroconversion rates (SCRs) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after vaccination.
28 days after vaccination

SCR 28 days after vaccination.

The seroprotection rates (SPRs) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after vaccination.
28 days after vaccination

SPR 28 days after vaccination.

The geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after vaccination.
28 days after vaccination

GMT 28 days after vaccination.

The geometric mean increase (GMI) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after vaccination.
28 days after vaccination

GMI 28 days after vaccination.

Incidence of adverse reactions within 28 days after vaccination
28 days after vaccination
Secondary Endpoints
The maternal seroconversion rates (SCRs) of HI antibodies against each antigen at the end of gestation period
at the end of gestation period (date of delivery, estimated to be 4-17 weeks after randomization)
The maternal seroprotection rates (SPRs) of HI antibodies against each antigen at the end of gestation period
at the end of gestation period (date of delivery, estimated to be 4-17 weeks after randomization)
The maternal geometric mean titers (GMTs) of HI antibodies against each antigen at the end of gestation period
at the end of gestation period (date of delivery, estimated to be 4-17 weeks after randomization)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Test GroupEXPERIMENTALParticipants will receive one dose of vaccine (0.5 mL) of Sinovac QIV
Control GroupACTIVE_COMPARATORParticipants will receive one dose of vaccine (0.5 mL) of Vaxigrip QIV
Interventions
NameTypeDescription
Participants will receive one dose of vaccine (0.5 mL) of Sinovac QIVBIOLOGICALParticipants will receive one dose of vaccine (0.5 mL) of Sinovac QIV
Vaxigrip QIVBIOLOGICALParticipants will receive one dose of vaccine (0.5 mL) of Vaxigrip QIV
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Eligibility Criteria
Age Range18 Years — 39 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Pregnant women aged 18 to 39 years in good health or medically stable. 2. Gestational age of 20 to 32 weeks, based on last menstrual period, early or late ultrasound dating. 3. The participant was tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection according...

Countries:Philippines
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Competitive Landscape -Influenza 16 trials
CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK3PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3, Zanamivir
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Traws Pharma, Inc.TRAW2PHASE2TRX-100, Influenza A/France/759/2021 virus
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Sanofi SA Sponsored ADRSNY3PHASE1Trivalent messenger ribonucleic acid hemagglutinin Vaccine 1, TIV mRNA-neuraminidase, TIV mRNA-HA Vaccine 2, Quadrivalent Influenza Standard Dose Vaccine, Efluelda Tetra Pre-filled syringe
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Unity Health TorontoUBX1PHASE3Baloxavir
Pfizer Inc.PFE1 — COVID-19 Vaccine
Abbott LaboratoriesABT1NAUndisclosed
Grace Therapeutics, Inc.GRCE1NAUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07211152primaryCompletionDate: changed
LOWMay 24, 2026NCT07211152studyFirstPostDate: changed