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Vaxigrip QIV

Phase 3

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

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Vaxigrip QIV · 1 trial · 1 indication

Phase 3 1
NCT07211152Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Pregnant WomenInfluenza
RECRUITING150 Analytics
PHASE3RECRUITING
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Pregnant Women
Influenza
NCT07211152150
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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 to 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 14 trials

CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK2PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sanofi SA Sponsored ADRSNY2 - Efluelda Tetra Pre-filled syringe
Pfizer Inc.PFE1 - COVID-19 Vaccine
Abbott LaboratoriesABT1N/AUndisclosed
Grace Therapeutics, Inc.GRCE1N/AUndisclosed
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Frequently asked questions about Vaxigrip QIV

What is Vaxigrip QIV used for?

Vaxigrip QIV is an investigational quadrivalent influenza vaccine being studied for the prevention of influenza. It is currently in a Phase 3 clinical trial enrolling pregnant women in the Philippines. The vaccine is designed to protect against four influenza virus strains.

Who makes Vaxigrip QIV?

Vaxigrip QIV is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company traded on the NASDAQ under the ticker symbol SVA. The company is conducting a Phase 3 clinical trial of the vaccine in pregnant women.

What phase is Vaxigrip QIV in?

Vaxigrip QIV is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants and is designed to evaluate the vaccine in pregnant women.

What clinical trials is Vaxigrip QIV in?

Vaxigrip QIV is being studied in a single Phase 3 clinical trial registered as NCT07211152. This randomized, double-blind, active-controlled trial is recruiting 150 pregnant women aged 18 years and older in the Philippines to evaluate the vaccine for influenza prevention.

Is Vaxigrip QIV the same as a quadrivalent influenza vaccine?

Vaxigrip QIV is a quadrivalent influenza vaccine, meaning it is designed to protect against four different influenza virus strains. The 'QIV' in its name stands for quadrivalent influenza vaccine. It is being studied specifically in pregnant women in a Phase 3 trial.