Actively Recruiting
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Pregnant Women
Led by Sinovac Biotech Co., Ltd · Updated on 2026-01-28
150
Participants Needed
2
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blind, positive controlled phase Ⅲ clinical trial to assess the immunogenicity and safety of Sinovac QIV in pregnant women. A total of 150 healthy pregnant women aged 18\~39 years at 20 to 32 weeks of pregnancy will be enrolled. All participants will be randomized to test group and control group in a ratio of 2:1 and receive one dose of vaccine (0.5 mL) of Sinovac QIV or Vaxigrip QIV, respectively. Blood samples will be collected from participants prior to vaccination and 28 days after vaccination. Moreover, to evaluate trans-placental antibodies, blood samples at the end of the gestation period (delivery) and the cord blood sample will be collected, if applicable. For safety assessment, any immediate adverse events within 30 minutes, solicited local and systemic adverse events within 7 days and unsolicited adverse events within 28 days will be collected. Serious adverse events will be collected within 8 weeks after delivery. Pregnancy and birth outcomes will be collected as well.
CONDITIONS
Official Title
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Pregnant Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women aged 18 to 39 years in good health or medically stable
- Gestational age of 20 to 32 weeks, based on last menstrual period or ultrasound
- Tested negative for HIV, Syphilis, Hepatitis B, and Hepatitis C infections
- Provide verifiable identification
- Able to understand and voluntarily sign informed consent
- Willing and able to follow visit schedules and study requirements
You will not qualify if you...
- Receipt of any seasonal influenza vaccine within 6 months before enrollment or plans to receive another influenza vaccine during the study
- Previous or current serious pregnancy complications like gestational diabetes, pregnancy-induced hypertension, preeclampsia, or uterine anomaly
- History of preterm delivery or spontaneous abortion
- Known fetal congenital anomalies detected by ultrasound
- Signs or symptoms of active preterm labor
- History of Guillain-Barré syndrome within 6 weeks after any influenza vaccine dose
- Receipt of any vaccine within 4 weeks before or planned within 4 weeks after study vaccination
- Serious allergic reactions to influenza vaccines or their components
- Autoimmune diseases, immunodeficiency, recent immunosuppressant or cytotoxic therapy
- Abnormal blood clotting or significant bruising after blood draws
- Significant chronic diseases that might interfere with the study
- Current or past severe neurological or psychiatric disorders or family history of psychiatric disorders
- Acute illness or flare of chronic disease within 7 days before vaccination
- Receipt of blood products or immunoglobulins within 3 months before vaccination or plans for such treatment
- Alcoholism or history of drug abuse
- Receipt of investigational drugs or vaccines within 30 days before enrollment or plans during the study
- Fever (axillary temperature ≥ 37.3°C) on vaccination day
- Any other conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Health Cube Medical Clinics
Mandaluyong, National Capital Region, Philippines
Actively Recruiting
2
University of the Philippines - Philippine General Hospital (UP-PGH)
Manila, National Capital Region, Philippines
Actively Recruiting
Research Team
A
April Rose T. Nepomuceno
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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