Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Pregnant Women

Last updated: January 26, 2026
Sponsor: Sinovac Biotech Co., Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Influenza

Treatment

Vaxigrip QIV

Participants will receive one dose of vaccine (0.5 mL) of Sinovac QIV

Clinical Study ID

NCT07211152
PRO-QINF-3006
  • Ages 18-39
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 lateultrasound dating.

  3. The participant was tested negative for HIV, Syphilis, Hepatitis B, Hepatitis Cinfection according to medical records or rapid tests.

  4. Participants should provide verifiable identification.

  5. Participants are able to understand and sign the informed consent form voluntarily;

  6. Participants are willing and able to adhere to visit schedules and all studyrequirements.

Exclusion

Exclusion Criteria:

  1. Receipt of any seasonal influenza vaccine within 6 months prior to enrollment, orplans to receive other influenza vaccines during the study;

  2. Participants with previous or concurrent dangerous pregnancy complications such asgestational diabetes mellitus (GDM), pregnant induced hypertension, preeclampsia andknown uterine anomaly;

  3. History of preterm delivery, or spontaneous abortion;

  4. Known fetal congenital anomaly, e.g. genetic abnormality or major congenitalmalformation based on antenatal ultrasound;

  5. Signs or symptoms of active preterm labor, defined as regular uterine contractionswith cervical change (dilation/effacement);

  6. History of Guillain-Barré syndrome within 6 weeks of a prior dose of any influenzavaccine;

  7. Received any vaccine in the 4 weeks prior to study vaccination, or plans to receiveany vaccine within 4 weeks after study vaccination;

  8. Serious allergic reaction or other serious adverse reaction to any influenzavaccines or their components;

  9. Autoimmune diseases, immunodeficiency, any immunosuppressant within 6 months priorto vaccination (≥ 20mg/day prednisone or equivalent, but corticosteroid spraytherapy for allergic rhinitis and surface corticosteroid therapy for acutenon-concurrent dermatitis are permitted) or cytotoxic therapy, or plans for suchtreatment during the study;

  10. Diagnosed abnormal coagulation function (e.g., coagulation factor deficiency,coagulation disorders, or platelet abnormalities), or obvious bruising followingvenipuncture;

  11. Significant chronic diseases that, in the judgement of the investigator, mightinterfere with the study (may include, but are not limited to cardiovasculardisease, liver or kidney disorders, HIV infection or malignant tumor);

  12. Current or history of severe neurological diseases (such as epilepsy, convulsions orseizures) or psychiatric disorders, or family history of psychiatric disorders;

  13. Acute diseases or acute stage of chronic diseases within 7 days prior tovaccination;

  14. Receipt of blood, blood-derived products or immunoglobulins within 3 months prior tovaccination or plans for such treatment in the study;

  15. Alcoholism or history of drug abuse;

  16. Receipt of other investigational drugs/vaccines within 30 days prior to enrollment,or plan to receive investigational drugs/vaccines during the study period;

  17. Fever on vaccination day, with axillary temperature ≥ 37.3°C pre-vaccination;

  18. Any other factors which are unsuitable for participation in the clinical trial asjudged by the investigator.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Vaxigrip QIV
Phase: 3
Study Start date:
October 13, 2025
Estimated Completion Date:
June 30, 2026

Study Description

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. Written informed consent form (ICF) will be obtained from participants before enrollment. 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.

For immunogenicity assessment, 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 after vaccine administration, 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 by medical record review from enrollment through hospital discharge following delivery.

Connect with a study center

  • Health Cube Medical Clinics

    Mandaluyong 1701966, National Capital Region 7521311
    Philippines

    Active - Recruiting

  • University of the Philippines - Philippine General Hospital (UP-PGH)

    Manila 1701668, National Capital Region 7521311
    Philippines

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.