Status:
NOT_YET_RECRUITING
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Pregnant Women
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Influenza
Eligibility:
FEMALE
18-39 years
Phase:
PHASE3
Brief 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\~...
Detailed 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\~...
Eligibility Criteria
Inclusion
- 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, early or late ultrasound dating.
- The participant was tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection according to medical records or rapid tests.
- Participants should provide verifiable identification.
- Participants are able to understand and sign the informed consent form voluntarily;
- Participants are willing and able to adhere to visit schedules and all study requirements.
Exclusion
- Receipt of any seasonal influenza vaccine within 6 months prior to enrollment, or plans to receive other influenza vaccines during the study;
- Participants with previous or concurrent dangerous pregnancy complications such as gestational diabetes mellitus (GDM), pregnant induced hypertension, preeclampsia and known uterine anomaly;
- History of preterm delivery, or spontaneous abortion;
- Known fetal congenital anomaly, e.g. genetic abnormality or major congenital malformation based on antenatal ultrasound;
- Signs or symptoms of active preterm labor, defined as regular uterine contractions with cervical change (dilation/effacement);
- History of Guillain-Barré syndrome within 6 weeks of a prior dose of any influenza vaccine;
- Received any vaccine in the 4 weeks prior to study vaccination, or plans to receive any vaccine within 4 weeks after study vaccination;
- Serious allergic reaction or other serious adverse reaction to any influenza vaccines or their components;
- Autoimmune diseases, immunodeficiency, any immunosuppressant within 6 months prior to vaccination (≥ 20mg/day prednisone or equivalent, but corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis are permitted) or cytotoxic therapy, or plans for such treatment during the study;
- Diagnosed abnormal coagulation function (e.g., coagulation factor deficiency, coagulation disorders, or platelet abnormalities), or obvious bruising following venipuncture;
- Significant chronic diseases that, in the judgement of the investigator, might interfere with the study (may include, but are not limited to cardiovascular disease, liver or kidney disorders, HIV infection or malignant tumor);
- Current or history of severe neurological diseases (such as epilepsy, convulsions or seizures) or psychiatric disorders, or family history of psychiatric disorders;
- Acute diseases or acute stage of chronic diseases within 7 days prior to vaccination;
- Receipt of blood, blood-derived products or immunoglobulins within 3 months prior to vaccination or plans for such treatment in the study;
- Alcoholism or history of drug abuse;
- Receipt of other investigational drugs/vaccines within 30 days prior to enrollment, or plan to receive investigational drugs/vaccines during the study period;
- Fever on vaccination day, with axillary temperature ≥ 37.3°C pre-vaccination;
- Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07211152
Start Date
November 1 2025
End Date
June 1 2026
Last Update
October 7 2025
Active Locations (2)
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1
Health Cube Medical Clinics
Mandaluyong, National Capital Region, Philippines
2
University of the Philippines - Philippine General Hospital (UP-PGH)
Manila, National Capital Region, Philippines