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Clinical Trials in China / NCT07832201
Starting soon Phase 4

A Phase IV Clinical Trial of Influenza Vaccine (Split Virion), Inactivatedin (Anflu®) Pregnant Women (AnFLU-PREG)

NCT07832201 · tracked via the Priya Life Science China tracker
Sponsor
Sinovac Biotech Co., Ltd
Phase
Phase 4
Started
2026-10
Last updated
2026-09-21

Condition(s) studied

Influenza

Investigational drug(s) / intervention(s)

Anflu®Vaxigrip®

Anflu®: Participants will receive one dose of Sinovac Anflu® .

Vaxigrip®: Participants will receive one dose of Sanofi Vaxigrip®.

Study summary

A phase IV clinical trial of Influenza Vaccine (Split Virion), Inactivated (Anflu®) developed by Sinovac Biotech Co., Ltd will be conducted in pregnant women.

A total of 150 healthy pregnant women aged 18\~45 years at 22 to 34 weeks (+6 days) 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 Influenza Vaccine (Split Virion) , Inactivated (Anflu®) or Sanofi VAXIGRIP®, respectively.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Healthy pregnant women aged 18 to 45 years (inclusive) with stable health status, at 22 to 34 weeks (+6 days) of gestation. Gestational age is determined based on early ultrasound examination, or based on the last menstrual period if early ultrasound is unavailable. 2. Participants are able to understand and sign the informed consent form voluntarily; 3. Participants are willing and able to adhere to visit schedules and maintain accessible contact throughout the study period; 4. Participants should provide verifiable identification; 5. Have a singleton pregnancy; 6. Have normal non-invasive prenatal DNA test and systematic ultrasound results during the current pregnancy; normal amniocentesis results are required if the test has been performed. Exclusion Criteria: 1. Have a history of two or more preterm deliveries (delivery before 37 weeks of gestation), previous infants with low birth weight (birth weight \<2500 g), or a history of neonatal asphyxia or neonatal neurological damage; 2. Have a history of multiple unexplained spontaneous abortions; 3. Have received any influenza vaccine or the influenza vaccine for the current influenza season within 6 months prior to enrollment, or plan to receive influenza vaccination during the study period. 4. Have suffered from seasonal influenza within 6 months prior to enrollment. 5. Have a history of Guillain-Barré syndrome within 6 weeks after previous influenza vaccination. 6. Have allergic reactions or other severe adverse reactions to any influenza vaccine or its components. 7. Have severe autoimmune diseases or immunodeficiency diseases (including but not limited to active systemic lupus erythematosus, rheumatoid arthritis, asplenia, functional asplenia, and HIV infection) and are judged unsuitable for vaccination by the investigator. 8. Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders or platelet abnormalities). 9. Have severe chronic diseases (including but not limited to cardiovascular diseases, partial liver diseases, renal diseases or malignant tumors) that may interfere with the study as judged by the investigator. 10. Have a current or previous history of severe neurological diseases (epilepsy, convulsions) or psychiatric disorders, or have a family history of psychiatric disorders. 11. Received corticosteroids (adult prednisone ≥20 mg/day or equivalent) or other immunosuppressants for ≥14 days, or cytotoxic therapy within 6 months prior to vaccination, or plan to receive such therapy during the study period. 12. Received immunoglobulins or other blood products within 3 months prior to vaccination, or plan to receive such products during the study period. 13. Received any vaccine within 28 days prior to study vaccination, or plan to receive any vaccine within 28 days after study vaccination. 14. Have enrolled in other clinical trials of investigational drugs or vaccines during the follow-up period, or plan to receive investigational drugs or vaccines during the study period. 15. Have acute diseases or acute exacerbation of chronic diseases within 7 days before vaccination. 16. Have fever on the scheduled vaccination day with an axillary temperature ≥37.3 °C before vaccination. 17. Have clinically significant abnormal laboratory findings as judged by the investigator, or meet any of the following laboratory criteria: a) White blood cell count \>15.0×10\^9/L; b) Neutrophil percentage \>85%; c) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 times the upper limit of normal (2×ULN); d) Total bilirubin \>2 times the upper limit of normal (2×ULN). 18. Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Hunan Provincial Maternal and Child Health Care Hospital Changsha China
Chengdu Women's and Children's Central Hospital Chengdu China
The First Affiliated Hospital of Chongqing Medical University Chongqing China
Nanfang Hospital, Southern Medical University Guangzhou China
Nanjing Drum Tower Hospita Nanjing China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan China

More Sinovac Biotech Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07832201 on ClinicalTrials.gov ↗ ← All trials in China