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NOT YET RECRUITING
NCT07832201
PHASE4

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

Sponsor: Sinovac Biotech Co., Ltd

View on ClinicalTrials.gov

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.

Official title: A Phase IV, Randomized, Double-blind, Positive-controlled , Multicenter Clinical Trial to Evaluate the Immunogenicity and Safety of Influenza Vaccine (Split Virion) , Inactivated (Anflu®) in Pregnant Women

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-10

Completion Date

2027-04

Last Updated

2026-09-21

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Anflu®

Participants will receive one dose of Sinovac Anflu® .

BIOLOGICAL

Vaxigrip®

Participants will receive one dose of Sanofi Vaxigrip®.

Locations (6)

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