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RECRUITING
NCT07211152
PHASE3

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

Sponsor: Sinovac Biotech Co., Ltd

View on ClinicalTrials.gov

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.

Official title: A Phase Ⅲ, Randomized, Double-blind, Positive Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of an Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Pregnant Women

Key Details

Gender

FEMALE

Age Range

18 Years - 39 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-10-13

Completion Date

2026-06

Last Updated

2026-01-28

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

Vaxigrip QIV

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

Locations (2)

Health Cube Medical Clinics

Mandaluyong, National Capital Region, Philippines

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

Manila, National Capital Region, Philippines