NCT07211152

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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.

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\~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.

Conditions

• Influenza

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-13
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2025-10-07
• Last updated: 2026-01-28

Locations

2 sites across 1 country: Philippines