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

NCT07211152 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-28

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-13
Primary Completion
2026-03-31
Completion
2026-06-30

Countries

  • Philippines

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07211152 on ClinicalTrials.gov