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

Sponsor
Sinovac Biotech Co., Ltd
Study ID
NCT07211152
Phase
PHASE3
Status
Recruiting
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Conditions

  • Influenza

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 39 Years
Healthy Volunteers
Accepted

Interventions

  • Participants will receive one dose of vaccine (0.5 mL) of Sinovac QIV — BIOLOGICAL
    Participants will receive one dose of vaccine (0.5 mL) of Sinovac QIV
  • Vaxigrip QIV — BIOLOGICAL
    Participants will receive one dose of vaccine (0.5 mL) of Vaxigrip QIV

Study Details

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.

Key Dates

First listed
Oct 7, 2025
Start date
Oct 13, 2025
Status verified
Jan 2026
Primary completion
Mar 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Test Group
    Participants will receive one dose of vaccine (0.5 mL) of Sinovac QIV
  • Active Comparator: Control Group
    Participants will receive one dose of vaccine (0.5 mL) of Vaxigrip QIV

Primary Outcome Measure

The seroconversion rates (SCRs) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after vaccination. [ Time Frame: 28 days after vaccination ]

Central Contacts

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