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

NCT07211152 | Recruiting Phase 3

• 1 other identifier: PRO-QINF-3006
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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

Influenza

Keywords

pregnant women

Outcome Measures

Primary Outcomes (5)

• The seroconversion rates (SCRs) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after vaccination.

  SCR 28 days after vaccination.

  28 days after vaccination

• The seroprotection rates (SPRs) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after vaccination.

  SPR 28 days after vaccination.

  28 days after vaccination

• The geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after vaccination.

  GMT 28 days after vaccination.

  28 days after vaccination

• The geometric mean increase (GMI) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after vaccination.

  GMI 28 days after vaccination.

  28 days after vaccination

• Incidence of adverse reactions within 28 days after vaccination

  Incidence of adverse reactions within 28 days after vaccination

  28 days after vaccination

Secondary Outcomes (9)

• The maternal seroconversion rates (SCRs) of HI antibodies against each antigen at the end of gestation period

  at the end of gestation period (date of delivery, estimated to be 4-17 weeks after randomization)

• The maternal seroprotection rates (SPRs) of HI antibodies against each antigen at the end of gestation period

  at the end of gestation period (date of delivery, estimated to be 4-17 weeks after randomization)

• The maternal geometric mean titers (GMTs) of HI antibodies against each antigen at the end of gestation period

  at the end of gestation period (date of delivery, estimated to be 4-17 weeks after randomization)

• The maternal geometric mean increase (GMI) of HI antibodies against each antigen at the end of gestation period

  at the end of gestation period (date of delivery, estimated to be 4-17 weeks after randomization)

• The SPR of HI antibodies against each antigen in the umbilical cord blood at the end of gestation period

  at the end of gestation period (date of delivery, estimated to be 4-17 weeks after randomization)

Study Arms (2)

Test Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Biological: Vaxigrip QIV

Interventions

Vaxigrip QIV BIOLOGICAL

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

Control Group

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

Test Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged 18 to 39 years in good health or medically stable.
• Gestational age of 20 to 32 weeks, based on last menstrual period, early or late ultrasound dating.
• The participant was tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection according to medical records or rapid tests.
• Participants should provide verifiable identification.
• Participants are able to understand and sign the informed consent form voluntarily;
• Participants are willing and able to adhere to visit schedules and all study requirements.

You may not qualify if:

• Receipt of any seasonal influenza vaccine within 6 months prior to enrollment, or plans to receive other influenza vaccines during the study;
• Participants with previous or concurrent dangerous pregnancy complications such as gestational diabetes mellitus (GDM), pregnant induced hypertension, preeclampsia and known uterine anomaly;
• History of preterm delivery, or spontaneous abortion;
• Known fetal congenital anomaly, e.g. genetic abnormality or major congenital malformation based on antenatal ultrasound;
• Signs or symptoms of active preterm labor, defined as regular uterine contractions with cervical change (dilation/effacement);
• History of Guillain-Barré syndrome within 6 weeks of a prior dose of any influenza vaccine;
• Received any vaccine in the 4 weeks prior to study vaccination, or plans to receive any vaccine within 4 weeks after study vaccination;
• Serious allergic reaction or other serious adverse reaction to any influenza vaccines or their components;
• Autoimmune diseases, immunodeficiency, any immunosuppressant within 6 months prior to vaccination (≥ 20mg/day prednisone or equivalent, but corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis are permitted) or cytotoxic therapy, or plans for such treatment during the study;
• Diagnosed abnormal coagulation function (e.g., coagulation factor deficiency, coagulation disorders, or platelet abnormalities), or obvious bruising following venipuncture;
• Significant chronic diseases that, in the judgement of the investigator, might interfere with the study (may include, but are not limited to cardiovascular disease, liver or kidney disorders, HIV infection or malignant tumor);
• Current or history of severe neurological diseases (such as epilepsy, convulsions or seizures) or psychiatric disorders, or family history of psychiatric disorders;
• Acute diseases or acute stage of chronic diseases within 7 days prior to vaccination;
• Receipt of blood, blood-derived products or immunoglobulins within 3 months prior to vaccination or plans for such treatment in the study;
• Alcoholism or history of drug abuse;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (2)

Health Cube Medical Clinics

Mandaluyong, National Capital Region, Philippines

RECRUITING

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

Manila, National Capital Region, Philippines

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Central Study Contacts

April Rose T. Nepomuceno

CONTACT

+63 9328484020; april.nepomuceno@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 7, 2025
• Study Start: October 13, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PH (2)