Quadrivalent inactivated influenza vaccine for 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

This trial will test whether the Sinovac quadrivalent inactivated flu vaccine produces protective antibodies and is safe for pregnant women between 20 and 32 weeks of gestation compared with Vaxigrip.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 39 Years
• Sex: Female
• Sponsor: Sinovac Biotech Co., Ltd (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 2 sites (Mandaluyong, National Capital Region and 1 other locations)
• Trial ID: NCT07211152 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, positive-controlled Phase 3 trial will enroll 150 healthy pregnant women aged 18-39 at 20-32 weeks' gestation, randomized 2:1 to receive a single 0.5 mL dose of Sinovac QIV or Vaxigrip QIV. Blood samples are collected before vaccination and 28 days after vaccination to measure immunogenicity, with additional maternal and cord blood samples at delivery to assess trans-placental antibody transfer. Safety monitoring includes immediate events for 30 minutes, solicited local and systemic events for 7 days, unsolicited events for 28 days, and serious adverse events up to 8 weeks postpartum, with pregnancy and birth outcomes recorded through hospital discharge.

Who should consider this trial

Good fit: Healthy pregnant women aged 18-39 years between 20 and 32 weeks' gestation who have not received an influenza vaccine in the past 6 months and have no major pregnancy complications.

Not a fit: Women who recently received a seasonal influenza vaccine, who have significant pregnancy complications or a history of preterm delivery or spontaneous abortion, or who test positive for excluded infections may not receive benefit from participation.

Why it matters

Potential benefit: If successful, the Sinovac QIV could offer pregnant women and their newborns increased protection against seasonal influenza through maternal vaccination and antibody transfer.

How similar studies have performed: Prior studies of inactivated seasonal influenza vaccines in pregnancy have generally shown good safety profiles and transfer of antibodies to infants, so this trial compares Sinovac QIV to an established vaccine.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Receipt of any seasonal influenza vaccine within 6 months prior to enrollment, or plans to receive other influenza vaccines during the study;
2. Participants with previous or concurrent dangerous pregnancy complications such as gestational diabetes mellitus (GDM), pregnant induced hypertension, preeclampsia and known uterine anomaly;
3. History of preterm delivery, or spontaneous abortion;
4. Known fetal congenital anomaly, e.g. genetic abnormality or major congenital malformation based on antenatal ultrasound;
5. Signs or symptoms of active preterm labor, defined as regular uterine contractions with cervical change (dilation/effacement);
6. History of Guillain-Barré syndrome within 6 weeks of a prior dose of any influenza vaccine;
7. Received any vaccine in the 4 weeks prior to study vaccination, or plans to receive any vaccine within 4 weeks after study vaccination;
8. Serious allergic reaction or other serious adverse reaction to any influenza vaccines or their components;
9. 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;
10. Diagnosed abnormal coagulation function (e.g., coagulation factor deficiency, coagulation disorders, or platelet abnormalities), or obvious bruising following venipuncture;
11. 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);
12. Current or history of severe neurological diseases (such as epilepsy, convulsions or seizures) or psychiatric disorders, or family history of psychiatric disorders;
13. Acute diseases or acute stage of chronic diseases within 7 days prior to vaccination;
14. Receipt of blood, blood-derived products or immunoglobulins within 3 months prior to vaccination or plans for such treatment in the study;
15. Alcoholism or history of drug abuse;
16. Receipt of other investigational drugs/vaccines within 30 days prior to enrollment, or plan to receive investigational drugs/vaccines during the study period;
17. Fever on vaccination day, with axillary temperature ≥ 37.3°C pre-vaccination;
18. Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.

Where this trial is running

Mandaluyong, National Capital Region and 1 other locations

• 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)

Study contacts

• Study coordinator: April Rose T. Nepomuceno

Conditions Influenza; pregnant women