BridgeMD
New treatment option for Influenza
Official title Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Pregnant Women
ClinicalTrials.gov ID: NCT07211152
What this study is testing
What is 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 is an investigational medicine, being studied as a potential treatment for influenza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 39, women only. Healthy volunteers may be eligible.
You may be able to join 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;
You likely can't join 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...
- 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;
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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;
- Receipt of other investigational drugs/vaccines within 30 days prior to enrollment, or plan to receive investigational drugs/vaccines during the study period;
- Fever on vaccination day, with axillary temperature ≥ 37.3°C pre-vaccination;
- Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Mandaluyong, National Capital Region, Philippines
- Manila, National Capital Region, Philippines
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 39 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mandaluyong, National Capital Region, Philippines; Manila, National Capital Region, Philippines. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.