BridgeMD
New treatment option for Influenza, Human
Official title Clinical Trials of Quadrivalent Influenza Vaccine
ClinicalTrials.gov ID: NCT06824519
What this study is testing
What is Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose)?
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose) is an investigational medicine, being studied as a potential treatment for influenza, human.
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 clinical trial adopts a seamless design of phase I/II, conducted in two stages: phase I and phase II. Phase I is the age/dose ramp up stage, and phase II is the dose expansion stage.The purpose of this clinical trial is to evaluate the safety and tolerability of different doses of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant，explore the immunogenicity of the vaccine, and determine the appropriate dose for later clinical trials of this product.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- When signing the informed consent form, be at least 18 years old and provide valid identification;
- The subject is able to understand the procedures and methods of this clinical trial, has given sufficient informed consent, voluntarily participated...
- On the day of enrollment, axillary temperature was ≤ 37.0 ℃;
- Female and male participants of childbearing age: agree to take effective contraceptive measures within 6 months after vaccination.
You likely can't join if
- The laboratory test indicators specified in the protocol are abnormal and clinically significant before vaccination (only for Phase I);
- Have contracted influenza within the past 6 months prior to enrollment (confirmed by any clinical or microbiological method);
- Previously or currently suffering from autoimmune or immunodeficiency diseases;
- Previous history of severe allergies to any vaccine/drug or any component of the experimental vaccine, such as anaphylactic shock, allergic laryngeal...
- Have received any influenza vaccine within the 6 months prior to enrollment, or plan to receive influenza vaccine other than the vaccine used in this...
- Within 30 days prior to enrollment, any investigational or unregistered products (drugs, vaccines, or devices) have been used, or are planned to be...
See the full eligibility criteria
- When signing the informed consent form, be at least 18 years old and provide valid identification;
- The subject is able to understand the procedures and methods of this clinical trial, has given sufficient informed consent, voluntarily participated, and signed an informed consent form by the subject themselves;
- On the day of enrollment, axillary temperature was ≤ 37.0 ℃;
- Female and male participants of childbearing age: agree to take effective contraceptive measures within 6 months after vaccination.
- The laboratory test indicators specified in the protocol are abnormal and clinically significant before vaccination (only for Phase I);
- Have contracted influenza within the past 6 months prior to enrollment (confirmed by any clinical or microbiological method);
- Previously or currently suffering from autoimmune or immunodeficiency diseases;
- Previous history of severe allergies to any vaccine/drug or any component of the experimental vaccine, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, respiratory...
- Have received any influenza vaccine within the 6 months prior to enrollment, or plan to receive influenza vaccine other than the vaccine used in this trial during the trial period (before completing the immunization and...
- Within 30 days prior to enrollment, any investigational or unregistered products (drugs, vaccines, or devices) have been used, or are planned to be used during the trial period (except for the vaccine used in this...
- The interval between receiving attenuated live vaccines before enrollment is less than 30 days, and the interval between receiving other non live vaccines is less than 14 days;
- Within the first 3 days of enrollment, have experienced acute illness or are in the acute phase of chronic illness;
- Used antipyretic, analgesic, or anti allergic drugs within 3 days prior to enrollment;
- Use immunoglobulin and/or any blood products within 3 months prior to enrollment, or plan to use them during the trial period (before completing immunization and collecting blood samples);
- Long term use of immunosuppressants or other immunomodulatory drugs (defined as continuous use for more than 14 days) within the first 3 months of enrollment, such as a glucocorticoid dose of ≥ 0.5 mg/kg/day (inhalation...
- Absence of spleen, functional absence of spleen, and splenectomy caused by any condition;
- Any obvious coagulation dysfunction or history of anticoagulant therapy;
- History of epilepsy, encephalopathy, and malignant tumors;
- Suffering from serious cardiovascular system diseases, serious hypertension with unstable drugs (systolic pressure ≥ 160mmHg and/or diastolic pressure ≥ 100mmHg), diabetes with serious complications and other serious...
- Currently suffering from respiratory system diseases (including pneumonia, tuberculosis, severe asthma, chronic bronchitis, etc.), acute liver and kidney diseases (severe impairment of liver and kidney function), mental...
- Women of childbearing age who are breastfeeding, pregnant, or have a positive urine pregnancy test before enrollment;
- Plan to move out of the local area before the end of the study or plan to leave the local area for a long time during the study visit;
- According to the researchers' judgment, the people have any other factors that are not suitable for participating in the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shijiazhuang, Hebei, China
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 all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shijiazhuang, Hebei, China. 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.