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New treatment option for Influenza
Official title A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above
ClinicalTrials.gov ID: NCT07302256
What this study is testing
What is Influenza virus split vaccine (0.7mL/vial)?
Influenza virus split vaccine (0.7mL/vial) 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, blinded, controlled phase I clinical trial with a total of 120 participants aged ≥ 60 years. Experimental group: Influenza virus split vaccine (0.7mL/vial), control group 1: Influenza virus split vaccine, control group 2: placebo group.
- Phase 1: an early, usually small safety study
- 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 60 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age over 60 years old, gender not limited, and able to provide legal identification;
- Volunteers voluntarily participate in the study and sign an informed consent form;
- Volunteers have the ability to understand research procedures, use thermometers, scales, and fill out diary cards as required, and can participate in...
You likely can't join if
- On the day of enrollment, the axillary temperature was ≥ 37.3 ℃;
- Those who have had influenza in the past 6 months or meet the definition of influenza like cases;
- Have received any influenza vaccine within the past 12 months or have planned to receive any influenza vaccine during the study period;
- Allergies to any components of the research vaccine, history of allergic reactions to the use of gentamicin sulfate, history of severe allergies to...
- Suffering from a serious illness that prevents the completion of the entire study; Within 3 days prior to vaccination, there is an acute illness or...
- Have used antipyretic or analgesic drugs or anti allergic drugs within 3 days before vaccination;
See the full eligibility criteria
- Age over 60 years old, gender not limited, and able to provide legal identification;
- Volunteers voluntarily participate in the study and sign an informed consent form;
- Volunteers have the ability to understand research procedures, use thermometers, scales, and fill out diary cards as required, and can participate in all planned follow-up visits.
- On the day of enrollment, the axillary temperature was ≥ 37.3 ℃;
- Those who have had influenza in the past 6 months or meet the definition of influenza like cases;
- Have received any influenza vaccine within the past 12 months or have planned to receive any influenza vaccine during the study period;
- Allergies to any components of the research vaccine, history of allergic reactions to the use of gentamicin sulfate, history of severe allergies to any vaccine/drug, or history of asthma;
- Suffering from a serious illness that prevents the completion of the entire study; Within 3 days prior to vaccination, there is an acute illness or an acute exacerbation of a chronic disease;
- Have used antipyretic or analgesic drugs or anti allergic drugs within 3 days before vaccination;
- Have received any vaccine within 2 weeks prior to vaccination;
- Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months prior to receiving the experimental vaccine, For example, immunosuppressive doses of glucocorticoids, monoclonal antibodies...
- Suffering from congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, or other autoimmune diseases;
- Suffering from serious chronic diseases, serious cardiovascular diseases, such as hypertension that cannot be controlled by drugs, diabetes that cannot be controlled by drugs or has serious complications, liver and...
- Have received blood or blood related products within the past 6 months;
- Individuals with progressive neurological disorders, including a history of seizures, epilepsy, encephalopathy, Guillain Barr é syndrome, psychiatric or family history;
- Have a history of abnormal coagulation function and have been using anticoagulants within 3 weeks before vaccination;
- Patients with splenectomy, functional splenectomy, splenectomy, or other important organ resection or partial resection;
- Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit;
- Currently or recently planning to participate in other clinical trials;
- Abnormal laboratory test indicators before vaccination;
- Researchers determine any situation that is not suitable for clinical trials.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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, 60 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 Wuhan, Hubei, 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.