Influenza split vaccine for people aged 60 and older

A Randomized, Double-blind, Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above

This trial will test whether a split influenza vaccine is safe and triggers an immune response in people aged 60 and older compared with a different vaccine formulation and a placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Shanghai Institute Of Biological Products (Industry-sponsored)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07302256 on ClinicalTrials.gov

What this trial studies

This randomized, blinded, controlled Phase I trial enrolls 120 participants aged 60 years and above and randomizes them 1:1:1 into three groups of 40. One group receives an experimental influenza virus split vaccine (0.7 mL), a second group receives a comparator influenza split vaccine, and a third group receives a placebo (phosphate-buffered solution), each given as a single intramuscular injection in the deltoid. Participants have laboratory tests before vaccination and on day 4 after vaccination, and safety and immunogenicity outcomes are monitored through follow-up visits and diary cards. The primary goal is to gather early safety data and signals of immune response in an older adult population.

Who should consider this trial

Good fit: Ideal candidates are people aged 60 years or older who can give informed consent, use a thermometer and scale, complete diary cards, and attend all planned follow-up visits.

Not a fit: People with recent fever, recent influenza or influenza-like illness, recent or planned influenza vaccination, known allergies to vaccine components, severe allergic history or asthma, or serious illnesses preventing study completion are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, the vaccine could offer a safer or more effective way to protect older adults from influenza.

How similar studies have performed: Split influenza vaccines are widely used and prior studies have shown acceptable safety and immune responses in older adults, though specific formulations and dosing can change results.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

* 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, thymosin, interferon, etc., or planned to receive such treatment within one month after the first dose of vaccination to full immunization, but local medication is allowed;
* 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 kidney diseases, pulmonary edema, malignant tumors, etc;
* 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.

Where this trial is running

Wuhan, Hubei

• Danjiangkou Disease Prevention and Control Center — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Yeqing Tong — Hubei Provincial Center for Disease Control and Prevention
• Study coordinator: Yang Liu

Conditions Influenza; Influenza virus split vaccine; The elderly; Immunogenicity; Safety