Phase Ⅱ Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above
- Summary
- To evaluate the immunogenicity of administering one dose of influenza virus split vaccine (0.7mL/dose) to individuals aged 60 and above.
- Short title
- Phase Ⅱ Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above
- Official title
- A Randomized, Double-blind, Active-controlled Phase Ⅱ Clinical Trial to Evaluate the Immunogenicity and Safety of the Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-09-30
- First posted
- 2026-01-08
- Registry last updated
- 2026-01-15
- Primary completion date
- 2026-09-30
- Start date
- 2026-01-07
- Participants
- 1,200
- Participant count basis
- Estimated
- Planned participants
- 1,200
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Institute Of Biological Products
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07327398
- ClinicalTrials.gov ID
- NCT07327398
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Seroconversion rate
Timeframe: 30 days after vaccination
30 days after vaccination of all participants with the experimental vaccine or control vaccines, the HI antibody seroconversion rate against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Ratio of ≥1:40
Timeframe: 30 days after vaccination
30 days after vaccination of all participants with the experimental vaccine or control vaccines, the ratio of HI antibody titers ≥ 1:40 against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Geometric mean titer (GMT)
Timeframe: 30 days after vaccination
30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMT of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Geometric mean increase (GMI)
Timeframe: 30 days after vaccination
30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMI of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Solicited Adverse Events (AEs)
Timeframe: 7 days after vaccination
Adverse events defined by the protocol that occurred to the participant during 0-7 days after vaccination.
Unsolicited Adverse Events
Timeframe: 30 days after vaccination
Other adverse events that occurred among participants within 0-30 days after vaccination, in addition to the solicited adverse events.
Serious Adverse Events (SAEs)
Timeframe: 6 months after vaccination
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 60 Years
- Healthy volunteers
- Yes
- 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, 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;
- Researchers determine any situation that is not suitable for clinical trials.
- Danjiangkou City Center for Disease Control and PreventionWuhan, China
- Yunxi County Center for Disease Control and PreventionWuhan, China
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Influenza Primary condition