InfluenzaPhase 1NCT07302256
A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above
A Phase 1 study testing Influenza virus split vaccine (0.7mL/vial), Influenza virus split vaccine and Phosphate buffer solution (PBS) in people with Influenza, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza virus split vaccine (0.7mL/vial), Influenza virus split vaccine and Phosphate buffer solution (PBS)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2025to 31 Aug 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Danjiangkou Disease Prevention and Control Center
Wuhan, Hubei
Yunbo Pan, 86-15897801799, 2792320450@qq.com
About this study
Official title: 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 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. The three groups were recruited at a ratio of 1:1:1, and 40 individuals were randomly vaccinated in each group. Each person was injected with one dose of the vaccine into the deltoid muscle of the upper arm. Participants in each study group are required to undergo laboratory indicator tests before and on the 4th day after vaccination.
- Conditions
- Influenza
- Being tested
- Influenza virus split vaccine (0.7mL/vial), Influenza virus split vaccine, Phosphate buffer solution (PBS)
- Keywords
- Influenza virus split vaccine, The elderly, Immunogenicity, Safety
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza virus split vaccine (0.7mL/vial)Biological
Influenza virus split vaccine, with a specification of 0.7mL/bottle, containing 60 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each
Influenza virus split vaccineBiological
Influenza virus split vaccine, with a specification of 0.5mL/bottle, containing 15 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each
Phosphate buffer solution (PBS)Biological
PBS, with a specification of 0.5mL/bottle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Influenza virus split vaccine, with a specification of 0.7mL/bottle Receives: Biological: Influenza virus split vaccine (0.7mL/vial) |
| Control group 1 | Active comparator | Influenza virus split vaccine, with a specification of 0.5mL/bottle Receives: Biological: Influenza virus split vaccine |
| Control group 2 | Placebo comparator | Phosphate buffer solution Receives: Biological: Phosphate buffer solution (PBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unsolicited Adverse Events
Other adverse events that occurred among participants within 0-30 days after vaccination, in addition to the solicited adverse events.
Measured: 30 days after vaccination
Solicited Adverse Events (AEs)
Adverse events defined by the protocol that occurred to the participant during 0-7 days after vaccination.
Measured: 7 days after vaccination
Serious Adverse Events (SAE)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Measured: 6 months after vaccination
Secondary outcomes (4)
Seroconversion rate
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.
Measured: 30 days after vaccination
Ratio of ≥1:40
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.
Measured: 30 days after vaccination
Geometric mean titer (GMT)
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.
Measured: 30 days after vaccination
Geometric mean increase (GMI)
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.
Measured: 30 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start16 Dec 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yeqing Tong, Principal investigator, Hubei Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302256
- Sponsor's protocol ID
- SIBP-V05-001
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No