InfluenzaPhase 1NCT07737106
Phase I Clinical Trial of Influenza Vaccine (Split Virion), Inactivated (High Dose)
A Phase 1 study testing Influenza Vaccine (Split Virion), Inactivated (High Dose) and Influenza Vaccine (Split Virion), Inactivated in people with Influenza, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, active-controlled Phase I clinical trial to evaluate the safety and immunogenicity of Influenza Vaccine (Split Virion), Inactivated (High Dose) developed by Sinovac. 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 Vaccine (Split Virion), Inactivated (High Dose) and Influenza Vaccine (Split Virion), Inactivated
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2025to 24 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Participants aged 60 years and older who are in stable health condition.
- Participants who are fully informed and voluntarily sign the informed consent form.
- Participants who are willing and able to comply with all study procedures and remain contactable throughout the study.
- Participants who are able to provide valid legal identification.
Who cannot join
- Participants who have received a seasonal influenza vaccine within 6 months before enrollment, have received a seasonal influenza vaccine for the current influenza season, or plan to receive a seasonal influenza vaccine during the study.
- Participants who have had seasonal influenza within 6 months before enrollment.
- Participants with known severe allergy to any vaccine or vaccine component, such as urticaria, dyspnea, angioedema, or anaphylactic shock.
- Participants with poorly controlled chronic diseases or a history of serious diseases, including but not limited to cardiovascular diseases, such as hypertension not controlled by medication (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg measured at the study site) or coronary heart disease; metabolic diseases, such as poorly controlled diabetes; hematologic diseases; hepatic or renal diseases; digestive system diseases; respiratory system diseases; malignant tumors; a history of major organ transplantation; or any other disease or physiological condition that, in the investigator's opinion, may interfere with the study results.
- Participants with autoimmune diseases or immunodeficiency diseases, including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, or HIV infection.
- Participants with coagulation disorders, such as coagulation factor deficiency or platelet abnormalities.
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- Participants with current or previous severe neurological disease or psychiatric disease, or a family history of psychiatric disease.
- Participants with a history of long-term alcohol abuse or drug abuse.
- Participants with a history of Guillain-Barré syndrome (GBS).
- Participants who have received immunosuppressive agents or other immunomodulatory therapy for ≥14 days within the past 6 months (prednisone ≥20 mg/day or equivalent), cytotoxic therapy, or plan to receive such therapy during the study. Corticosteroid spray therapy for allergic rhinitis and topical corticosteroid therapy for acute uncomplicated dermatitis are excluded from this criterion.
- Participants who have received immunoglobulin or other blood products within 3 months before receiving the study vaccine, or plan to receive such treatment during the study.
- Participants who have received other investigational drugs or vaccines within 30 days before receiving the study vaccine, or plan to receive such drugs or vaccines during the study.
- Participants who have received live attenuated vaccines or RNA vaccines within 14 days before receiving the study vaccine.
- Participants who have received subunit or inactivated vaccines within 7 days before receiving the study vaccine.
- Participants with any acute disease, acute exacerbation of a chronic disease, or known or suspected active infection within the past 7 days.
- Participants with fever on the planned day of study vaccination, defined as axillary temperature >37.0°C before vaccination.
- Participants who, in the investigator's opinion, have any other factors that make them unsuitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Urad Middle Banner Center for Disease Control and Prevention
Bayan Nur, Inner Mongolia, 015300
About this study
Official title: A Randomized, Double-blind, Active-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Influenza Vaccine (Split Virion), Inactivated (High Dose) in Adults Aged 60 Years and Older
This is a randomized, double-blind, active-controlled Phase I clinical trial to evaluate the safety and immunogenicity of Influenza Vaccine (Split Virion), Inactivated (High Dose) developed by Sinovac.
Read the detailed description
50 participants aged 60 years and older will be enrolled and randomly assigned in a 1:1 ratio to receive one dose of the investigational vaccine or the active control vaccine (Anflu®).
- Conditions
- Influenza
- Being tested
- Influenza Vaccine (Split Virion), Inactivated (High Dose), Influenza Vaccine (Split Virion), Inactivated
- 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 Vaccine (Split Virion), Inactivated (High Dose)Biological
A single 0.5 mL dose of the investigational high-dose split influenza virus vaccine will be administered by intramuscular (IM) injection into the deltoid muscle of the upper arm. Each dose contains 60 μg of hemagglutinin from each influenza virus strain used for the current influenza season.
Influenza Vaccine (Split Virion), InactivatedBiological
A single 0.5 mL dose of the active control standard-dose split influenza virus vaccine will be administered by intramuscular (IM) injection into the deltoid muscle of the upper arm. Each dose contains 15 μg of hemagglutinin from each influenza virus strain used for the current influenza season.
| Study group | Role | What they receive |
|---|---|---|
| Influenza Vaccine (Split Virion), Inactivated (High Dose) | Experimental | Participants will receive one dose of Influenza Vaccine (Split Virion), Inactivated (High Dose). Receives: Biological: Influenza Vaccine (Split Virion), Inactivated (High Dose) |
| Influenza Vaccine (Split Virion), Inactivated | Active comparator | Participants will receive one dose of the active control influenza vaccine. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Reactions
Measured: Day 0 to Day 28 after vaccination
Secondary outcomes (10)
Incidence of adverse reactions
Measured: Day 0 to Day 7
Incidence of serious adverse events
Measured: within 6 months after vaccination
Seropositive Rate of HI Antibodies
Measured: Day 14
Seroprotection Rate of HI Antibodies
Measured: Day 14
GMT of HI Antibodies
Measured: Day 14
GMI of HI Antibodies
Measured: Day 14
Seropositive Rate of HI Antibodies
Measured: Day 28
Seroprotection Rate of HI Antibodies
Measured: Day 28
GMT of HI Antibodies
Measured: Day 28
GMI of HI Antibodies
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start21 Aug 2025
- Primary completion18 Sep 2025
- Study completion24 Feb 2026
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.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737106
- Sponsor's protocol ID
- PRO-HINF-1001
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Influenza Vaccine (Split Virion), Inactivated (High Dose) in Adults Aged 60 Years and Older
- ClinicalTrials.gov ID
- NCT07737106
- Acronym / sponsor ID
- PRO-HINF-1001
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, active-controlled Phase I clinical trial to evaluate the safety and immunogenicity of Influenza Vaccine (Split Virion), Inactivated (High Dose) developed by Sinovac.
Detailed description
50 participants aged 60 years and older will be enrolled and randomly assigned in a 1:1 ratio to receive one dose of the investigational vaccine or the active control vaccine (Anflu®).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza Vaccine (Split Virion), Inactivated (High Dose) | Experimental | Biological: Influenza Vaccine (Split Virion), Inactivated (High Dose)Participants will receive one dose of Influenza Vaccine (Split Virion), Inactivated (High Dose). |
| Influenza Vaccine (Split Virion), Inactivated | Active comparator | Biological: Influenza Vaccine (Split Virion), InactivatedParticipants will receive one dose of the active control influenza vaccine. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged 60 years and older who are in stable health condition.
- Participants who are fully informed and voluntarily sign the informed consent form.
- Participants who are willing and able to comply with all study procedures and remain contactable throughout the study.
- Participants who are able to provide valid legal identification.
Key exclusion criteria (17 listed)
- Participants who have received a seasonal influenza vaccine within 6 months before enrollment, have received a seasonal influenza vaccine for the current influenza season, or plan to receive a seasonal influenza vaccine during the study.
- Participants who have had seasonal influenza within 6 months before enrollment.
- Participants with known severe allergy to any vaccine or vaccine component, such as urticaria, dyspnea, angioedema, or anaphylactic shock.
- Participants with poorly controlled chronic diseases or a history of serious diseases, including but not limited to cardiovascular diseases, such as hypertension not controlled by medication (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg measured at the study site) or coronary heart disease; metabolic diseases, such as poorly controlled diabetes; hematologic diseases; hepatic or renal diseases; digestive system diseases; respiratory system diseases; malignant tumors; a history of major organ transplantation; or any other disease or physiological condition that, in the investigator's opinion, may interfere with the study results.
- Participants with autoimmune diseases or immunodeficiency diseases, including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, or HIV infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza Vaccine (Split Virion), Inactivated (High Dose)A single 0.5 mL dose of the investigational high-dose split influenza virus vaccine will be administered by intramuscular (IM) injection into the deltoid muscle of the upper arm. Each dose contains 60 μg of hemagglutinin from each influenza virus strain used for the current influenza season. | Biological | Influenza Vaccine (Split Virion), Inactivated (High Dose) |
| Influenza Vaccine (Split Virion), InactivatedA single 0.5 mL dose of the active control standard-dose split influenza virus vaccine will be administered by intramuscular (IM) injection into the deltoid muscle of the upper arm. Each dose contains 15 μg of hemagglutinin from each influenza virus strain used for the current influenza season. | Biological | Influenza Vaccine (Split Virion), Inactivated |
Primary outcome
Incidence of Adverse Reactions
Time frame: Day 0 to Day 28 after vaccination
10 secondary outcomes
Incidence of adverse reactions
Time frame: Day 0 to Day 7
Incidence of serious adverse events
Time frame: within 6 months after vaccination
Seropositive Rate of HI Antibodies
Time frame: Day 14
Seroprotection Rate of HI Antibodies
Time frame: Day 14
GMT of HI Antibodies
Time frame: Day 14
GMI of HI Antibodies
Time frame: Day 14
Seropositive Rate of HI Antibodies
Time frame: Day 28
Seroprotection Rate of HI Antibodies
Time frame: Day 28
GMT of HI Antibodies
Time frame: Day 28
GMI of HI Antibodies
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Influenza Vaccine (Split Virion), Inactivated (High Dose) and Influenza Vaccine (Split Virion), Inactivated in people with Influenza, run by Sinovac Biotech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Reactions (time frame: Day 0 to Day 28 after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.