Seasonal InfluenzaPhase 1NCT07889193
Phase I Clinical Trial of Trivalent Inactivated Split Influenza Virus Vaccine (MDCK Cell)
A Phase 1 study testing Cell-based Trivalent Split Influenza Virus Vaccine (cTIV) and Egg-based Trivalent Split Influenza Virus Vaccine (eTIV) in people with Seasonal Influenza, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
This study is a phase I, randomized, double-blind, placebo and active comparator-controlled clinical trial to evaluate the safety and immunogenicity of a trivalent split influenza virus vaccine (MDCK cell) developed by Sinovac Biotech Co., Ltd., in participants aged 6 months and above. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Seasonal Influenza
- What is being tested?
- Cell-based Trivalent Split Influenza Virus Vaccine (cTIV) and Egg-based Trivalent Split Influenza Virus Vaccine (eTIV)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy trial participants aged ≥6 months;
- Among them, for children aged 3-8 years:
- Influenza vaccine-naïve: children who have never received any influenza vaccine (licensed or investigational);
- Previously vaccinated: children who have received at least 1 dose of influenza vaccine (licensed or investigational);
- The trial participant and/or the participant's legal representative can understand and voluntarily sign the informed consent form;
- Willing and able to comply with all visit schedules, sample collection, vaccination and other trial procedures, and maintain contact at all times during the trial;
- Able to provide legal identification documents.
Who cannot join
- Receipt of any licensed or investigational influenza vaccine within the previous 18 months, or intention to receive any other influenza vaccine during the study;
- Clinically or laboratory-confirmed influenza infection within the previous 6 months;
- Known history of a severe allergic reaction to the study vaccine or any of its components, including urticaria, dyspnea, angioedema, or anaphylaxis;
- Fever on the scheduled day of study vaccination, defined as an axillary temperature >37.0°C before vaccination;
- Skin lesions, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with vaccination or the assessment of local reactions;
- Clinically significant laboratory abnormalities outside the reference ranges in any of the following parameters:
Show all 19Show fewer
- Hematology: white blood cell count, hemoglobin, or platelet count; Serum biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin; Urinalysis: urine protein;
- Severe congenital malformations or genetic disorders, including but not limited to Down syndrome or phenylketonuria;
- Poorly controlled chronic disease or a history of serious disease, including but not limited to cardiovascular disease, metabolic disease (e.g., poorly controlled diabetes mellitus), hematologic disease, hepatic or renal disease, gastrointestinal disease, respiratory disease, malignancy, or a history of major organ transplantation. For participants aged ≥18 years, hypertension inadequately controlled with medication is defined as: Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg for participants aged 18-59 years; Systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg for participants aged ≥60 years;
- Autoimmune disease, immunodeficiency disorder, or a relevant family history, including but not limited to Guillain-Barré syndrome (GBS), systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, anatomic asplenia, functional asplenia, or HIV infection;
- Coagulation abnormalities, including coagulation factor deficiency or platelet disorders;
- Current or previous severe neurologic disease, including epilepsy, convulsions, or seizures, except for a history of febrile seizures in infants or young children; severe psychiatric disorder; or a family history of schizophrenia;
- Receipt of immunosuppressive agents or other immunomodulatory therapy for ≥14 days within the previous 6 months, including prednisone at a dose of ≥20 mg/day or ≥2 mg/kg/day, or another systemic corticosteroid at an equivalent prednisone dose; receipt of cytotoxic therapy; or intention to receive any such therapy during the study. Topical and inhaled corticosteroids are excluded;
- Receipt of immunoglobulins or other blood products within the previous 3 months, or intention to receive such products during the study;
- Receipt of any other investigational drug or vaccine within the previous 30 days, or intention to receive any such drug or vaccine during the study;
- Receipt of a live attenuated vaccine or viral vector vaccine within the previous 14 days, or receipt of a subunit, inactivated, or other non-live vaccine within the previous 7 days;
- Any acute illness or acute exacerbation of a chronic disease within the previous 7 days, or any known or suspected active infection;
- Breastfeeding or pregnancy, including a positive urine pregnancy test, or an intention to become pregnant or donate oocytes from the time of signing the informed consent form until 6 months after study vaccine administration; for male participants, an intention to father a child or donate sperm during the same period;
- Any other condition that, in the investigator's judgment, would make the participant unsuitable for participation in the study.
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
Guangdong Provincial Center for Disease Control and Prevention (Guangdong Academy of Preventive Medical Sciences)
Guangzhou, Guangdong
Liao Yuyi, 15914307772, 727771666@qq.com
About this study
Official title: A Randomized, Double-Blind, Placebo and Positive-Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Trivalent Inactivated Split Influenza Virus Vaccine (MDCK Cell) in Participants Aged 6 Months and Above
This study is a phase I, randomized, double-blind, placebo and active comparator-controlled clinical trial to evaluate the safety and immunogenicity of a trivalent split influenza virus vaccine (MDCK cell) developed by Sinovac Biotech Co., Ltd., in participants aged 6 months and above.
Read the detailed description
A total of 175 healthy trial participants ≥6 months of age will be enrolled, including 50 children aged 6-35 months, 25 children aged 3-8 years, 50 children and adults aged 9-59 years, and 50 elderly participants aged ≥60 years. All trial participants will be randomized in a 2:2:1 ratio to the investigational group, active comparator group or placebo group. Children aged 6-35 months vaccine-naïve children aged 3-8 years will receive 2 doses of cell-based trivalent influenza vaccine (cTIV), egg-based trivalent influenza vaccine (eTIV), or placebo, with an interval of 28 days. Other trial participants will receive a single dose of investigational vaccine cTIV, eTIV, or placebo.
- Conditions
- Seasonal Influenza
- Being tested
- Cell-based Trivalent Split Influenza Virus Vaccine (cTIV), Egg-based Trivalent Split Influenza Virus Vaccine (eTIV), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell-based Trivalent Split Influenza Virus Vaccine (cTIV)Biological
Investigational trivalent split influenza virus vaccine produced in MDCK cells, administered intramuscularly.
Egg-based Trivalent Split Influenza Virus Vaccine (eTIV)Biological
Licensed trivalent split influenza virus vaccine (Anflu) produced in embryonated chicken eggs, administered intramuscularly.
PlaceboOther
0.9% normal saline for intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Group :Cell-based Trivalent Split Influenza Virus Vaccine (cTIV) | Experimental | Children aged 6-35 months and vaccine-naïve children aged 3-8 years: 2 doses administered 28 days apart.
All other participants: 1 single dose Receives: Biological: Cell-based Trivalent Split Influenza Virus Vaccine (cTIV) |
| Active Comparator Group: Egg-based Trivalent Split Influenza Virus Vaccine (eTIV) | Active comparator | Children aged 6-35 months and vaccine-naïve children aged 3-8 years: 2 doses administered 28 days apart.
All other participants: 1 single dose Receives: Biological: Egg-based Trivalent Split Influenza Virus Vaccine (eTIV) |
| Placebo Group: Placebo | Placebo comparator | Children aged 6-35 months and vaccine-naïve children aged 3-8 years: 2 doses administered 28 days apart.
All other participants: 1 single dose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reactions
Incidence of adverse reactions from Day 0 to Day 28 after each dose
Measured: 0-28 days after each dose
Secondary outcomes (7)
Incidence of adverse reactions
Incidence of adverse reactions from Day 0 to Day 7 after each dose
Measured: 0-7 days after each dose
Incidence of serious adverse events(SAEs)
Incidence of SAEs from the first dose up to 6 months after the last dose
Measured: From the first dose up to 6 months after the last dose
Incidence of abnormal and clinically significant hematology, serum biochemistry and urinalysis parameters on Day 3 after vaccination
Incidence of laboratory abnormalities with clinical significance in hematology, serum biochemistry and urinalysis collected on Day 3 post-vaccination among trial participants.
Measured: Day 3 after vaccination
The geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after completion of full vaccination.
GMT for each vaccine-related influenza strain, assessed at Day 28 after full vaccination.
Measured: Day 28 after completion of full vaccination
The geometric mean increase (GMI) of HI antibodies against each antigen 28 days after full vaccination.
GMI for each vaccine-related influenza strain, assessed at Day 28 after full vaccination.
Measured: Day 28 after full vaccination
The seroconversion rates of HI antibodies against each antigen 28 days after full vaccination.
Seroconversion rate for each vaccine-related influenza strain, assessed at Day 28 after full vaccination.
Measured: Day 28 after full vaccination
The seroprotection rates of antibodies against each antigen 28 days after full vaccination.
Seroprotection rate (HI titer ≥1:40) for each vaccine-related influenza strain, assessed at Day 28 after full vaccination.
Measured: Day 28 after completion of full vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liao Yuyi, Principal investigator, Guangdong Provincial Center for Disease Control and Prevention (Guangdong Academy of Preventive Medical Sciences)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889193
- Sponsor's protocol ID
- PRO-cINF-1001
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo and Positive-Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Trivalent Inactivated Split Influenza Virus Vaccine (MDCK Cell) in Participants Aged 6 Months and Above
- ClinicalTrials.gov ID
- NCT07889193
- Acronym / sponsor ID
- PRO-cINF-1001
- Conditions
- Seasonal Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Oct 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 study is a phase I, randomized, double-blind, placebo and active comparator-controlled clinical trial to evaluate the safety and immunogenicity of a trivalent split influenza virus vaccine (MDCK cell) developed by Sinovac Biotech Co., Ltd., in participants aged 6 months and above.
Detailed description
A total of 175 healthy trial participants ≥6 months of age will be enrolled, including 50 children aged 6-35 months, 25 children aged 3-8 years, 50 children and adults aged 9-59 years, and 50 elderly participants aged ≥60 years. All trial participants will be randomized in a 2:2:1 ratio to the investigational group, active comparator group or placebo group. Children aged 6-35 months vaccine-naïve children aged 3-8 years will receive 2 doses of cell-based trivalent influenza vaccine (cTIV), egg-based trivalent influenza vaccine (eTIV), or placebo, with an interval of 28 days. Other trial participants will receive a single dose of investigational vaccine cTIV, eTIV, or placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational Group :Cell-based Trivalent Split Influenza Virus Vaccine (cTIV) | Experimental | Biological: Cell-based Trivalent Split Influenza Virus Vaccine (cTIV)Children aged 6-35 months and vaccine-naïve children aged 3-8 years: 2 doses administered 28 days apart. All other participants: 1 single dose |
| Active Comparator Group: Egg-based Trivalent Split Influenza Virus Vaccine (eTIV) | Active comparator | Biological: Egg-based Trivalent Split Influenza Virus Vaccine (eTIV)Children aged 6-35 months and vaccine-naïve children aged 3-8 years: 2 doses administered 28 days apart. All other participants: 1 single dose |
| Placebo Group: Placebo | Placebo comparator | Other: PlaceboChildren aged 6-35 months and vaccine-naïve children aged 3-8 years: 2 doses administered 28 days apart. All other participants: 1 single dose |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy trial participants aged ≥6 months;
- The trial participant and/or the participant's legal representative can understand and voluntarily sign the informed consent form;
- Willing and able to comply with all visit schedules, sample collection, vaccination and other trial procedures, and maintain contact at all times during the trial;
- Able to provide legal identification documents.
Key exclusion criteria (19 listed)
- Receipt of any licensed or investigational influenza vaccine within the previous 18 months, or intention to receive any other influenza vaccine during the study;
- Clinically or laboratory-confirmed influenza infection within the previous 6 months;
- Known history of a severe allergic reaction to the study vaccine or any of its components, including urticaria, dyspnea, angioedema, or anaphylaxis;
- Fever on the scheduled day of study vaccination, defined as an axillary temperature >37.0°C before vaccination;
- Skin lesions, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with vaccination or the assessment of local reactions;
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 |
|---|---|---|
| Cell-based Trivalent Split Influenza Virus Vaccine (cTIV)Investigational trivalent split influenza virus vaccine produced in MDCK cells, administered intramuscularly. | Biological | Investigational Group :Cell-based Trivalent Split Influenza Virus Vaccine (cTIV) |
| Egg-based Trivalent Split Influenza Virus Vaccine (eTIV)Licensed trivalent split influenza virus vaccine (Anflu) produced in embryonated chicken eggs, administered intramuscularly. | Biological | Active Comparator Group: Egg-based Trivalent Split Influenza Virus Vaccine (eTIV) |
| Placebo0.9% normal saline for intramuscular injection. | Other | Placebo Group: Placebo |
Primary outcome
Incidence of adverse reactions
Time frame: 0-28 days after each dose
Incidence of adverse reactions from Day 0 to Day 28 after each dose
7 secondary outcomes
Incidence of adverse reactions
Time frame: 0-7 days after each dose
Incidence of serious adverse events(SAEs)
Time frame: From the first dose up to 6 months after the last dose
Incidence of abnormal and clinically significant hematology, serum biochemistry and urinalysis parameters on Day 3 after vaccination
Time frame: Day 3 after vaccination
The geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after completion of full vaccination.
Time frame: Day 28 after completion of full vaccination
The geometric mean increase (GMI) of HI antibodies against each antigen 28 days after full vaccination.
Time frame: Day 28 after full vaccination
The seroconversion rates of HI antibodies against each antigen 28 days after full vaccination.
Time frame: Day 28 after full vaccination
The seroprotection rates of antibodies against each antigen 28 days after full vaccination.
Time frame: Day 28 after completion of full vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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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.
Liao Yuyi principal investigator
Guangdong Provincial Center for Disease Control and Prevention (Guangdong Academy of Preventive Medical Sciences)
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 Cell-based Trivalent Split Influenza Virus Vaccine (cTIV) and Egg-based Trivalent Split Influenza Virus Vaccine (eTIV) in people with Seasonal 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 7 inclusion and 19 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: opening soon, as of the sponsor's last update on 22 Oct 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liao Yuyi (15914307772, 727771666@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse reactions (time frame: 0-28 days after each dose). 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 22 Oct 2026.