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
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:
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- 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.
- 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